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The beginner's guide to the FDA 510(k)
This article is an excerpt from The beginner's guide to the 510(k) ebook.
Table of Contents
- Introduction
- 510(k) basics
- Contents of a Traditional 510(k)
- 510(k) submission and timelines
- Other 510(k) forms
Congratulations! You have successfully developed a new medical device. Now you need to take it to market. In the United States, this often means submitting a 510(k). A 510(k) is a structured package of information about your device and its performance and safety that you submit to the Food and Drug Administration (FDA) for “clearance” before you can sell your device in the U.S. In order to receive clearance from the FDA, your 510(k) will need to demonstrate that your medical device is substantially equivalent to another legally marketed device (called a predicate device). The substantial equivalence approval process is a simple equation that looks something like this:
The 510(k) is generally the most efficient route to market clearance in the U.S. because you show your device is safe and effective based on this substantial equivalence standard, instead of needing to present more extensive clinical trial data.
There are three types of 510(k): Traditional, Abbreviated, and Special. This eBook will begin with a general overview of the 510(k) process, including its purpose and benefits. Next, we will explore the Traditional 510(k) and the sections and components required in depth. Finally, we will look at the Special and Abbreviated 510(k).
FDA: background and device oversight
Before we explain what a 510(k) is let’s first talk generally about the FDA and device oversight. The FDA is the U.S. governmental agency responsible for overseeing medical devices, drugs, food, and tobacco products. When it comes to medical devices, the FDA’s mission is to “protect the public health by ensuring the safety, efficacy, and security of…medical devices.” At the same time, the FDA also has an interest in “advancing public health by helping to speed innovations.” In other words, the FDA’s goal is to make sure devices are safe and effective for public use, while also ensuring that devices have a quick and efficient path to market.
In order to achieve this balance of safety and efficiency, the FDA has three different levels of oversight depending on the risk level of the device: (1) exempt from premarket submission, (2) Premarket Notification, also known as 510(k), and (3) Premarket Approval (PMA).
When is a 510(k) required?
A 510(k) is required for medium risk devices that have a predicate on the market which can be used to demonstrate the safety and effectiveness of the new device. Meanwhile, a PMA is required for high-risk or novel devices which require a higher level of scrutiny to be confirmed safe and effective.
A 510(k) is not only required for new devices, but also for devices that have been modified in a way that could impact safety or effectiveness. This could include changes to the:
- Design
- Components
- Materials
- Chemical composition
- Energy source
- Manufacturing process
- Intended use
You must submit your 510(k) at least 90 days before marketing the device.
What Exactly is Substantial Equivalence?
Now that we know what a 510(k) is, let’s talk about the substantial equivalence standard. You’ll recall from the introduction that your 510(k) must show that the new (or modified) device is substantially equivalent to at least one other legally marketed device, called a predicate device. Substantial equivalence looks at the intended use and the technological characteristics of the two devices.
More specifically, you must show:
- that the new device has the same intended use as the predicate, and
- the differences between the two devices do not raise questions about the safety and effectiveness of the new device.
Now let’s take a closer look at intended use and technological characteristics.
Intended use
Intended use means the general purpose or function of the device. The FDA will look at your proposed labelling and your Indications of Use section of the 510(k) to determine the intended use of your device (this is covered in Chapter 2). Intended use includes:
Technological characteristics
Once the FDA has determined that a predicate device exists and that the new device and the predicate device have the same intended use, it will move on to compare the technological characteristics. Technological characteristics include:
- Materials
- Design
- Energy source
- Other device features
The two devices do not have to be identical, and in fact they almost never are. The key here is to demonstrate that any differences do not have a significant impact on safety or effectiveness. Here’s what to cover when you compare your device’s technological characteristics with that of the predicate device:
Overall description of the device design
- Engineering drawings or diagrams to explain the device and component parts.
- List of component parts and explanation of how each component contributes to the overall use and function of the device.
- Physical specifications: dimensions, weight, temperature, tolerances, etc.
Materials
- Detailed chemical formulation used in all materials of constructions (especially those that come into contact with a patient).
- Any additives, coatings, paint, or surface modifications.
- How materials have been processed and what state they’re in.
Energy Sources
- Use of batteries, electricity, etc.
Other technological features
- Software/hardware
- Features
- Density
- Porosity
- Degradation characteristics
- Nature of reagents
- Principle of the assay method
In deciding whether the differences in technological characteristics impact safety or effectiveness, the FDA will typically rely on descriptive information about the technological characteristics as well as non-clinical and clinical performance data.
Let’s look at an example: A manufacturer submits a 510(k) for a new type of contact lens. Both the new device and the predicate device are indicated for daily wear for the treatment of astigmatism. The predicate device is only available in a clear lens, but the new device comes in a line of colors, including purple tinted lenses.
Who is responsible for submitting a 510(k)?
The following four types of organizations may be responsible for submitting a 510(k):
Manufacturers
- End-of-line device manufacturers who will be placing a device on the U.S. market.
- Note: Does not apply to component part manufacturers unless components will be marketed independently.
Specification developers
- Companies that develop the specifications for a finished device which has been manufactured elsewhere
Repackers or relabelers
- Required to submit a 510(k) if they significantly alter the labeling or condition of the device, including modification of manuals, changing the intended use, deleting or adding warnings, contraindications, sterilization status.
- Note: This is rare. The manufacturer, not the repackager or labeler, is typically responsible for the 510(k) submission.
Importers
- Importers that introduce a new device to the U.S. market may need to submit a 510(k), if it hasn’t already been submitted by the manufacturer.
Now that we’ve covered the basics, let’s explore what actually goes into your 510(k).
A Traditional 510(k) should contain all the following components in the list below. In some cases, a particular section may not apply to your device. When that happens, it’s a good idea to include the section anyway and just state “This section does not apply” or “N/A” under that heading.
To continue reading this eBook including a detailed walk-through of all the Traditional 510(k) components, submission requirements and timelines, and an overview of the other 510(k) forms including the Abbreviated 510(k) and the Special 510(k), please register to download the full version
The ultimate guide to the China UDI system and database
This article is an excerpt from The ultimate guide to the China NMPA UDI system and database ebook.
