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The beginner's guide to the FDA De Novo classification process
This article is an excerpt from The beginner's guide to the FDA De Novo classification process ebook.
Contents
- Introduction
- Chapter 1: What is an FDA De Novo request?
- Chapter 2: Contents of a De Novo request
- Chapter 3: Submitting a De Novo request
- Appendix A: Acceptance review checklist
Congratulations, you have successfully developed a new medical device! Now you need to take it to market. Normally in the United States this would mean completing a 510(k) submission. However, the 510(k) relies on “substantial equivalence”—a comparison to a similar device already on the market (also called a predicate device) to assess the risk profile of the new device. What if your device is totally new, and there isn’t a similar device to compare it to? Enter the FDA De Novo process. The De Novo process provides a pathway to market for novel devices with a low to medium risk profile.
What does De Novo mean?
According to the Merriman-Webster dictionary, de novo is a Latin word meaning “as if for the first time; or anew.” Perfectly fitting that the FDA uses this term “De Novo” to describe market approval requests for new medical devices or technology where there is no comparable predicate device on the market.
The Food and Drug Administration Modernization Act of 1996 provided the FDA with the authority to create the De Novo Classification Process. It's a process that uses a risk-based strategy for a new, novel kind of medical device, in vitro diagnostic, or medical software solution whose type has previously not been identified and/or classified. It’s a process by which a novel medical device can be classified as a Class I or Class II device, instead of being automatically classified as Class III, which may not be appropriate. Before the implementation of the De Novo process in 1997, all the “not substantially equivalent” (NSE) products were required to be initially classified as a Class III device. But for a lot of devices, this risk class didn’t really make sense. The De Novo process provides a pathway for more accurate classifications of novel, lower-risk devices.
October, 2021, the FDA released a final guidance document "De Novo Classification Process (Evaluation of Automatic Class III Designation)" to provide guidance to the requester (also known as the manufacturer) and the FDA on the process for the submission and review of a De Novo Classification Request under section 513(f)(2) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act). This process provides a pathway to an initial Class I or Class II risk classification for medical devices for which general controls or general and special controls, provide a reasonable assurance of safety and effectiveness, but for which there is no legally marketed predicate device. This guidance document replaced the "New Section 513(f)(2) – Evaluation of Automatic Class III Designation, Guidance for Industry and CDRH Staff" document, dated February 19, 1998.
Consistent with the final rule, the FDA updated the guidance documents below to provide recommendations for submitting De Novo requests, as well as criteria and procedures for accepting, withdrawing, reviewing, and making decisions on De Novo requests, effective January 3, 2022.
- User Fees and Refunds for De Novo Classification Requests
- FDA and Industry Actions on De Novo Classification Requests: Effect on FDA Review clock and Goals
- Acceptance Review for De Novo Classification Requests
The 510(k) and the De Novo processes are similar in that they are both pathways to market for medical devices with low to moderate risk, which is Class I and Class II. The biggest difference between the two is that the 510(k) heavily relies on the concept of "substantial equivalence" to an existing medical device. You must prove this to get the clearance of your 510(k) submission. In the De Novo process, there isn’t a product currently on the market that is “substantially equivalent” to yours, so it’s like starting with a clean slate. For more on the 510(k) process, see our Beginner’s Guide to the 510(k) ebook.
A result of the De Novo process to be aware of is that a successful submission will lead to a new predicate device type that someone else can reference to bring their product to market through the 510(k) process. You’ve done all the work, so now it’s available for anyone to use to provide "substantial equivalence".
De Novo history/timeline
Preparing a De Novo request
1. Do your research! Be sure to complete all the necessary research prior to your submission. You want to be sure that your device is not substantially equivalent to an existing device. Resources to review include:
- The Center for Devices and Radiological Health (CDRH)
- U.S. FDA Device Classification Database
- Device Classification Under Section 513(f)(2)(De Novo)
2. A De Novo request can be submitted with or without a preceding 510(k). There are two options for when you can submit a De Novo request:
Option A: After receiving a not substantially equivalent (NSE) determination (that is, no predicate, new intended use, or different technological characteristics that raise different questions of safety and effectiveness) in response to a 510(k) submission.
Option B: If you’ve determined, after extensive research, that there is no legally marketed device on which to base a determination of substantial equivalence.
