Still Maintaining Duplicate MDD/IVDD- and MDR/IVDR-Compliant Documentation?
Your regulatory team is über-organized and has been maintaining duplicate sets of technical documentation for your legacy devices, in compliance with the old MDD 93/42/EEC and IVDD 98/79/EC and the new MDR 2017/745 and IVDR 2017/746. You’re doing this because even though your device has a valid CE Marking certificate that expires between 2023 and 2025, the MDR and IVDR are now the law of the land and you need to manage two sets of documents to maintain compliance with the MDD/IVDD and MDR/IVDR until your certs expire.
We have some good news for you: If you have created a set of MDR/IVDR-compliant documentation, you can move that other set into the virtual attic for long-term storage.
Why You No Longer Need MDD/IVDD Documentation
The short answer is that since May 26, 2021/2022, the MDD/IVDD no longer apply. But because you’re regulatory pros, we know you want more detail…
Here are some common (and understandable) beliefs about why a duplicate set of documentation must be maintained.
- Grandfathering. Legacy devices may hold onto existing MDD/IVDD certificates as long as no “significant” changes are made in accordance with Article 120 (MDR) or Article 110 (IVDR). However, there is no grandfathering of MDD/IVDD devices – all devices are required to comply with the MDR/IVDR right now. Many people are understandably confused by the “date of application” (May 26, 2021 or May 26, 2022) and the last date on which any MDD/IVDD certificate is valid (May 26, 2024 or May 26, 2025). Manufacturers wrongfully assume that during this soft transition period, two sets of documentation need to be maintained until their MDD/IVDD certificate expires. In reality, you should only maintain your MDR/IVDR-compliant documentation, even if you do not yet fully comply with the MDR/IVDR. Say what?! We’ll explain more below.
- Equivalency. Some companies have relied on “equivalency” claims to meet clinical requirements under the MDD/IVDD. However, the MDR/IVDR made equivalency claims next to impossible and, with this in mind – and because the MDR/IVDR is now in effect – some companies are maintaining two sets of clinical evaluation or performance reports, instructions for use, risk management files, and other documentation. To account for the fact they do not yet have the clinical data ready to support an MDR/IVDR submission, some companies no longer use data from equivalent / similar devices. They are updating contraindications, warnings, or cautions from their instructions for use and harms / hazards from the risk evaluation process because they believe the originals are no longer relevant since those came from the “equivalent devices.” However, MDCG 2020-5 guidance on clinical evaluation equivalence makes it clear that the data from similar devices can still be used in the clinical and performance process for ensuring that the risk management system is comprehensive by detecting related hazards and clinical risks among other things. Definitely get started commissioning clinical trials right away if your equivalence data will not be acceptable in the future.
From page 14 of the MDCG 2020-5 guidance:
“In cases where equivalence cannot be demonstrated under the MDR, the data from similar devices may be useful for a variety of other purposes, for example:
- Ensuring that the risk management system is comprehensive by identifying relevant hazards and clinical risks.
- Understanding the state of the art, the natural course of disease and alternative available treatment options.
- Helping to define the scope of the clinical evaluation, by identifying any design features in similar devices that pose special performance or safety concerns.
- Provide input for clinical investigation design or post-market clinical follow-up design, and the post-market surveillance system.
- Identification of relevant and specified clinical outcome parameters for the intended clinical benefits, based on the published clinical data pertaining to the similar device(s).
- To define minimum requirements for a quantified clinical benefit that is considered clinically relevant, and/or to identify acceptable occurrence rates of risks and adverse events.”
Don’t Kick the Can Down the Road
No doubt you have heard about the shortage of European Notified Body resources. If you have MDD certificates expiring in late 2023 or 2024 – or IVDD certificates expiring in late May 2026 – and plan to move those products over to the MDR/IVDR, you had better get on it now. According to May 2022 data compiled by Team NB (the European association of Notified Bodies), there is a tsunami of medical devices with certificates expiring in 2024. The problem is that the tsunami is far offshore and most people don’t know it’s coming – except you. Unless manufacturers plan to pull the majority of those devices off the market, it does not take a math genius to figure out that scheduling Notified Body MDR/IVDR audits for 2024 will be – shall we say – a bit challenging. Just so you don’t think we are fearmongering, even the European Commission thought it necessary to issue an unusual warning in June 2022, saying:
“Manufacturers should take into consideration that it might not be possible that notified bodies designated under the MDR would be able to assess all corresponding files within the first months of 2024. In this context, it is expected that the manufacturer has submitted an application to a notified body for certification in compliance with the MDR at least one year before the expiry date of the MDD/AIMDD certificate.” [emphasis added]
CE Certificates Expiring in 2023
CE Certificates Expiring in 2024
|Medical Device (MDD 93/42/EEC)||3,447||13,104|
|In Vitro Diagnostic (IVDD 98/79/EC)||219||655|
|Active Implantable (AIMDD 90/385/EEC)||52||304|
Also, it’s best not to assume that once you submit your technical documentation, all will be fine. Team NB notes, “At this stage, data collected by notified bodies, and presented to competent authorities in December 2021, shows that nearly 37% of manufacturers’ applications have been refused on the basis of incomplete applications, underlining an overall lack of manufacturers’ preparedness. In April 2022, 75% of notified bodies indicated that more than 50% of the submitted applications were deemed incomplete.”
Don’t Wait Until 2024
Don’t be among the hundreds of RA professionals who will go to their boss with their tail between their legs to explain that while they successfully milked their existing MDD/IVDD certificate as long as possible, they waited too long to get their ducks in a row and now they can’t get an MDR/IVDR audit scheduled until late 2024 or 2025. It’s probably best to start polishing your resume at that point.
Even though your device may still be lacking the clinical or performance data to support an MDR/IVDR submission, you can modify your quality plan or “strategy for regulatory compliance” document to outline the rationale and strategy for “sunsetting” older revisions of your CER/PER and other MDD/IVDD-related documents. You will use the appropriate information from those reports along with the postmarket clinical follow-up (PMCF) / postmarket performance follow-up (PMPF) plans and then initiate a new (current) version of those reports and not the old MDD/IVDD ones.
If you transition these documents to the MDR/IVDR, even before the product itself has been certified under the EU MDR/IVDR, this is a golden opportunity to have your Notified Body review those documents and provide early feedback. To help manufacturers, BSI published a position paper regarding implementation after the regulations come into force. On page 15 of the paper they reiterate the need to “[i]mplement new requirements for clinical evaluation” during the transition period and “[g]enerate clinical evidence to meet new requirements” after the date of application (DoA).
Since your device isn’t certified under the EU MDR or IVDR yet, you will need extra time as you remediate any feedback that you get from your Notified Body. It’s an easy way to get Notified Body feedback well before the tsunami approaches shore!
Want to Learn More?
Have a special situation and need some outside advice? The Oriel STAT A MATRIX consulting team is ready to help with advice on CERs/PERs, clinical data, risk management, or general MDR/IVDR compliance. Learn how we can assist. If your team needs to get up to speed on the requirements, consider our MDR or IVDR training courses, which can be delivered onsite at your facility or remotely.