Table of Contents
- Overview
- UDI basics and benefits
- UDI format requirements and issuing entities
- UDI database and submission requirements
- Implementation of UDI and the UDI database in China
The current Chinese medical device regulatory regime kicked-off in 2014 with the Regulation on Supervision and Administration of Medical Devices. This core set of registration requirements, modeled after the United States and European Union systems, established a set of device classifications (class I, II, and III) based on risk and procedures for obtaining market clearance for each type of device.
Medical devices in China are regulated by the National Medical Products Administration (NMPA). Class I devices, such as clinical laboratory equipment or non-invasive skin dressings, require only notification to the NMPA for marketing authorization, and that authorization does not expire. Class II and III devices such as implantable devices or devices with a measuring function require full registration and a formal review before market clearance can be obtained.
These initial regulations have been expanded since their introduction, adding accelerated pathways to market for certain products in certain regions, easing acceptance of clinical data from overseas, and more specific roles and responsibilities for local agents of international manufacturers. In addition, in 2019, the regulations added a provision that medical devices carry a unique device identification (UDI). China’s UDI requirements are similar to those in the US and European Union. They establish specific device ID and labeling requirements, as well as a central, state-administered database of devices.
This eBook walks through the basics of medical device UDIs, the specifics of China’s implementation, and how MedTech companies who market their devices in China can prepare for the full rollout of these regulations in the coming years.
A UDI is a unique alphanumeric code that is designed to identify medical devices sold in a particular country/region from manufacturing, through distribution, to use by a patient. Like other aspects of the medical device regulatory regime, the UDI system in China follows the approach taken by the United States FDA and European Commission, and is based on the guidance from the International Medical Device Regulators Forum (IMDRF). Generally, UDI systems are designed to improve patient safety and optimize care by:
- Increasing the traceability of medical devices, including field safety corrective actions
- Providing an unambiguous identification method for medical devices throughout distribution and use
- Making adverse event reports more accessible
- Reducing medical errors by providing detailed information related to the device
- Simplifying medical device documentation and making it more consistent
There are three components to the UDI system in China:
- UDI code: The actual UDI code can be assigned by one of three (3) issuing agencies and contains information about the product, it’s expiration date, and the manufacturing batch/lot it’s associated with.
- UDI labeling: Put simply, medical devices must carry the UDI code on them. The regulations stipulate how devices and their packaging must be labeled for compliance.
- UDI database: In addition to labeling, all device UDIs must be submitted to a central database that is administered by the NMPA.
The following sections explore each of these components in more detail.
The UDI code
The first element of the UDI system is the code itself. The UDI code is the alphanumeric identifier that is associated with a specific medical device. UDI codes have two (2) elements to them, the UDI device identifier (UDI-DI) or static portion, and the UDI production identifier (UDI-PI) or dynamic portion. You can see the two components in the UDI diagram below:
The UDI-DI contains information about the issuing entity—the organization that is authorized to assign UDI codes. In China, this can be one of three entities: GS1, an international barcode and electronic data interchange standards organization, and two domestic organizations: the Zhongguancun Industry & Information Research Institute (ZIIOT), and AliHealth. Additional details about the issuing agencies are covered in Chapter 2. In addition, the UDI-DI contains information about the manufacturer and the specific model or version of the device.
The UDI-PI contains information about the manufacturing and production of the device. This typically includes information about the lot or batch number in which the device was manufactured, the manufacturing date and expiration date for the device (if applicable), and the specific serial number for the device. Here you can see all of the components marked up using the same UDI example:
Note that each packaging permutation and level for a given device will need to be assigned its own UDI. So for example, let’s say that a company manufactures 5ml enteral (oral) syringes in two packaging options: 1 – packaged individually and 2 – packaged in a box of 5. Each packaging option would need its own UDI, despite the fact that the underlying product is the same.
Now looking at packaging levels, let’s assume that the manufacturer packages the single syringe offering into boxes of 6, and again into larger containers of 24. Each of those packaging options needs its own UDI as well.
Labeling
In addition to obtaining UDI code for each device as outlined in the previous section, medical device manufacturers are required to ensure that devices are appropriately labeled with the assigned UDI. This label is called the UDI Carrier. The UDI is represented in two forms on the UDI Carrier: a machine-readable form and a human-readable form.
The machine-readable form or automatic identification data capture (AIDC) is a barcode or some other technology that can be used to automatically capture UDI information. The NMPA regulations support 3 types of machine-readable formats: 1-dimensional barcode, 2-dimensional barcode, and radio-frequency identification (RFID).
The regulations note that “use of advanced automatic identification and data collection technologies is encouraged”—prompting manufacturers to use more modern 2D and RFID machine-readable carriers where possible. Note, however, that if a device uses RFID, the UDI Carrier must also include the UDI in barcode format.
The human-readable form or human-readable interpretation (HRI) is the numeric or alphanumeric code for the UDI that can be read and manually entered into systems.
The UDI Carrier should be included on the device and on all levels of packaging. The UDI Carrier must be clear and readable during the operation and use of devices. If there isn’t room on the device for both the human and machine-readable forms of the UDI, then manufacturers should prioritize the machine-readable form.
UDI database
The third component of the NMPA UDI system is the UDI database. This is a centralized database of UDI and product information, administered by the NMPA. Manufacturers are required to submit UDI information into the database within 60 days after a product is approved (for sale in China) and before it is commercialized. The database contains a more detailed product record than what is included in the UDI itself, and it is the responsibility of the manufacturer (and/or their in-country representative) to submit the information correctly, and ensure that it’s kept up to date.
Chapter 3 of this eBook goes into detail about the specific fields and data requirements for UDI database submissions.
To continue reading this eBook including information about UDI format requirements and issuing entities, implementation timelines, and affected device types, please register to download the full version.
The ultimate guide to the EU MDR/IVDR unique device identifier (UDI) System
This article is an excerpt from The ultimate guide to the EU MDR/IVDR UDI ebook.