3. Be sure all fees are paid to the FDA in advance of submitting a De Novo request. The FDA’s fiscal year begins in October and runs through the following September. Fees have increased each year since they were introduced, but the FDA’s percentage of reviews completed within the 150-day window has increased as well.
A business that is qualified and certified as a “small business” is eligible for a substantial reduction in most of the FDA user fees, including De Novo. The CDRH is responsible for the Small Business Program that determines whether a business is qualified.
Medical Device User Fee Amendments (MDUFA) guidance documents can provide more detailed information about all FDA user fees.
4. The initial request process serves only to determine if the De Novo request is administratively acceptable based upon the Acceptance Checklist. The initial acceptance is followed by substantive review which will determine the final risk classification of your device.
5. A Pre-Submission (Pre-Sub) is a formal written request for feedback from the FDA that is provided in formal written form, and then followed by a meeting. Although a Pre-Sub is not required prior to a De Novo request, it can be extremely helpful to receive early feedback, especially for devices that have not previously been reviewed under a 510(k). If you think you would like to submit a pre-sub first, there are suggested guidelines for submission you should consider:
- Describe your rationale for a Class I or Class II classification for your device.
- Provide the search results of FDA public databases and other resources used to determine that no legally marketed device and no classification for the same device type exists.
- Provide a list of regulations and/or product codes that may be relevant.
- Provide a rationale for why the subject device does not fit within and/or is different from any identified classification regulations, based on available information.
- Identify each health risk associated with the device and the reason for each risk.
- Briefly describe any ongoing and/or planned protocols/studies that need to be completed in order to collect the necessary data to establish the device’s risk profile.
- Provide information regarding the safety and effectiveness of the device. Cite the types of valid scientific evidence you anticipate providing in your De Novo request, including types of data/studies relating to the device’s safety and effectiveness.
- Briefly describe any ongoing and/or planned protocols/studies that need to be completed to collect the necessary safety and effectiveness data.
- Provide protocols for non-clinical and clinical studies (if applicable), including how they will address the risks you anticipate and targeted performance levels that will demonstrate that general controls or general and special controls are sufficient to provide reasonable assurance of safety and effectiveness.
- Share any proposed mitigation measure(s)/control(s) for each risk, based on the best available information at the time of the submission. Highlight which mitigations are general controls and which are special controls and provide details on each.
- Include any other risks that may be applicable, in addition to those identified in the Pre-Sub, given the indications for use for the device.
- If applicable, provide any controls that should be considered to provide a reasonable assurance of safety and effectiveness for the device.
- Provide any non-clinical study protocols that are sufficient to allow the collection of data from which conclusions about device safety and/or effectiveness can be drawn. These protocols should address whether the identified level of concern is the appropriate level of concern for the device software, and if any additional biocompatibility and/or sterility testing is required.
- If clinical data is needed, provide information to show that the proposed study design and selected control groups are appropriate?
6. The FDA will attempt to review the De Novo request submission within 15 calendar days of receipt of the request to make a determination that the submission is declined or accepted for review. If they are unable to complete the review within the 15 days, your submission will automatically move to “accepted for review” status. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/de-novo-classification-process-evaluation-automatic-class-iii-designation
7. There are times when the FDA will refund your application fee. They have created a guidance document “User Fees and Refunds for De Novo Classification Requests” for the purpose of identifying:
- the types of De Novo requests subject to user fees
- exceptions to user fees
- the actions that may result in refunds of user fees that have been paid
When is a De Novo request subject to a user fee?
When will the FDA refund a De Novo user fee?
What fee must be paid for a new device submission following a De Novo “decline” determination?
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.
Brexit overview for medical device manufacturers
What is Brexit?
Brexit - meaning "British exit" is the process of the official withdrawal of the United Kingdom (UK) from the European Union (EU) on January 31, 2020, at 11:00 PM (GMT). The UK had been a member state of the EU since January 1, 1973, when it was known as the European Communities.
Leaving the EU was no easy task for the UK and it was six years in the making before it was final. When they “left” in January 2020, a discussion and negotiation transition period with the EU began. The negotiation process was both politically challenging and deeply isolating. Under the UK Prime Minister, Boris Johnson, the country continued to participate in many EU institutions during the one-year transition period in order to ensure frictionless trade until a long-term relationship could be agreed upon. Trade deal negotiations continued up until just days before the scheduled end of the transition period (December 31, 2020) and the EU–UK Trade and Cooperation Agreement was signed on December 30, 2020.
