We have previously talked about the upcoming 2024 EU deadlines for QMS compliance and notified body applications for the EU MDR 2017/745 (5 Essential Tips for EU MDR Compliance and How to Meet the EU's 2024 MDR Deadlines), but what is needed beyond that?
What if you have your contract in place with a notified body and your technical documentation is ready for assessment now? There are varying lead times at each of the notified bodies; these times depend on the notified body and the applicable codes for your product. Realistically, the actual conformity assessment may not start for another 18 months, but your technical documentation has sat in a queue for some time waiting for the review to start.
What should you do in the interim?
When you submitted your technical documentation, all the documents were shiny and new, but by the time the conformity assessment has started – a year or two may have passed – and suddenly your notified body is asking for updated risk documents, the latest post-market surveillance (PMS) reports, updated clinical evaluation reports (CER), reviews of updates to the latest standards, and so on. What should you do?
Here are 5 tips on how to be effective while waiting.
1. Don't stand still
Act like you already have your CE certificate.
- Run your processes to generate the evidence to demonstrate that your process outputs support your MDR compliance efforts (e.g. evidence that shows how your PRRC is actively fulfilling their duties as described in Article 15 of MDR 2017/745 and MDCG 2019-7, such as ensuring that the technical documentation is kept up-to-date and that post-market surveillance activities are implemented effectively).
- Execute your PMS and post-market clinical follow-up (PMCF) plans, including keeping your finger on the pulse of the changes in the generally acknowledged state of the art. This includes ensuring that new MDCG guidance is not overlooked; assessing changes to regulatory and/or product requirements; ensuring that new and updated standards are considered and reviewed for applicability, and where applicable their impact on your product, processes or data is understood. Produce your Periodic Safety Update Reports (PSURs) as defined in your PMS plans, at the required frequency for the device classification.
- Ensure that your feedback loops for post-market data are working; remember, the post-market surveillance requirements have been applicable since May 2021., Use the outputs from your PMS process to update your Clinical Evaluation Reports (CERs) and risk management files as necessary to ensure that your benefit-risk determination is being reviewed and updated.
- Update your technical documentation and all supporting documents as is needed to demonstrate conformity with the requirements of the MDR.
If you are making non-significant changes to your legacy device and your legacy device is transitioning to MDR CE certification, you will need to reflect those changes in your Technical Documentation to ensure that the MDR certification review is conducted on contemporaneous evidence.
2. Evidence of validity
As discussed in our 5 Essential Tips for EU MDR Compliance, don’t forget to utilize the self-declarations and notified body declarations to confirm that your certificates and legacy devices meet the conditions laid out in Regulation (EU) 2023/607 so that you can demonstrate to your customers that your legacy devices can still be placed on the market legally. These declarations may need to be maintained as key information and statements contained within changes.
3. Keep your eyes and ears open
As more and more devices go through certification, more feedback is available. This includes insights on the types of questions being asked, the depth of analysis or justification that is being deemed acceptable by the Notified Body reviewers and the expected (and accepted) content for documents such as the Summary of Safety and Performance (SSCP). Keep tabs on webinars, bulletins and whitepapers from the Notified Bodies, and updated guidance or papers from Team-NB. These will all help you gauge the current expectation levels and be ready to answer questions/requests once the review starts.
4. Have data, will upload
Further delays to the dates for mandatory use of EUDAMED have just been announced, with 2027 now looking like the new date for mandatory use of most modules. Ignore EUDAMED uploads at your peril; do not wait until the announcement of EUDAMED readiness is published in the Official Journal of the EU before acting. Those watching all things EUDAMED have highlighted situations, including Olga van Grol-Lawlor in our recent Live! show, where competent authorities and economic operators are pushing hard for all data to be uploaded into EUDAMED now.
If you have the data ready, it may be prudent to ignore the delayed implementation dates and upload the data to EUDAMED now. Take this time to rigorously check its accuracy to avoid problems further down the road
5. Be transparent
Be clear with your notified body that you are maintaining your technical documentation. Confirm with your notified body whether they want you to submit updated documentation as it is available, or only once the review starts in earnest. Clarify with your notified body what they will be looking for in terms of PSUR timeframes, as your reporting frequency may fall out of sync with when the notified body wants an updated PSUR. In the absence of any agreement, once you get confirmation that the review is to begin, ensure that your reviewer knows that documentation has been updated and make it available for inclusion in their review. Do not be shy about it. You do not want to waste any of your permitted review questions on basic requests for the latest versions of documents.
Ensure that internal communications are also as transparent; keeping relevant internal stakeholders appraised of the situation, likely timelines and any expected changes to plans etc.
Want to Know more?
For next steps and more information, here are some fantastic options from our team and special guests:
- Read our two recent guides:
- Watch BSI's Richard Holborow and RQM+'s Amie Smirthwaite talk EU compliance in RQM+ Live! #69
- Watch Boston Scientific’s Olga van Grol-Lawlor and RQM+’s panel review the news and insights coming from autumn 2023’s long run of MedTech conferences in RQM+ Live! #73
- Follow #MedTechVoices on LinkedIn and get insights from our team as they analyze each of the opinions published by the Expert Panels as part of the Clinical Evaluation Consultation Process.
- Follow RQM+ on LinkedIn for all of our updates!