Table of contents
- Overview
- UDI basics and benefits
- UDI format requirements and issuing entities
- UDI rules for specific device types
- Implementation of UDI and UDAMED in the European Union
- US vs EU UDI comparison
The EU Medical Device Regulation (2017/745) (“MDR”) and EU In Vitro Diagnosis Regulation (2017/746) (“IVDR”) introduce two new systems for information exchange: UDI (Unique Device Identifier) for device identification and EUDAMED (European Databank on Medical Devices) to centralize and disseminate information. UDI is a specific code assigned to all devices and higher levels of packaging. This will allow for devices being sold in the European market to be identified and traced through a globally harmonized approach. EUDAMED is the IT system developed by the European Commission to replace the EUDAMED2 database previously in place under the Medical Device Directives (MDD). EUDAMED is a multi-functional system that will be used to coordinate device registration, provide information about devices to industry professionals and the public, and highlight necessary safety details.
The EU MDR and IVDR UDI system is based upon the guidance of the International Medical Device Regulators Forum (IMDRF). It’s a globally harmonized system that’s designed to increase patient safety and optimize care.
UDI system goals
Increase patient safety
- Improve tracing of devices
- Reduce the presence of counterfeit devices
Ensure access to accurate information
- Unambiguous identification of devices throughout distribution and use
Improve post-market surveillance
- Improve accessibility of adverse event reports
Enhance supply chain Management
- Streamline supply chain process and inventory management
- Simplify medical device documentation processes
The UDI system has four key elements
Element 1: Assignment of UDI (UDI Components)
The first element of the UDI system is the assignment of a UDI. The UDI is a code of alphanumeric characters that acts as the access key to information about a specific medical device on the market. The EU MDR and EU IVDR requires that a UDI be assigned to all medical devices except for custom-made or investigational devices. There are three components of a UDI:
- Basic UDI-DI
- UDI (consisting of UDI-DI and UDI-PI)
- Packaging UDI (Note: This is not an official term used in the EU MDR and IVDR, but we’re using it to help explain the concept. The Packing UDI is part of the UDI itself.)
1. Basic UDI-DI
The Basic UDI-DI identifies the device group that a particular device fits into. A device group is a group of products that all share the same intended purpose, risk class, essential design, and manufacturing characteristics. A device group is generally classified by medical device manufacturers as a “Product Family” or “Product Category,” depending on the internal nomenclature used within the company. The Basic UDI-DI functions as a parent or higher-level descriptor of a device.
NOTE: There can only be one Basic UDI-DI per UDI-DI.
The Basic UDI-DI is not printed on the product itself or on the packaging of a product, but rather it must be included in the following documents and applications:
- Certificates (Including Certificate of Free Sale)
- EU Declarations of Conformity
- Techical Documentation
- Summary of Safety and Clinical Performance
2. UDI (UDI-DI and UDI-PI)
The second component is the UDI itself, which consists of two parts:
Device Identifier (DI)
Production Identifier (PI)
The UDI-DI (Device Identifier DI, also referred to as “static”) identifies specific, detailed information about a particular device. If any of the below details should change, the device will need a new UDI-DI.
- Name or trade name of the device
- Device version or model
- If labelled as a single use device
- Packaged as sterile
- Maximum number of uses
- Need for sterilization before use
- Quantity of devices provided in a package
- Critical warnings or contra-indication
- CMR/endocrine disruptors
NOTE: There can be several UDI-DIs for one Basic UDI-DI.
Meanwhile, the UDI-PI (Production Identifier PI, also referred to as "dynamic") contains manufacturing information (including serial number, lot/batch number, software identification, and manufacturing or expiry date or both types of dates.)
To better illustrate this concept of Basic UDI-DI and UDI (UDI-DI and UDI-PI), let’s use a syringe as an example. The Basic UDI-DI would identify the category of a syringe, for example, "Enteral (Oral) Syringe."
A 5ml Enteral (Oral) Syringe – Sterile (Color: Purple) would get a unique UDI-DI and a 10m Enteral (Oral) Syringe – Sterile (Color: Orange) would get a unique UDI-DI. Both products would be associated to the same Basic UDI-DI. In this case, the "Enteral (Oral) Syringe," which defines the category.
Each time that 5ml Enteral (Oral) Syringe – Sterile (Color: Purple) is manufactured at the same revision, it will get a new UDI-PI per lot. See the graphic below.
Each product is identical and therefore has the same UDI-DI. However, the UDI-PI changes to reflect the manufacturing date, lot number, expiry date, and serial number, as applicable.
The UDI will contain all device-specific information and have the same functions as the comparable database (GUDID) of the United States FDA. The main difference (in EUDAMED) is that the UDI data is divided into components of Basic UDI-DI, UDI, and Packaging UDI.
3. Packaging UDI
The third component of UDI is the Packaging UDI. (Note: This is not an official term used in the EU MDR and IVDR, but we’re using it to help explain the concept.)
Each level of packaging, except shipping containers, must receive its own unique UDI. Packaging UDI refers to the unique UDI assigned to higher levels of packaging instead of the device itself.
In the event of significant space constraints on the unit of use packaging, the UDI Carrier may be placed on the next higher packaging level.
Returning to our earlier example of syringes, if a manufacturer first packages a single sellable syringe into an individual box, this package would receive its own UDI-DI and UDI-PI.
If then the manufacturer packages those individual boxes into containers of six (6), those containers would receive their own UDI-DI and UDI-PI.
And finally, if the manufacturer packages those six (6) containers into cases of four (4), those cases would receive their own UDI-DI and UDI-PI.
Each of those levels of packaging must be assigned its own UDI-DI and UDI-PI. The initial syringe did not change, but the way it is packaged did, therefore, requiring its own UDI-DI and UDI-PI.
Element 2: Placing UDI on the device and/or packaging
The second element to the UDI system is the placing of the UDI on the device or on its packaging through what is referred to as a “UDI Carrier.” The UDI Carrier is the part of the label that contains the UDI information that is applied directly to the device or included on the device packaging. The UDI Carrier should have both a machine-readable portion (AIDC) and a human-readable portion (HRI). (Specific details about each element of the UDI will be covered in Chapter 2.)