Following Brexit, EU law and the Court of Justice of the European Union no longer have power over British citizens and companies, with the exception of select areas related to Northern Ireland. Under the terms of the Brexit withdrawal agreement, Northern Ireland continues to participate in the European Single Market in relation to goods and to be a de facto member of the EU Customs Union.
The European Union Referendum Act 2015 set the wheels in motion. This Act of the Parliament of the United Kingdom made a legal provision for a referendum to be held on whether it should remain a member state of the European Union or leave it completely. The related legislation was introduced to the House of Commons in May of 2015, and it was passed on its third review in the House of Commons in early September 2015 and approved by the House of Lords in December 2015. The Act went into full legal force on February 1, 2016.
The initial withdrawal in March 2019 was delayed by the deadlock in the British parliament after the June 2017 general election. This deadlock then led to three extensions of the UK’s Article 50 of the Treaty of European Union (TEU), which began the member states’ withdrawal, known as Brexit.
Brexit’s effect on medical device regulations
All medical devices, including IVDs, custom-made devices, and systems or procedure packs must be registered with the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) before they can be placed on the UK market. The MHRA is developing a new regulatory framework for medical devices, designed to safeguard and advance the health of its people by enabling early access to a high-quality supply of safe, effective, and innovative medical products. CE marked devices will initially be recognized in the UK, but manufacturers will have to obtain UK Conformity Assessment (UKCA) certification and follow the marking requirements per UK MDR 2002, beginning July 1, 2023. CE-marked devices will be allowed in the UK market until June 30, 2023, as long as they have been CE marked under one of the following:
- Directive 90/385/EEC - active implantable medical devices
- Directive 93/42/EEC
- Directive 98/79/EC - in vitro diagnostic medical devices
- Regulation 2017/745
- Regulation 2017/746
Medical device manufacturers continue to be able to self-certify CE marked devices until June 30, 2023 - providing the certificates remain valid for the EU market under the transitional timelines listed in the EU MDR and IVDR.
From January 1, 2022, non-UK manufacturers will require a UK Responsible Person for the purposes of registering devices. A Northern Ireland-based Authorized Representative will no longer be able to register devices on a manufacturer’s behalf for Great Britain.
You will need to use the new UKCA marking before January 1, 2023, if your product:
- will be marketed in Great Britain, and
- is covered by legislation that requires the UKCA marking, and
- requires mandatory third-party conformity assessment, and
- conformity assessment has been carried out by a UK conformity assessment body.
This does not apply to existing stock if your goods were fully manufactured, CE marked, and placed on the market before January 1, 2021.
Northern Ireland – the rules are different
In some circumstances, it is a requirement of the UK MDR 2002 that you inform the MHRA when you first place your device on the Northern Ireland market. Under the Northern Ireland Protocol, different rules apply than those in Great Britain. The precise requirements depend on the location of the manufacturer, the location of the Authorized Representative, and the device class. For more information on the regulatory system for medical devices in Northern Ireland, refer to the Regulation of medical devices in Northern Ireland.
The future of medical device regulations under Brexit
As you can see, the rules have changed and may continue to be refined until June 30, 2023. Currently, the CE marking is only valid in the UK for areas where both UK and EU rules remain the same. The UKCA marking is not recognized in the EU market, therefore, products will need the CE marking to sell in the EU. The UK MDR 2002 is up to date with all changes known to be in force on or before June 28, 2022. However, there may be changes that will be brought into force at a future date.
For more information on the EU MDR and IVDR requirements, read our Ultimate guide to the EU MDR/IVDR unique device identifier (UDI) system and Ultimate guide to the EU MDR GSPR - general safety and performance requirements.
The RegUP rundown
What is a RegUP?
The medical device industry is, by its very nature, a high-stress one. New medical technologies are being created all the time, and as a result, regulations are constantly changing. Being a regulatory professional in the medtech industry requires extraordinary attention to detail and nerves of steel. Rimsys was founded by regulatory pros for regulatory pros, and we understand the need to unwind in a professional environment with other leaders in the industry. That’s why we came up with the idea of the RegUP.
So, what’s a RegUP? It’s short for “Regulatory Meetup,” and it’s a small gathering of regulatory professionals, not a large conference. We’ll enjoy delicious food and beverages as we get to know each other and discuss regulatory trends and best practices.
