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Rimsys Announces Rimsys AI to Eliminate Repetitive Tasks and Enhance Decision-Making for MedTech Regulatory Teams
Rimsys, the leading Regulatory Information Management (RIM) platform for the MedTech industry, today announced the launch of Rimsys AI, a suite of embedded artificial intelligence (AI) agents.
The ultimate guide to the medical device single audit program (MDSAP)
This article is an excerpt from The ultimate guide to the medical device single audit program (MDSAP) ebook.
Table of contents
- What is MDSAP?
- History of MDSAP
- Who is responsible for the MDSAP?
- How does an MDSAP audit work?
- Audit sequence
- You got a nonconformity – now what?
- What does an MDSAP audit cost?
- Why choose the MDSAP certification process?
- Potential disadvantages of the MDSAP
- Ready to participate? – Here’s how to get started
- Completing a successful MDSAP audit
The Medical Device Single Audit Program (MDSAP) was designed and developed to allow a single audit of a medical device manufacturer to be applied to all country markets whose regulatory authorities are members of the program. The MDSAP provides efficient and thorough coverage of the standard requirements for medical device manufacturer quality management systems, and requirements for regulatory purposes (ISO 13485:2016). In addition, there are specific requirements of each medical device regulatory authority participating in the MDSAP that must be met:
- Conformity Assessment Procedures of the Australian Therapeutic Goods (Medical Devices) Regulations (TG(MD)R Sch3)
- Brazilian Good Manufacturing Practices (RDC ANVISA 16)
- Medical Device Regulations of Health Canada (ISO 13485:2003)
- Japan Ordinance on Standards for Manufacturing Control and Quality Control of Medical Devices and In Vitro Diagnostic Reagents (MHLW Ministerial Ordinance No 169)
- Quality System Regulation (21 CFR Part 820), and specific requirements of medical device regulatory authorities participating in the MDSAP program.
This means that a report from a single MDSAP audit of a medical device manufacturer would be accepted as a substitute for routine inspections by all the member Regulatory Authorities (RAs) across the world. There are currently five participating Regulatory Authorities (RA) representing the following countries: Australia, Brazil, Canada, Japan and the USA.
In April, 2021, the RAs released an “Audit Approach” document (MDSAP AU P0002.006) that combines the formerly separate MDSAP Audit Model and Process Companion documents into a single guidance document. It includes guidance for assessing the conformity of each process and includes an audit sequence, instructions for auditing each specific process, and identifies links that highlight the interactions between the processes.
In March 2012 the US FDA announced that they had approved a final pilot guidance document “Guidance for Industry, Third Parties and Food and Drug Administration Staff: Medical Device ISO 13485:2003 Voluntary Audit Report Submission Pilot Program.” This allowed the owner or operator of a medical device manufacturing facility to be removed from FDA’s routine inspection work plan for 1 year upon completing a ISO 13485:2003 audit. This guidance document went into effect in June 2012, and was intended as an interim measure while a single audit program was being developed.
This pilot program was not very successful and few companies signed up because they did not see any advantage in participating. The manufacturer had to pay for a third party to inspect their facilities, generate a report, and share the inspection results back to the FDA. Many companies were reluctant to contract “someone else” to perform their inspection when they could easily wait for the FDA to conduct an inspection for free.
During its inaugural meeting in Singapore in 2012, the International Medical Device Regulators Forum (IMDRF) appointed a working group to develop a set of documents for a harmonized third-party auditor system. Hence, the “Medical Device Single Audit Program” (MDSAP) was formed. The concept was similar to the FDA’s original idea of creating a third-party auditor to help reduce their workload of performing regulatory audits of medical device manufacturers’ quality management systems. This new approach would consist of a single audit that would review regulatory QMS compliance, conducted by a third-party, who would later be called an Auditing Organization (AO).