- Machine-readable form – AIDC – (Automatic Identification and Data Capture) is a barcode or other machine-readable technology that can be accessed automatically by scanning the UDI information.
- Human-readable form – HRI – (Human Readable Interpretation) is the numeric or alphanumeric code, which can be manually entered into the system for access to the UDI information.
If there are space constraints limiting the use of both the AIDC and HRI on the label, then only the AIDC is required to appear. However, on devices that are intended to be used in home-health care or other non-medical facility settings, the HRI would be required to appear.
Single-use devices may contain the UDI Carrier on its lowest level of packaging rather than on the device itself.
Reusable devices must include the UDI Carrier on the device itself, unless any type of direct marking would interfere with the safety or performance of the device, or if it is not technologically feasible to directly mark the device. If so, this should be properly documented in your design history file.
Most importantly, the UDI Carrier must be readable for the intended lifecycle of the device.
Below is an example of a GS1 AIDC and HRI barcode label.
Element 3: Storage of UDI information by Economic Operators
Storage of UDI information by "Economic Operators" is the third element of the UDI system. 2017/745 Articles 2(35), 22(1), and 22(3) define an economic operator as:
- A manufacturer
- An authorized representative
- A distributor
- An importer
- An investigator for clinical investigations
- A person who sterilizes systems or procedure packs
Class III, implantable device:
According to EU MDR 2017/745 Annex II, the manufacturer shall keep an updated list of all UDIs that it has assigned. Economic operators and all health institutions are required to store, preferably by electronic means, the UDI of all the devices for which they have supplied or with which they have been supplied.
For Devices Other than Class III:
Member States are encouraged, and in some cases require, health institutions to store, preferably by electronic means, the UDI of the devices with which they have been supplied. The UDI must also be included in any field safety notice for reporting serious incidents and field safety corrective actions.
The EU MDR and EU IVDR also give the European Commission authority to make additional requirements regarding the submission or maintenance of UDI information. In making those decisions, the European Commission must consider six (6) areas:
- Confidentiality and data protection
- Risk-based approach
- Cost-effectiveness of the additional measures
- The need to avoid duplications in the UDI system
- The needs of the healthcare systems of the member states
- Harmonization with other medical device identification systems
To continue reading this eBook including information about the EUDAMED database, UDI format requirements and issuing entities, implementation timelines, and key differences between the EU and US UDI systems, please register to download the full version
IEC 62304: Standard for medical device software
What is IEC 62304?
IEC 62304:2006 / AMD 1:2015 is the current version of the international standard that defines the software lifecycle processes for software used in medical devices. IEC 62304:2006 is considered a harmonized standard, meaning that it is recognized by the FDA and other regulatory agencies around the world.
Note that this standard applies both to Software as a Medical Device (SaMD) and Software in a Medical Device (SiMD).
How is IEC 62304:2006 organized?
There are 9 chapters in IEC 62304. The first 4 chapters define the scope of the standard as well as references, terms, and general requirements. The following 5 chapters are as follows:
- Chapter 5 – Software Development Process. This chapter is the most important to fully understand because it defines the software development planning process, including requirements analysis, design, testing, and release processes.
- Chapter 6 – Software Maintenance. This chapter defines the need for a software maintenance plan, including implementation of a maintenance plan and issue analysis procedures.
- Chapter 7 – Software Risk Management. Identification of hazardous situations, risk control, verification, and risk management procedures assume that an organization-level risk management plan is in place following the ISO 14971 standard.
- Chapter 8 – Software Configuration Management. This includes change control and configuration status tracking.
- Chapter 9 – Software Problem Resolution. This chapter addresses investigating and reporting on problems, change control processes, trend analysis, and resolution testing and verification.
IEC 62304:2006 software risk categories
IEC 62304:2006 defines three classes of risk for medical device software based on the risk of harm from a hazardous situation which the software could cause or to which it could contribute. As with risk management systems for other medical devices, the procedures, controls, and processes for medical device software should be appropriate for the level of risk posed by the software.
- Class A – No injury or damage to health is possible.
- Class B – Injury is possible, but not serious.
- Class C – Death or serious injury is possible.
Software development and maintenance processes in IEC 62304
The software development process, as defined in Chapter 5 of this standard, lays out 8 process steps.
- Software development planning (5.1)
- Software requirements analysis (5.2)
- Software architectural design (5.3)
- Software detailed design (5.4)
- Software unit implementation and verification (5.5)
- Software integration and integration testing (5.6)
- Software system testing (5.7)
- Software release (5.8)
IEC 62304 recommended documentation
In general, the following list of deliverables is typically needed to establish conformance with IEC 62304:2006:
- Software development plan - Define processes, deliverables, and development activities. The plan should include the Life Cycle Activities, Risk Management Plan, Documentation Plan, Configuration Management Plan, Change Control process, and Problem Resolution process.
- Software verification plan - Describe the software test plan. Include all verification activities, such as code review, unit test and integration test plans, and the final system software verification test plan.
- Software classification – Classify the software based on risk level as Class A, B, or C per definitions in the standard. Classification should also be established per market-specific requirements (ie: FDA Class I, II, or III).
- Software description – High-level description of the software function, intended use, and technology used.
- Software requirement specifications - Include specifications for all requirements, including functional, performance, interface, and safety requirements.
- Software architecture - Include diagrams of subsystems, major components, and the interfaces between them. This can provide segregation of software entities for risk control.
- Software hazards analysis - The hazard analysis should identify potential hazards and the software components that could cause them. Include mitigations that feed back into the requirements. Be sure to include OTS and wireless QoS hazard analysis where applicable.
- Cybersecurity plan - Document cybersecurity controls and features, threat model, hazard analysis, and penetration testing.
- Detailed design descriptions - Include specifications detailing how the software is implemented.
- Off-the-shelf software list – Identify any OTS software used, including detailed information regarding source, version, and licensing.
- Code unit verification - Document the unit test and code review as performed to plan.
- Integration tests - Document the integration, regression, and OTS software testing performed per the plan.