When and where?
Boston - Sept 29th
Our first RegUP event will be held on the East Coast in Boston, MA, on September 29, 2022, at Democracy Brewing. Democracy Brewing, nestled in historic Downtown Crossing (one of the oldest neighborhoods in the United States), is the first cooperative brewery in Boston. Their menu features plenty of delicious craft beers and an eclectic selection of cuisines ranging from Mediterranean to classic American bar food.
San Jose - Oct 13th
Our second event will be held on the West Coast in the San Jose area on Oct 13, 2022, at Big Dog Vineyards. Big Dog Vineyards is a locally owned and operated winery in the picturesque Milpitas Hills, CA. Their Winery & Tasting Room opened in 2009, right beside the estate vineyard, which was planted in 1997.
What should you expect at a RegUP event?
As mentioned, we understand that regulatory professionals in the medical device industry are under constant pressure to ensure they keep up with ever-changing trends and best practices. And if you are like us, the opportunity to hone your trade and sharpen your skills and knowledge in a more casual setting will be welcome.
Here’s the agenda for RegUP Boston to give you an idea of what to expect at our events:
- 12:00 - 12:30 pm Welcome: Increasing confidence in regulatory planning. Many regulatory challenges are driven by a lack of visibility into regulatory timelines, resources, and needs. A comprehensive regulatory data strategy can help RA teams build more resilient plans, and shift their organizational posture from reactive to proactive.
- 12:30 - 1:15 pm Catered lunch
- 1:15 - 1:45 pm TBD Regulatory best practices case study
- 1:45 - 2:15 MDR/IVDR information essentials: MDR/IVDR compliance remains top of mind for RA teams. New information requirements including GSPRs, UDI/EUDAMED, and Post-market surveillance and reporting require a new approach to regulatory information management.
- 2:15 - 4:00 pm Brewery tour, tasting, and networking
Rimsys Speakers
- James Gianoutsos - Founder & CEO
- Bruce McKean - Director of Regulatory (Boston)
- Adam Price - Director of Product, Post Market (San Jose)
We hope to see you there!
Our RegUP events in Boston and San Jose will be the first of many opportunities for us to network, further regulatory knowledge and processes, and even enjoy each other’s company over tasty beverages. Best of all, these events are free for Rimsys customers and qualified guests.
Of course, you can also expect these events to get bigger and better with time. Nonetheless, you don’t want to miss out on the first of these opportunities to get to know us and our industry better. We hope to see you there! If you are unable to attend though, keep an eye on our LinkedIn page for future RegUP events in a city near you.
To get more information and register for our upcoming events, click the links below:
- RegUP Boston: https://regup-boston.eventbrite.com/
- RegUP San Jose: https://regup-sanjose.eventbrite.com/
IVDR: In Vitro Diagnostic Regulation within the European Union
What is the IVDR In Vitro Diagnostic Regulation?
The European Union’s In Vitro Diagnostic Regulation (IVDR) 2017/746 applies to IVD devices and came into force on May 26, 2022. The IVDR is a major change over the In Vitro Diagnostic Directive (IVDD), which it supersedes. The new regulation is designed to better protect patients and address changes in IVD technology through new requirements and stricter controls. As a Regulation, unlike a Directive, the IVDR becomes a requirement in every EU country on the same day, which means that compliance with the IVDR is paramount for market access within the EU.
Major changes in the IVDR
The IVDR includes changes to IVD classification, increased documentation requirements, and UDI specifications. It is critical for manufacturers and their European representatives to understand and implement the new regulations as soon as possible. There is significant concern that notified bodies will not have sufficient resources to handle the increased need for their services.
The major changes between the IVDR and its predecessor, IVDD, are as follows:
Changes to the classification system
Under the IVDD only a small percentage of IVD products were assigned a higher risk classification (based on a predefined list of products). All other products were exempt from notified body oversight and allowed for manufacturers to self-certify through conformity procedures. Under the IVDD, only 10%-20% of IVD products were subject to notified body oversight, whereas, under the IVDR, 80%-90% of IVD products will be subjected to notified body oversight.