From January 2014 to December 2016, five countries participated in a Medical Device Single Audit Program Pilot. In June 2017, a report was generated summarizing the outcomes of prospective “proof- of-concept” criteria established to confirm the success of the program. The outcomes are documented in the final MDSAP Pilot Report and recommended that the program become fully active and open to any manufacturer who requested this type of audit.
The governing body of the MDSAP is the Regulatory Authority Council (RAC), which is composed of two senior managers (and a few other staff members) from each participating RA. They are responsible for executive planning, strategic priorities, setting policy, and making decisions on behalf of the MDSAP International Consortium. The RAC also reviews and approves documents, procedures, work instructions, and more. The mission of the MDSAP International Consortium is to jointly leverage regulatory resources to manage an efficient, effective, and sustainable single audit program focused on the oversight of medical device manufacturers on a global scale.
Other international partners that are involved in the MDSAP include:
MDSAP Observers:
- European Union (EU)
- United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA)
- The World Health Organization (WHO) Prequalification of In Vitro Diagnostics (IVDs) Program
MDSAP Affiliate Members:
- Argentina’s National Administration of Drugs, Foods and Medical Devices (ANMAT)
- Republic of Korea’s Ministry of Food and Drug Safety
- Singapore’s Health Sciences Authority (HSA)
The observers and affiliate members are not the same as the participating member RA’s. The observers simply observe and/or contribute to RAC activities. Affiliate members, on the other hand, are interested in engaging in the MDSAP program and are subject to certain rules. They are only given access to a certain level of information about the manufacturers, audit dates, and information in audit reports.
They are also invited to attend sessions that are open to members, observers, and affiliates only.
Audits can also be conducted by MDSAP participating RAs at any time and for various reasons including:
- "For Cause" due to information obtained by the regulatory authority
- as a follow up to findings from a previous audit
- to confirm the effective implementation of the MDSAP requirements
The purpose of audits conducted by the RAs is to ensure appropriate oversight of the AOs MDSAP auditing activities. The AOs are appointed by the RAs and a list of the currently approved AO’s is published on the FDA website. Most AOs offer a broad range of management system certification services, beyond just medical devices. Manufacturers should verify that prospective AOs are clearly trained and perform MDSAP audits of medical devices.
AOs have the final word as to whether a manufacturer has met the requirements for the MDSAP during the execution of the audit and generation of the associated reports summarizing the results. MSDAP RAC participating RAs have the final decision regarding all development, implementation, maintenance, and expansion activities associated with the program.
Although an unannounced visit by an AO is rare, it can happen in circumstances where high-grade nonconformities have been detected.
To continue reading this eBook including a detailed look at the MDSAP audit process and grading, pros and cons of the approach, and how to get started please register to download the full version.
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 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.
STED is dead
What is STED?
The STED, or Summary of Technical Documentation, format was created originally by the Global Harmonization Task Force (GHTF), the precursor to the current International Medical Device Regulators Forum (IMDRF). The original STED format, defined in 2007, was the first attempt to harmonize medical device submission information and standardize the information required under the EU MDD and regulations in other countries.
As medical devices and corresponding regulations developed more stringent regulations that defined their market access submissions, regulators found that this original harmonized format did not require sufficiently detailed technical information, nor did it provide enough structure. As a result, more recent regulations have replaced STED with expanded requirements. Note that some in the industry may refer to “STED” when discussing the newer requirements that have replaced it.
Is STED still valid?
Technical documentation formatted using STED may come close to meeting current requirements in some cases. However, many major markets have updated their regulations and requirements for technical documentation, or they have standardized on MDR. EU notified bodies expect MDR technical files, which may have specific requirements depending on the notified body that a manufacturer is using.
In addition to MDR in the EU, we have seen other countries over the past few years make changes to their regulatory systems and requirements, including:
- New regulations in China based on IMDRF in June, 2021 (Order #739)
- Emerging regulations in Canada and Brazil that are currently based on the IMDRF ToC
- New Regulations for Saudi Arabia that closely resemble EU MDR
- Massive regulatory restructuring in ASEAN market
What has replaced STED?