- System software verification protocols - Document test protocols for final device software. Include requirements tracing and show coverage of requirements (using pass/fail criteria).
- Summary test report - Create a summary of all software verification per the verification and validation plan.
- Trace matrix - Link system requirements to software requirements to associated design specifications and test protocols in one document (typically a spreadsheet). Include software hazards with software mitigations.
- Revision level history - Document major revisions and releases made during development, including descriptions of each.
- Unresolved anomalies - Document any anomalies still present and their associated risk. Include justification for release.
- Software problem resolution process - Describe how reported problems are evaluated and investigated, including how change requests and any necessary regression testing will be handled.
Complying with IEC 62304
More than most other standards, IEC 62304 requires an understanding of multiple disciplines to ensure compliance. Be sure to include team members with expertise in software development, risk management, and regulatory affairs when defining processes related to this standard.
Complying with IEC 62304 is only part of what is required for market clearance for software as a medical device. In the U.S., a 510(k) submission is typically required. Read our 510(k) guide here.
RIM vs PLM software for medical device manufacturers
Regulatory affairs professionals at large medical device companies must manage heavy submission workloads, registrations for products currently on the market, and ever-changing regulatory requirements. Many RA teams are still relying on paper documents, spreadsheets, and other outdated tools and methods to complete this work, while others have taken steps toward digitization and automation of key processes.
Regulatory teams often struggle to find software tools designed specifically for them. Because the processes they manage are typically product-focused, RA teams may attempt to use software built for product design and engineering teams, including product lifecycle management (PLM) systems.
What is PLM software?
Product lifecycle management (PLM) applications provide a central system for managing everything from the design of a new product to testing and ongoing maintenance. PLM systems are typically used by multiple teams, including product design and engineering teams, to coordinate product-related processes. The core elements of a PLM system include:
- Document management of design files and process documents
- Product structure management (source of truth for bills of material)
- Product component detail tracking and approvals (attribute management)
- Workflow and project/task management for product-related processes
- Product version control
- Secure management and approval processes for engineering and product changes (ECNs, ECOs, etc.)
- Integration with CAD and PDM (product data management) tools
PLM software can be considered both a data warehouse and a secure project system. PLM systems are used for storing and retrieving all product design-related information; including version-specific manufacturing (CAD) drawings, specifications, and supplier requirements. These systems also manage the workflows associated with each stage of a product’s lifecycle, from the design process to product maintenance to end of life activities. For medical device manufacturers, the PLM system is typically where design history files and device master records are maintained.
What are RIM systems?
Regulatory information management (RIM) systems have been around for years in the pharmaceutical industry but are relatively new in the medical device industry. Holistic RIM systems enable users to create a single source of truth for all data associated with regulatory submissions and registration management. RA teams are able to focus on critical tasks by using RIM systems to digitize data and automate key processes.
RIM system functions are designed to support a range of regulatory activities across a product’s lifecycle. In addition to centralizing core regulatory data and managing regulatory registrations and certificates, RIM systems can also support:
- Submission planning, authoring, and assembly
- Market entrance requirements and pre-built submission templates
- Collaborative content authoring and project management
- UDI management
- Standards management
- Essential principles/GSPR management, including bulk updating
RIM systems also tend to be product-centric, structuring data around individual regulated products, but are focused on saleable products, components, and packages where PLM systems are focused on the manufactured items. This means that RIM systems can track product-specific data, such as sales status by country, and link standards with individual products to easily identify products affected by standards updates and assess their impact.
Integrating PLM and RIM systems
PLM systems will often be integrated with ERP systems to ensure the correct bills of material and other product details for the current version of the product are being used by the manufacturing system. PLM systems can also be integrated with eQMS (quality management systems) and RIM systems to ensure coordination of risk management activities, product updates, and quality data between the regulatory, quality, and product teams. Ideally, your regulatory team should be notified as early as possible of any planned updates or changes to a product that is in-market or pending market approval.
RIM for regulatory projects and processes
Digitization and automation of regulatory data are more critical as global regulations continue to change and become more complex. Getting a medical device to market is a difficult process, but RIM software cuts the time and costs associated with product registrations while providing tools essential for ensuring ongoing compliance. PLM systems are critical as well, but their focus on product design and other product details simply does not provide the functionality needed by regulatory teams. Integrate a strong PLM system with a holistic RIM system to give both your engineering and regulatory teams the tools they need to bring your products to market successfully and to maintain compliance. To get your regulatory ducks in a row, only a RIM system will do!
To learn more about the Rimsys RIM system, talk to one of our experts today.
The state of regulatory performance in 2023
Today at Rimsys, we unveiled the 2023 MedTech Regulatory Performance Report, a new set of insights into the state of medtech regulatory affairs. Compiled based on interviews with 200 regulatory professionals and executives, the study provides a detailed look into how regulatory teams are staffed, their processes, the tools they use, and ultimately how they perform.
Why did we create this study? There were two driving factors behind the research. The first was a common theme that we heard from a number of our customers: Regulatory leaders don’t have clear data and benchmarks. They don’t necessarily know how long a new market submission should take, and how to plan for or assess the work of their teams. While other studies look at the medtech industry broadly or the state of the regulatory profession, this study tries to build a comprehensive resource for regulatory (and company) leaders.
The second factor was really for ourselves and the team at Rimsys. As a company building solutions specifically for medtech regulatory affairs, we wanted more insight into where companies were successful, where they struggled, and where we can add value.
What did we find? Regulatory teams perform a lot of hero work and rate themselves highly for their accomplishments. At the same time there is a lot of opportunity for process improvements, and companies that invest in digital transformation for regulatory affairs see better performance.
Regulatory professionals are superheroes
Regulatory teams are generally pretty small. Most companies have less than 10 full-time regulatory professionals. These small teams complete an enormous amount of work. Last year on average, RA teams completed 50 license renewals, 50 license updates, and 10 new market submissions. This is impressive output.
Digging a bit under the covers, we found that this output relied heavily on the support of external consultants. 90% of companies use consultants to keep pace with their regulatory workload. Front-line employees also struggle with burnout. They were much more likely to report feeling under-resourced than regulatory leaders.