Unlike the IVDD, the IVDR defines 4 risk classes based on risk profile:
- Class A: Lowest risk (e.g. specimen containers)
- Class B: Low to moderate risk (e.g. pregnancy tests)
- Class C: Moderate to high risk (e.g. cancer screening products)
- Class D: High risk (e.g. HIV tests)
It is important that IVD manufacturers re-classify their products using the new classification rules as soon as possible. Notified body oversight is required for IVDs in class B through class D.
Increased technical documentation requirements
Under the IVDD, technical documentation requirements were vague and left largely to the discretion of the manufacturer. The IVDR, however, details specific requirements for the content of technical documentation. Annex I details the General Safety and Performance Requirements, Annex II details primary technical documentation requirements, and Annex III details requirements for technical documentation for post-market surveillance.
Unique Device Identification (UDI) requirements
IVDs now require UDI labeling and registration in the European Union Database of Medical Devices, more commonly known as EUDAMED, in the same way as other medical devices. A UDI must be assigned to all medical devices, with some exceptions for custom-made and investigational devices.
Each UDI consists of multiple elements, including a Basic UDI-DI (also known as “BUDI”), a device identifier (DI) with static device information, and a product identifier (PI) with dynamic information provided by the manufacturer (such as serial number and manufacturing date). In addition, manufacturers can now register their device in EUDAMED, though this is not yet required.
Quality management system requirements
All IVD manufacturers are expected to have a quality management system in place, even though only those manufacturing class B to D devices require certification of conformity assessments by a notified body.
Person Responsible for Regulatory Compliance (PRRC)
Manufacturers will now be required to designate at least one person to monitor compliance with regulatory requirements. A PRRC must be qualified by way of a relevant degree and a minimum of one year of professional experience, or at least 4 years of experience in medical device regulatory affairs or quality management. Note that smaller manufacturers do have the option to subcontract their PRRC functions, but one person cannot act as a PRRC for a manufacturer based outside of the EU and for an Authorized Representative.
IVDR deadlines
Manufacturers who were able to self-declare conformity under the IVDD, but require a notified body under IVDR may continue to place IVDs on the market assuming they had issued a declaration of conformity prior to the original May 26, 2022 deadline, introduce no significant changes to the product, meet all post-market surveillance and vigilance requirements, and register in EUDAMED as specified in the IVDR. Assuming that these requirements are met, the new transition dates are as follows:
- May 26, 2022 - All new devices and non-sterile self-declared devices
- May 26, 2025 - Class D devices
- May 26, 2026 - Class C devices
- May 26, 2027 - Class B devices and Class A sterile devices
IVD regulations outside of the EU
This article is specific to requirements in the EU. It is important to note that other countries, such as the United States, have their own regulations related to In Vitro Diagnostics that are covered by the country’s medical device regulations. Each country with medical device regulations has its own classification scheme that may cause your device to be regulated in a different way. During the initial phase of planning for global commercialization of a product and throughout the product life cycle, it is imperative that you consider international regulations, their classification schemes, and the registrations that each country will require.
For additional information, The ultimate guide to EU MDR and IVDR general safety and performance requirements and also The Ultimate Guide to EU MDR/IVDR UDI.
CE marking guide for medical devices in the European Union
This article is an excerpt from the CE marking guide for medical devices in the European Union.
Table of Contents
- What is CE marking?
- Why is CE marking important?
- CE marking responsibilities
- What countries require or accept CE marking?
- Which medical devices require a CE mark?
- Technical documentation
- What are the costs associated with CE marking?
- How do you apply the CE marking?
- CE mark and UDI
- Does the CE mark expire?
- Do I need to CE mark my software?
- Final steps
CE marking is a symbol that consists of “CE, “ which is the abbreviation of the French phrase "Conformité Européene" meaning "European Conformity". The term initially used to describe “CE” was "EC Mark" but it has officially been replaced by "CE marking" according to the EU Directive 93/68/EEC. CE marking is used in all EU official documents, although you will still see "EC Mark" being used in common language. If you are using EC Mark in your documentation, you should change that terminology to CE marking in the future.
The letters ‘CE’ appear on many products traded on the Single Market in all the member states of the European Union plus Iceland, Liechtenstein, Norway and Switzerland. Simply put, The CE mark is a mandatory compliance mark, informing the consumer that the product is compliant with all applicable EU directives and regulations where the CE mark is required.