STED has been replaced by the IMDRF Table of Contents (ToC) submission dossier. This submission template has more defined requirements than STED and we are seeing countries update their regulations to adhere closely to the IMDRF ToC. There are a few additional benefits to the IMDRF ToC:
- Additional Flexibility - The IMDRF ToC has a specific numbering structure for technical requirements that allow authorities to “pick and choose” requirements based on submission type and risk classification.
- Efficiency – Countries that use the IMDRF ToC will have a matrix structure for their submissions to note what is required (R), Conditionally Required (CR), Not Required (NR) or optional (O). This can cut down on extraneous information that does not need to be in a submission. Canada already has draft guidance in place with their matrix submission style.
- Standardization – each country that follows the IMDRF ToC will number their submission document requirements with the same Table of Contents.
There are also other markets that are using alternative pathways to STED. The ASEAN market uses ASEAN CSDT (common submission dossier template), which is similar to the IMDRF ToC format, but uses different numbering. There are also two versions of the CSDT – one for standard medical devices and one for in vitro diagnostic devices.
Note that Singapore HSA has good information and is considered the “gold standard” for regulatory submission processes in the ASEAN market.
Expectations for future medical device submission requirements
We expect requirements to only get more complex and burdensome as countries move to further improve patient safety and address the needs of increasingly complex medical devices. A well-defined submission template strategy is critical to managing your device types. Within Rimsys, you can not only access standard IMDRF, NMPA, and other templates - you can design customized templates as needed for your holistic regulatory strategy.
Additional resources
Would you like to learn more about how Rimsys handles submission templates? Schedule a conversation with our experts now.
An overview of the UK Medicines and Healthcare Products Regulatory Agency (MHRA)
There’s no question that the medical device market is global, and the United Kingdom (England, Scotland, Wales, and Northern Ireland) is one of the world’s most viable and vital markets. It’s certainly one that you want your medical device in if you hope to make a global impact. The Medicines and Healthcare products Regulatory Agency (MHRA) is the gatekeeper of that market and one of the world’s most influential regulatory bodies.
Knowing who the MHRA is and understanding their role in ensuring that only safe, effective, high-quality medical devices enter the market is vital to your success in the UK. In this brief article, we’ll tell you more about who the MHRA is, their authority and responsibilities, and even some of the requirements you must meet to get your medical device into this market.
What is the MHRA?
The MHRA is an executive branch of the Department of Health and Social Care. It’s the UK’s equivalent of the US Food and Drug Administration (FDA), meaning that they set the quality and regulatory standards for medical devices in Great Britain.
Because the UK used to be part of the European Union, products required a CE marking to enter the UK market. Since Brexit, the MHRA has been the sole regulatory authority in Great Britain (England, Scotland, and Wales) and the gatekeeper to its robust medtech market.
What does the MHRA do?
As you know, medical devices must meet specific requirements before they can be sold in most markets around the world. Generally, the more developed the nation and its healthcare and medical device industries, the more complex its healthcare regulations are.
The MHRA is responsible for:
- Monitoring and regulating post-market surveillance of all medical devices currently on the market and creating regulations and requirements for medical devices entering the UK. They also enforce regulations, ensure medical devices meet the necessary safety, efficacy, and quality standards, and have the power to pull noncompliant products from the shelves.
- Making sure that supply chains for medical devices and the materials that comprise them are safe and secure. This includes everything from the facilities where products are made and stored, to their packaging and the systems and logistics applied in their transport.
- Educating the general public, healthcare professionals, and manufacturers about the risks and health benefits of medical devices.
- Engaging in harmonization efforts with other countries to develop standardized pathways to global markets. They influence international regulatory standards, best practices, and frameworks to support this effort.
How do you register a medical device with the MHRA?