But process problems persist
A lot of regulatory work remains extremely manual. 70% of regulatory teams spend half their time or more on repetitive administrative tasks. All of this manual work increases the frequency of errors and required rework. 61% of companies reported a major non-compliance incident in the past 2 years.
Manual work also makes it difficult to complete regulatory projects in a timely fashion. Teams completed a lot of projects, but each took a long time. Over half of all companies spend 4 months or more on license renewals, license updates, and new market submissions.
Moving regulatory affairs forward
As regulatory requirements become more complex, there’s a natural question about how teams will work moving forward. MDR & IVDR in Europe have significantly increased the regulatory workload required to bring and keep products on the market. Will organizations be able to keep pace with the same resources, tools, and processes?
No, and the performance report shows that medtech companies are investing to improve their regulatory capabilities. The majority of companies are planning to increase the sizes of their RA teams in 2023, and 40% expect to increase their investments in regulatory software. Companies are increasingly adopting specialized software to better support regulatory processes.
Dig into the survey results
The full survey results provide insights into more aspects of regulatory performance. They show that companies need to take a deeper look into their processes and how regulatory resources are allocated. There are two ways to learn more:
- Visit the survey page to see the full results (the survey whitepaper can be downloaded at no cost)
- Watch the recording of our webinar with PA Consulting. We discuss the survey results in more detail and share our regulatory predictions for 2023
RIM vs eQMS software for medical device manufacturers
Regulatory affairs professionals at large medical device companies must manage heavy submission workloads, registrations for products currently on the market, and ever-changing regulatory requirements. Many RA teams are still relying on paper documents, spreadsheets, and other outdated tools and methods to complete this work, while others have taken steps toward digitization and automation of key processes.
Regulatory teams often struggle to find software tools designed specifically to help manage their regulatory projects. As a result, some RA teams attempt to repurpose software developed for other functions, such as electronic quality management systems (eQMS). While eQMS systems can provide some functionality that RA teams need, regulatory information management (RIM) software delivers a holistic platform designed to reduce administrative work and manage global compliance activities. In this post, we’ll compare eQMS and RIM software as they relate to regulatory compliance.
What is eQMS software?
Electronic quality management systems (eQMS) are software programs that help quality teams centrally store, monitor, and manage quality and compliance processes. These platforms are usually provided via cloud technology as software-as-a-service (SaaS) solutions. They aim to provide digitization and automation of critical tasks that quality teams traditionally handle manually, such as quality, compliance, and design processes. For medical device companies, these requirements are defined by multiple standards, most notably ISO 13485:2016, FDA 21 CFR Part 820, and the EU MDR.
Digitization and automation are growing trends in most industries, including regulatory affairs and quality management. As you know, medical device manufacturers, especially their quality and RA teams, must manage a large volume of data, of which accuracy and consistency are of the utmost importance. eQMS systems typically handle data and processes in support of the following:
- Document management
- Non-conformance tracking
- Audit management
- Risk management
- Corrective and preventive action (CAPA) management
- Training management
This means that while eQMS software provides some functions and certainly have information that RA teams can use, they are designed around the processes that quality teams are responsible for. RIM software, on the other hand, is designed specifically to help regulatory specialists work more effectively and efficiently.
What are RIM systems, and what do they do?
Regulatory information management (RIM) systems have been around for years in the pharmaceutical industry, but are relatively new in the medical device industry. Comprehensive RIM systems enable users to create a single source of truth for all data associated with regulatory submissions and registration management. These systems lighten the burden on RA teams by digitizing data and automating key processes.
RIM system functions are designed to support a range of regulatory activities across a product’s lifecycle. In addition to centralizing core regulatory data and managing regulatory registrations and certificates, RIM systems can also support:
- Submission planning, authoring, and assembly
- Market entrance requirements and pre-built submission templates
- Collaborative content authoring and project management
- UDI management
- Standards management
- Essential principles/GSPR management, including bulk updating
RIM systems also tend to be product-centric, structuring data around individual regulated products, as opposed to the process-centric approach taken by most eQMS systems. This means that RIM systems can track product-specific data, such as sales status by country, and link standards with individual products to easily identify products affected by standards updates and assess their impact.
Integrating eQMS and RIM systems
While processes in an eQMS system are designed to support quality and risk management requirements, they contain a lot of information that is relevant to regulatory affairs teams. RIM systems such as Rimsys are designed to integrate to eQMS, PLM, and ERP systems in order to coordinate processes and synchronize data. In the case of RIM and eQMS integrations, the systems can synchronize product master data to ensure smoother regulatory submissions and identify the impact of changing documentation on global product registrations and submissions. And Performance and testing data can be linked to digital essential principles tables.
RIM for regulatory projects and processes
Digitization and automation of regulatory data are more critical as global regulations continue to change and become more complex. Getting a medical device to market is a difficult process, but RIM software cuts the time and costs associated with product registrations while providing tools essential for ensuring ongoing compliance. Quality systems are critical as well, but their focus on risk management and corrective and preventative activities simply does not provide the functionality needed by regulatory teams. Integrate a strong eQMS system with a holistic RIM system to give both your quality and regulatory teams the tools they need to bring your products to market successfully and to maintain compliance. To get your regulatory ducks in a row, only a RIM system will do!
To learn more about the Rimsys RIM system, talk to one of our experts today.
6 reasons medtech companies shouldn't delay MDR certification
The latest announcement from the European Commission (EC) recommending an extension to the MDR transition period has led to sighs of relief throughout the healthcare community in the EU, where providers and patients have been concerned about the ongoing availability of life-saving medical devices. Medical device manufacturers, however, have no time to waste in moving forward with MDR certifications for their devices.
On January 6th, the EC adopted the proposal recommended a month earlier to delay the full implementation of the Medical Device Regulation (MDR). The EU’s parliament and council now needs to issue final approval for the proposal, which will be processed through an “accelerated co-decision procedure.” While the proposed changes give medical device manufacturers some breathing room in recertifying existing devices, the changes do not apply to all devices or all situations and are not designed to allow manufacturers to delay the entire process of becoming compliant with MDR requirements.