The Single Market was established in 1993 and is still considered one of the most significant achievements of the European Union. The main goal was to ensure the movement of goods and services freely within all the member states and to establish high safety standards for consumers. The CE mark indicates that goods and services do not need to be verified when shipping into another member country. To further support this movement, in April 2011, the Single Market Act was established to boost growth and strengthen confidence in the economy even further.
CE marking is required for many types of products, not just medical devices. The CE symbol can be found on bicycle helmets, toys, laptop batteries, wheelchairs, construction equipment, gas appliances and cell phone chargers - to name a few. CE marking is required for products manufactured anywhere that are sold in the EU, and only for those products for which EU specifications exist and require CE marking. The CE marking signifies that the product has been found to meet the general safety and performance requirements (GSPRs) of the European health, safety and environmental protection legislation and allows the product to be sold in the EU.
Manufacturer responsibilities for CE marking
Medical device manufacturers are responsible for properly and legally CE marking products before they leave the warehouse.
Most Class II and III medical devices, along with IVDs and some Class I devices, require a conformity assessment performed by a Notified Body to ensure that all legislative requirements are met before it can be placed on the market. Manufacturers of most Class I devices can self assess conformity. This process needs to demonstrate that all the legislative requirements are met, including any testing and inspections, and that all necessary certifications are obtained.
The European Commission lists 6 steps that manufactures should follow to affix a CE marking to their devices:
- Identify the applicable directive(s) and harmonized standards - see EU standards for Medical Devices, In Vitro Diagnostic (IVD) devices, and Implantable Medical Devices.
- Verify product specific requirements using the essential principles identified in the above standards.
- Identify whether an independent conformity assessment by a Notified Body is necessary. Notified bodies will be required to verify compliance with relevant Essential Requirements for most medical devices classified as IIa, IIb, or III - along with sterile class I devices. See the Notified and Designated Organization (NANDO) database for available notified bodies.
- Test the product and check its conformity.
- Create and keep available the required technical documentation.
- Affix the CE marking and create the EU Declaration of Conformity.
Importer responsibilities for CE marking
If you are importing medical devices into the EU, it is your responsibility to review all the technical documentation and maintain a copy, or to make sure that it’s available to you upon request.
You should verify:
- That the device has been CE marked and that the EU declaration of conformity has been completed.
- That the manufacturer has designated and established an authorized representative.
- That the device is labeled appropriately and contains instructions for use (IFU).
- When applicable, that a UDI has been assigned to the product.
- Whether or not the product is registered in EUDAMED (registration is currently voluntary).
Take action:
- List your name and address on the device or packaging, in addition to the manufacturer’s information.
- Keep records of complaints, non-conformities, recalls, etc. on file.
- Report any noticed non-conformity or product complaints from end users to the manufacturer and authorized representative immediately.
- Maintain a copy of the EU declaration of conformity and any other relevant certificates.
Distributor responsibilities for CE marking
If you are a distributor, you are responsible for reviewing the technical documentation provided to you so that you can verify the product is safe to put on the local market. You must also be sure the product is labeled correctly with the CE marking symbol clearly visible. The technical file documentation contains all of the information that is necessary to show conformity of the product to the applicable requirements.
You should verify:
- That the device has been CE marked and that the EU declaration of conformity has been completed.
- That the device includes all the appropriate labeling, including instructions for use.
- That if imported, the importer has complied with all the EU regulations.
- When applicable, that a UDI has been assigned to the product.
Take action:
- Report any noticed non-conformity to the manufacturer, importer, and authorized representative immediately.
- If a product appears to be out of compliance to the regulations and could pose a serious risk, the information should be reported to the Competent Authority, and to the manufacturer, importer and authorized representative.
- Any complaints or reports from end users about the product should be reported to the manufacturer and, if necessary, to the importer and authorized representative.
Important note: If the importer or distributor markets the product under their own company name, then they become responsible for CE marketing, and take over that role from the manufacturer.
CE marking is mandatory when importing products into the European Union, which is part of the larger European Economic Area (EEA). The EEA Agreement, established in 1992 and made official in 1994, is an international agreement that enables the extension of the European Union’s single market to non-EU members. It consists of the 27 EU countries plus the four European Free Trade Association (EFTA) countries - Iceland, Liechtenstein, Norway and Switzerland. Today, the EFTA has 29 Free Trade Agreements (FTAs) with 40 countries and territories outside the EU. Because these countries operate in the single market, this allows free movement of goods and services across all of the EEA.