Registering a medical device in the UK is different than in years past due to Brexit, which was the British exit from the European Union. Before Brexit, the UK adhered to the EU regulatory requirements as put forth in the EU MDD/IVDD, which Regulation EU 2017/745 (MDR) and Regulation EU 2017/746 (IVDR) eventually replaced. However, the MHRA will be instituting its new regulations currently set to be in force in July 2024.
One of the first steps of registering a product in the UK is getting the UK Conformity Assessment (UKCA) marking on your device and packaging. Manufacturers of Class I (lowest-risk classification) devices and general In Vitro diagnostic devices can self-certify against UKCA marking if these devices are non-measuring and non-sterile.
Class II and III devices must go through conformity assessment by a UK approved body. Approved bodies are the UK’s equivalent of Notified Bodies in the EU. These organizations have the authority to perform conformity assessments and apply UKCA markings on medical devices. UK approved bodies also perform post-market surveillance of devices currently on the market to ensure they’re safe and compliant for as long as they’re in use.
The process is a little different for device manufacturers outside of the UK who want to market their medical devices. Foreign manufacturers must designate a single person based in the UK to serve as their authorized representative (or UK Responsible Person). The UK Responsible Person acts as a liaison between the manufacturer and the relevant approved regulatory bodies, and handles the task of registering that company’s products with the MHRA.
The MHRA and Northern Ireland
When registering a device in Great Britain and Northern Ireland, you’ll notice that there are different procedures even though both were part of Brexit. According to the Northern Ireland Protocol (Northern Ireland’s response to Brexit), Northern Ireland applies Regulation EU 2017/745 (MDR) and Regulation EU 2017/746 (IVDR) to its own regulatory framework, whereas Great Britain has decided to implement its own regulations over the next couple of years.
For instance, as Northern Ireland still adheres closely to Regulation EU 2017/745 (MDR) and Regulation EU 2017/746 (IVDR), UK approved bodies cannot provide conformity assessments for them. In fact, if a manufacturer based in Great Britain wants to put a medical device on the market in Northern Ireland, they must designate an EU Authorized Representative to register the product for them.
Furthermore, an EU Notified Body must provide a conformity assessment according to Regulation EU 2017/745 (MDR) and Regulation EU 2017/746 (IVDR) for the device to receive UKNI marking (Northern Ireland’s conformity assessment mark). Likewise, Northern Ireland Authorized Representatives cannot represent Northern Irish or other foreign manufacturers in Great Britain, nor can Northern Ireland Notified Bodies provide UKCA marking for medical devices. In short, Northern Ireland has decided to continue to abide by EU medical device and in vitro diagnostics regulations as set forth by the European Medicines Agency, whereas Great Britain has not.
How to achieve compliance
The MHRA is firmly positioned as one of the foremost regulatory authorities in the world. They’re responsible for creating, implementing, and enforcing regulations for medical devices and IVDs in the UK while also providing research and education to promote the safety and efficacy of devices worldwide.
Adherence to UK regulations is essential to getting your medical device on that market and keeping it there. Medical devices entering the Great Britain market must adhere to the MDR/IVDR (until June 30, 2023) or UK MDR 2002, whereas Northern Ireland still abides by EU regulations.
Manufacturers based outside of Great Britain that want to put their devices on the market there must designate a UK Responsible Person (UKRP) to represent their interests and a UK-approved body to perform conformity assessments and apply UKCA marks. At the same time, Northern Ireland still adheres to EU regulations, requiring foreign manufacturers to utilize EU and NI responsible persons and notified bodies to assess medical devices, documentation, and manufacturing facilities while requiring the EU’s CE marking.
Bringing your device to market in the UK requires a dynamic regulatory strategy that enables you to optimize your projects and processes, ensuring your medical devices hit the mark for both the GB and NI markets. Also, it’s vital that you do your due diligence to ensure conformity with the regulations of both markets while also avoiding conflating their processes and regulatory requirements. Ultimately, getting your medical devices compliant with both markets could set your medtech company up to be a mainstay in the UK.