Yes, if the proposal is approved by the European Commission as it is written today, your MDD-certified device may be able to remain in the EU market longer – the end of 2027 for high-risk devices and 2028 for medium- and low-risk devices. So, why do regulatory teams need to push forward as quickly as possible with MDR certification projects?
1. No extension for IVD devices
The proposed extensions to the transition periods apply only to medical devices covered under the MDR. The original deadlines for IVD devices as defined by the IVDR remain in place:
- May 26, 2025 - Class D IVD devices
- May 26, 2026 - Class C IVD devices
- May 26, 2027 - Class A sterile IVD devices and Class B IVD devices.
2. Lack of Notified Body resources
In April, 2022, a survey of MedTech Europe members revealed that MDR certificates had not yet been issued for more than 85% of the 500,000+ medical devices certified under MDD or AIMDD. Currently, certifications for lower classifications of devices take approximately 10 to 18 months; and for more complex products, the certification timeline can be two years or more. The number of Notified Bodies certified to review MDR applications remains low, and even if Notified Bodies are able to add resources in the coming years, review timelines will only become longer as companies rush to certify the hundreds of thousands of devices expected to remain on the market. The challenges will be even greater for smaller manufacturers and others that do not already have an established relationship with a Notified Body.
What does this mean for medical device manufacturers today? For those with higher-risk class devices, assume a 2-year certification period – which means starting the process with a Notified Body as early as possible, given the unknown availability of NB resources in the near future. At the latest, manufacturers need to have signed with a Notified Body by September 26, 2024 (Per Annex VII, Section 4.3 of the MDR). And prior to starting that process, of course, all required data, processes, and documentation should be in place. This means that any manufacturer who has not started this process needs to do so now.
3. Inability to update devices
The postponed MDR deadlines only apply to devices that do not present any unacceptable risk to health and safety and have not undergone significant changes in design or intended purpose. Any medical device certified under the MDD to which significant changes are made will need to recertify under the MDR before the updated device is placed on the market.
4. EUDAMED and UDI compliance deadlines remain the same
While the exact deadlines for EUDAMED compliance are based on the actual (future) release dates of all modules, The European Commission expects requirements around vigilance, clinical investigation and performance studies, and market surveillance modules to become mandatory by the end of 2024. The Commission is proposing a longer transition period for UDI/device registration and the notified body certificate modules, with a mandatory compliance date around the 2nd quarter of 2026.
Note that the expected EUDAMED compliance dates are prior to the extended MDR compliance deadlines. This means that information not previously tracked under MDD requirements will be mandatory within the next few years. This includes UDI and device information, including Basic UDI-DI (BUDI-DI). Post-market surveillance (PMS) and periodic safety update reports (PSUR), requirements of the vigilance and market surveillance module, also become required upon EDUAMED implementation.
5. MDR certification may affect registrations in non-EU countries
An increasing number of countries outside of the EU will accept CE certification as a path to accelerated market approval. In some countries, such as China, proof of certification in the device’s country of origin is required. It is unclear how these requirements will change in recognition of MDR requirements and deadlines. If your current regulatory strategy requires country of origin for the European Union, you may experience a more burdensome application process in other markets.
6. Opportunity to create a competitive advantage
Instead of looking at MDR as an obstacle to overcome, medical devices manufacturers would be well advised to take this as an opportunity to create a competitive advantage. Companies without the necessary resources to re-certify all existing devices are expected to remove products from the EU market in the coming years. In addition, those companies who wait will likely experience higher costs and longer delays in obtaining certification – creating additional opportunities for their competitors.
And don’t forget that the transition period extensions apply only to legacy devices - any new products entering the EU market will require certification under MDR before being placed on the market!
If your data and processes aren’t yet fully ready for MDR, implementing a Regulatory Information Management (RIM) system as part of the process can create additional advantages beyond streamlining the MDR submission process. RIM systems digitize, automate, and simplify the submission and tracking of regulatory documents. The use of a RIM system not only speeds time to market, but provides regulatory teams tools for ensuring continued compliance for all products in all markets.
Doing nothing now is not an option
It is important to note that the extensions apply only to manufacturers that already have MDR compliance activities underway and have made an effort to become compliant, including the implementation of a compliant quality management system. Per Annex VII, Section 4.3 of the MDR, manufacturers must submit a formal application for a conformity assessment by May 26, 2024. In addition, the manufacturer and Notified Body must have signed a written agreement no later than September 26, 2024. The intent of the extended transition period is primarily to allow manufacturers to access Notified Body resources, and the Commission appears to be making an effort to limit any incentives for manufacturers to delay MDR certification.
We expect to see leaders in the medical device industry embracing MDR compliance not only as a way to keep revenue-generating devices in market, but as a way to gain a competitive advantage and market share in the coming years.
Want to learn more? Watch a replay of our recent webinar - Impact of the MDR transition period extension.
ISO 10993: Standards for the biologic evaluation of medical devices
The International Organization for Standardization (ISO) is the largest body in the world publishing standards. In fact, it is a conglomeration of standards bodies from over 160 countries working together to harmonize standards. As such, ISO 10993 is the international standard that is practically used globally for testing and determining the biocompatibility of medical devices. So it’s critical for medical device manufacturers to understand all 23 parts of ISO 10993 for the success of 510(k), pre-market authorization (PMA), and other device submission projects for regulatory authorities worldwide. As an example, the FDA has issued guidance on the Use of International Standard ISO 10993-1.
What is biocompatibility?
According to ISO 10993-1:2018, the current version of part 1 of the standard, biocompatibility is the ability of a medical device or material to perform with an appropriate host response in a specific application. Any device that comes into direct or indirect contact with the skin must be tested for biocompatibility. A medical device that makes indirect contact with the skin is one that encounters a liquid, gas, or another medium, that makes direct contact with the patient or user.
Categorizations for medical devices according to ISO 10993
When testing the biocompatibility of a device, it is broken down into two categories; one based on its type of contact with humans, and the other based on the duration of contact.