Source: European Environment Agency (EEA).
All medical devices sold in the EU require a CE mark. While a CE mark is not required for items such as chemicals and pharmaceuticals, it can be required for combination devices and medical device software. For these two situations, how do you know if your product requires a CE mark?
To continue reading this ebook, including an overview of CE mark costs, and the associated technical documentation/general safety and performance requirements (GSPRs) that manufacturers are required to maintain please register to download the full version
Ask us Anything ... about UDI!
Your UDI questions answered
Our first “Ask us Anything” webinar last week focused on the topic of Unique Device Identification (UDI). We had so many great questions that we couldn’t answer them all during the session! We have picked the most common questions and put them together here with the answers from our expert panel.
For additional information on this topic, see the following resources:
- Quick reference guide - global medical device UDI requirements and timelines
- BUDI-DI - Basic UDI explained
- The ultimate guide to the EU MDR/IVDR unique device identifier (UDI) system
- Watch a replay of the Ask us Anything about UDI webinar!
Q: I’ve heard that the EUDAMED timeline has been pushed back. Is that true?
Yes, that is true. The European Commission recently pushed back EUDAMED deadlines by one year. It is important to note that this does not affect UDI labeling requirements and timeframes, only the mandatory entry of UDI data attributes into EUDAMED (now Q2 2026). The industry should not relax their efforts in regards to collecting and submitting UDI data. We make every effort to keep our Quick reference guide: global UDI requirements and timelines up-to-date and deadlines and regulations change.
Q: Are we expecting the FDA to be actively enforcing UDI regulations against class I manufacturers after September 2022?
Following this session, the FDA announced that they do not intend to enforce GUDID submission requirements for class I and unclassified devices, other than implantable, life-supporting, or life-sustaining devices.
Q. What governing body controls the correctness of GUDID data?
While the manufacturer is responsible for the accuracy of data they input into GUDID, the FDA is the agency that oversees the requirements.
Q: I have a UDI for a software device (SaMD) that includes features that will be included in a clinical study and features that will be part of the commercialized release version. Do I need to have separate UDIs or can I add the IDE label under a single UDI for the clinical version and keep the UDI for the market released version?
To fully answer this question, we might need a little more information. However, if the device involved in the clinical study is not released (i.e. marketed), then it would not require a UDI. If additional features are introduced during the clinical trial and a new product is released as a result, then a new UDI would be required.
Q: Can you provide insight into machine-to-machine transmission of UDI information?
Currently, the U.S. UDI database, GUDID, has the capability to accept machine-to-machine data transmission. More information can be found on the FDA website here. Most other major markets are working on providing this capability.
Q: How do I make a UDI implementation plan for the QMS process? What things need to be covered?
This is a broad question and there could be many different answers based on your product, QMS, and company structure. Generally speaking:
- UDI should be integrated within your Design Controls/Development processes, including the company product release process. You cannot market your device into a country without complying with their UDI requirements. Some countries require UDI information as part of the device registration process (e.g., EU and China).
- The company needs to establish accounts with the Issuing Agency (e.g., GS1) and with the country UDI databases (e.g., U.S. FDA GUDID)
Main things to consider:
- Labeling: Barcoding software and a process for creating the labeling
- Product UDI data attributes: All product related characteristics that are required to be recoded in the country UDI database. The specific characteristics/attributes can be found in the various country UDI guidance documents.
- Define methods for capturing, storing, controlling, transmitting data attributes (e.g., a RIM system, PLM system or both).
- Establish processes for maintaining the data including the country requirements (timeframes) for updates to the UDI data and periodic audits (reference country UDI guidance documents).
Q: How do I know what UDI information needs to be supplied to regulators?
The FDA regulations and data dictionary are mature and include information and required data fields to complete successful transmission of data. Data field details include information on whether data is required or conditional on other data, lists of standardized values, and guidance on the data that is expected for each field. EUDAMED has taken a similar approach, and also includes information that is expected for BUDI. The EUDAMED data dictionary is still in flux. We expect a similar approach from other countries.
Q: When you are implementing UDI and have a kit or system pack, do you need to have a separate UDI for the device, accessories for that device, and a separate UDI for the kit (which would have those components)?
Generally, the UDI is assigned at the lowest sellable product level. In the case of kits, procedure packs, or systems - each would be given a unique UDI as well.
