The Medical Device Regulation (EU) 2017/745 became the applicable EU law on May 26, 2021. After a four-year transition period, the first MDR approved devices are now hitting the market. What lessons have we learned? Well, let us have a look. There are currently only 25 of the 53 notified bodies under the prior Medical Device Directive (MDD) that have achieved their designation. And many of them are still operating with limited scopes and limited resources. This has created long lead times to begin an MDR project. As of today, DNV is accepting MDR applications but the timelines are now 8–10 weeks to start a project for most medical device categories. But many notified bodies are not even accepting MDR applications for certain medical device categories or generic device groups, causing manufacturers to embrace new project timelines that are approaching 12–18 months.
So, what can be done to lessen the impact on timelines, created by the lack of technical resources, as well as a steep learning curve for both manufacturers and notified bodies? We recommend speaking with your consultant and/ or notified body today to verify if your regulatory strategy is still sound. I recommend focusing on the five core challenges that have been affecting manufacturers: Clinical, Risk Management, Usability, Labeling and Post-market Surveillance.
These challenges are not in order of importance or difficulty. Let us use an example of a recent client’s challenges submitting under the MDR. Updating your technical data should begin (but not end) by completing an Annex I – General Safety and Performance Requirements (GSPR) checklist. Completing the GSPR checklist will allow the manufacturer to see what data / documents are available to satisfy the technical documentation requirements under MDR Annex II. For example, is your clinical data reliant upon other legacy devices on the market? Have you updated your literature studies to the current year of making your MDR application? Do you need to rewrite your clinical evaluation report (CER)? Plan ahead by having your CER reviewed well before submitting, because it can be a time intensive and costly project.
Get more insights from Robert Dostert, Dr. Bassil Akra and Michelle Lott by watching the on-demand complimentary webinar, “EU MDR Lessons Learned“Another key concern is post-market surveillance (PMS). Under MDR Annex III, a manufacturer must have a plan to collect and utilize available information in a proactive and systematic way. Michelle Lott of leanRAQA elaborates, “Even new products must have a detailed post-market surveillance plan (PMSP), including post-market clinical follow-up (PMCF), and a suite of procedures describing in detail, how you will conduct PMS in all the iterations applicable for your product. You will likely have a post-market clinical follow-up plan (PMCFP) and a periodic safety update report (PSUR), all of which must feed into your CER. Manufacturers should prepare to do as much work in post-market to keep their devices on the market, as they did pre-market in preparing the submission to keep them on the market from certification cycle to certification cycle.” When submitting your technical data, your PMS technical documentation should be presented in a clear and searchable way according to Article 83-86. Your notified body will be expecting to see your PMS plan as well as your PMS activities become an annual and active approach. A few examples of being proactive could include utilizing national device tracking registries and user /medical staff feedback. The more innovative your technologies are, the more robust your post-market clinical follow-up is expected to be.
Another challenge is addressing your labeling, this can quite possibly become a separate project, as there are more than 60 requirements that must be met. You will notice under “Labeling and instructions for use” (see GSPR 23), there is a good checklist to follow. The most notable requirements are listing your UDI number and economic operators. As always, you are required to use internationally recognized symbols. I recommend reviewing ISO 15223-1:2021 and ISO 20417:2020 for additional guidance.
Risk Management has always been required, but the level of detail and approach has been elevated. No longer is a simple FMEA going to pass an MDR notified body review. Ms. Lott encourages, “Manufacturers need to apply risk management tools throughout the product life cycle. For instance, tools like a preliminary hazard analysis and Weibull tools work complementary with an FMEA to more thoroughly capture risk activities throughout a device’s lifecycle.”. Here is an excerpt from GSPR 3: e) evaluate the impact of information from the production phase and, in particular, from the post-market surveillance system, on hazards and the frequency of occurrence thereof, on estimates of their associated risks, as well as on the overall risk, benefit-risk ratio and risk acceptability. This is a much larger challenge for many manufacturers. Ms. Lott adds, “Usability reflects another subset of risk management that many manufacturers have overlooked or under-addressed. The usability process should actually start pre-design inputs in the form of a use specification document that articulates user needs for conversion into design inputs.”
With the increased scrutiny under the EU Medical Device Regulation (MDR), notified bodies are required to reassess all technical documentation, including clinical evaluation report, by applying new acceptance criteria. Since notified bodies are not permitted to simply accept previously accepted safety and performance history under the prior medical device directives, even legacy devices may receive a negative certification decision or require additional pre- and post-market clinical evidence under the MDR.
According to Dr. Bassil Akra, AKRA Team, “The EU Medical Device Coordination Group has tried to clarify these requirements by publishing guidance documents on sufficiency of clinical data for legacy devices, Class III and implantable devices, by explaining the approach of clinical equivalence and by sharing templates on the best approach to address the legal text regarding post-market surveillance obligations. Despite all available guidance documents, the requirements of the EU MDR with regards to clinical evidence and, especially, post-market clinical follow-up for the different types and classes of devices remain unclear and unharmonized. The situation is getting unmanageable for all parties: notified bodies are trying to do their best to ensure independent assessment activities by interpreting the requirements carefully; manufacturers are interpreting the requirements based on the current legal text and guidance documents, since they are not allowed to have pre-submission meeting with their notified bodies similarly to the old directives time; and designation authorities are trying to show more surveillance power by enforcing their view on their notified bodies without considering the impact of all this high scrutiny on essential products for the EU healthcare system.”
Although the MDR has created much uncertainty amongst all stakeholders, we are now seeing many lessons learned coming to light. As more guidance is released, we can expect to see more agreement between competent authorities and notified bodies. Until this happens, there are still things that you can do today to help eliminate the uncertainty: reach out to your consultant for help, then choose your notified body and authorized representative earlier than planned. Read the available guidance documents, such as the recently released MDCG 2021-25, regarding legacy devices and utilizing harmonized standards. Following these steps will better prepare you to make necessary investments to ensure market continuity and shorten the project timelines.
There is more and more guidance and support being released daily from The Medical Device Coordination Group (Guidance – MDCG endorsed documents and other guidance | Public Health (europa.eu) as well as Team-NB (www.team-nb.org). These are invaluable resources for the industry to understand the application of MDR in their technical documentation and quality management systems.
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