The categorizations for types of contact are:
- Non-contacting medical devices: These are medical devices that do not make direct or indirect contact with patients. Examples include in-vitro diagnostics devices, blood collection tubes, and petri dishes.
- Surface-contacting devices: Surface-contacting medical devices are ones that touch the skin, in-tact mucous membranes, and breached or compromised surfaces. Examples of these devices are catheters, contact lenses, and bronchoscopes.
- Externally communicating devices: Externally communicating devices are those that are partially or wholly external and come into contact with bodily fluids. These devices are usually intended to deliver or draw fluids to or from the body and are attached to an external delivery or withdrawal system. Examples include dialyzers and dialysis tubing accessories, transfer and transfusion sets, and arthroscopes.
- Implantable devices: Implantable devices are the riskiest type for medical devices because they are embedded within human tissue. Pacemakers, artificial larynxes, and heart valves are all implantable devices.
The categorizations for times of duration are:
- Limited exposure – Medical devices whose cumulative sum of single, multiple, or repeated duration of contact is up to 24 hours.
- Prolonged exposure – Medical devices whose cumulative sum of single, multiple, or repeated contact time is likely to exceed 24 hours but does not exceed 30 days.
- Long-term exposure – Medical devices whose cumulative sum of single, multiple, or repeated contact time exceeds 30 days.
Determining biocompatibility
Medical devices are most commonly made of metals, plastics, and fabrics, which are composed of chemicals with varying properties. Manufacturers must gather physical and chemical information about the device, which is vital to its biological and material evaluation and characterization.
For devices with components that are made of or utilize novel chemicals or materials, or those known to cause adverse effects, ISO 10993 requires rigorous risk assessment and management according to the standards of ISO 14971. Furthermore, there are prescribed data endpoints that set the foundation for determining the biocompatibility of medical devices and their intended uses and components.
The main things manufacturers must consider when determining the biocompatibility of medical devices and their components are listed below:
- Complete chemical characterization – ISO 10993 requires manufacturers to describe the chemical and material makeup of the medical device and its components, as well as the use of chemicals in the manufacturing of the device. Sometimes, a test of extractable and leachable chemicals is required to determine the safety of the medical device.
- Toxicological assessment – Toxicological assessment serves to determine and mitigate the risk of medical devices when they come into contact with patients and users. There are four pillars of toxicology assessment: hazard identification, hazard characterization, exposure assessment, and risk characterization.
- Biocompatibility testing – Biocompatibility testing is the process of testing the local and systemic effects of a medical device on the tissues it comes into contact with. Oftentimes a favorable toxicological assessment by a qualified individual, based on the facts of the thorough chemical characterization, can rule out the possibility of adverse effects and the need for biocompatibility testing.
ISO 10993 compliance
Biocompatibility assessment is a vital part of risk management according to ISO 14971. Ensuring compliance with risk management and biocompatibility assessment standards requires buy-in from all departments, from marketing and design to quality assurance and regulatory affairs.
It is vital that you begin considering ISO 10993-1:2018 in the early stages of product design. Part 1 of the standard will refer to additional parts, as listed in the following section. Completing your complete chemical characterization and toxicology assessment early in the process will help ensure the biocompatibility of your medical device during the design phase and expedite your device registration and time to market.
Also, it’s important to note that many regulatory authorities around the world have their own variation of ISO 10993. While these varying standards have the same foundation and are similar in many ways, you must understand their nuances if you plan to offer your medical device internationally.
ISO 10993 sections
ISO 10993 is made up of 23 different sections or parts, each of which is maintained and updated separately. Previews of the standard can be viewed on the ISO website, but full versions of the standard need to be purchased.
- ISO 10993-1:2018 – Evaluation and testing within a risk management system
- ISO 10993-2:2022 – Animal welfare requirements
- ISO 10993-3:2014 – Tests for genotoxicity, carcinogenicity, and reproductive toxicity
- ISO 10993-4:2017 – Selection of tests for interactions with blood
- ISO 10993-5:2009 – Tests for in vitro cytotoxicity
- ISO 10993-6:2016 – Tests for local effects after implantation
- ISO 10993-7:2008 – Ethylene oxide sterilization residuals
- ISO 10993-8: - Withdrawn (Selection of reference materials for biologic tests)
- ISO 10993-9:2019 – Framework for identification and quantification of potential degradation products
- ISO 10993-10:2021 – Tests for skin sensitization
- ISO 10993-11:2017 – Tests for systemic toxicity
- ISO 10993-12:2021 – Sample preparation and reference materials
- ISO 10993-13:2010 – Identification and quantification of degradation products from polymeric medical devices
- ISO 10993-14:2001 – Identification and quantification of degradation products from ceramics
- ISO 10993-15:2019 – Identification and quantification of degradation products from metals and alloys
- ISO 10993-16:2017 – Toxicokinetic study design for degradation products and leachables
- ISO 10993-17:2002 – Establishment of allowable limits for leachable substances
- ISO 10993-18:2020 – Chemical characterization of medical device materials within a risk management process
- ISO 10993-19:2020 – Physico-chemical, morphological, and topographical characterization of materials
- ISO 10993-20:2006 – Principles and methods for immunotoxicology testing of medical devices
- ISO 10993-22:2017 – Guidance on nanomaterials
- ISO 10993-23:2021 – Tests for irritation
How can we help?
Many manufacturers endure longer and more costly paths to market than necessary because they do not have systems and tools designed specifically for their regulatory teams. Furthermore, a lack of visibility and collaboration from departments that see regulatory teams traditionally as the “department of saying no” leaves ample room for human error in regulatory, quality management, and even marketing processes and activities. Read more about why we believe regulatory teams need to be considered revenue functions, not cost centers.
The resulting inefficiencies lead to problems such as marketing products with expired certificates, missing certificates, inaccurate and/or incomplete submissions, and even non-compliance with current regulatory requirements. Having a holistic RIM system is central to staying in compliance with standards, regulations, and guidance in the many markets around the world. Rimsys is the only RIM system of its kind built specifically for the medtech industry.
To learn how Rimsys can help your company get its regulatory ducks in a row, click here to schedule a demo.