Q: Is the GUDID barcode and the UDI barcode on the product label the same?
There is no GUDID barcode, but the information on the UDI barcode is contained within the GUDID database. The barcode or human-readable numbers provide high level information about the device. They act as an access key to all of the device attribute data within the GUDID database. The expected barcode on the product is the full UDI including the device identifier (DI) and the production identifier (PI). The GUDID is the FDAs regulatory database where labelers are required to submit information about the UDI DI.
Oh No! How to recover lost medical device certificates
Imagine that you have started working in a new position at a medtech company, and you’re trying to organize your current knowledge of the products, registrations, and information now under your charge. However, something feels off, and you realize that you cannot find all of your company’s current medical device certificates.
Lost medical device certificates are a more frequent occurrence in our industry. In fact, it’s my experience with the frustration of recovering lost medical device certificates that finds me writing this brief post about what it’s like to lose a medical device certificate and the strategies I’ve used to recover the lost information. We’ll even discuss what you can do to prevent having to live “The Tales of the Lost Document” in the future.
How do certificates get lost?
The most common factor in misplaced or lost certificates is human error stemming from lax filing systems with disjointed practices and team member departures. Many large medtech companies have a complex structure of emails and document storage sites (such as Sharepoint or Dropbox). These storage sites are often siloed, with different regulatory teams having varying excel spreadsheets, folder structures, and naming conventions to organize their regulatory submission workload.
In many companies, managing global medical device certificate information is a manual and burdensome process. The problem could be as simple as a file-naming mixup, or it could be a document your company hasn’t needed the certificate in so long that they simply lost track of it. Now let's talk about ways you can recover your lost certificates or information that’s missing from them.
How can you recover lost certificates?
The good news is that you can recover your lost documents in many cases, though it may take a bit of legwork. There are two primary strategies for finding lost medical device certificate information, and utilizing both is the best way to ensure you recover your lost certificates and information.
The first and often most successful pathway is to search through your internal resources.
Strategies for Searching through internal resources:
- Have you found every Sharepoint site used in the past five years?
- Have you checked previously recorded submissions of that medical device?
- Have you contacted IT to see if they can recover emails from a departed colleague? They might have sent emails with the certificate attached to them. Many regulatory professionals email a copy of the certificate to announce to the marketing teams they can begin product sales.
- Are you working with a distributor? Contact them and request knowledge on all of the current medical device certificates.
Other channels are available if you can’t find what you’re looking for in your company’s local storage.
The second strategy is to use governmental medical device registration databases. For example, if you’re registration information for a class 2 medical device, you could look it up in the FDA 510(k) database. Here are some examples of the international regulatory databases that may help in your situation:
United States - FDA
Canada - Health Canada
European Union
Australia
Belgium
Brazil - ANVISA
Singapore - Health Sciences Authority
Saudi Arabia - SFDA
If you are looking for a certificate that was approved by a notified body and not in a current database, you can contact the notified body, but you should expect to pay a fee for their services. It’s also important to note that not all countries and regulatory bodies have a database that allows companies to look up their certificates.
You may also have to accept that you can’t recover your medical device certificate or information. Not every country has a medical device database, and even those with a database often don’t contain the certificate itself. That’s why it’s critical to the efficacy of your RA operations that your team has the tools necessary to store, track, and share regulatory information and documents securely and efficiently.
How do you make sure this never happens again?
We understand that trying to find missing certificates is an administratively heavy burden. When you can’t find a certificate or its missing information, there’s no way to tell whether it’s lost forever until you’ve exhausted all possibilities and channels, which is why it’s much better to prevent losing documents altogether.
With the right tools, your RA team can store, locate, and share documents in a secure and largely automated environment. That means no more awkward conversations where you have to tell your boss you can’t find the expiring certificate for your company’s flagship medical device.
Rimsys is regulatory information management (RIM) software created by RA professionals from the medtech industry with RA professionals in mind. It empowers RA teams to store and track all certificates by product and country and even provides a portal where you can see all of your regulatory documents in a centralized view. Furthermore, you’ll receive emails when a certificate is about to expire, allowing you to act in ample time to prevent lapses in compliance and continue market access per your company’s global device strategy.
Learn more about how a RIM system can help your organization keep track of all its regulatory information in our “RIM Buyer’s Guide.”
