With just about 11 months left before the date of the application of the EU’s medical device regulation (MDR), time has not provided the answers to everything. An EU MDR expert spoke to Focus
recently via email about four troublesome areas.
Gert Bos, executive director and partner at Qserve consultancy, drew attention to issues that have festered in the MDR transition period—a lack of portfolio coordination, an EU-wide supply bottleneck, notified body (NB) capacity and delays in business preparations—and advised on navigating the "grey zones." Bos highlighted glimmers of hope in some areas but also explained why many share concerns about a pending crisis, despite efforts made by industry, regulators and member states.
Q: As someone who has traveled across the world to provide guidance and support on challenges facing the MDR transition, what is your biggest concern overall as of today?
Most concerning is the absence of any portfolio coordination. Occasionally, I am shocked to see that companies decide to remove even their core products from the portfolio. Sometimes it is the European or global “golden standard” product that many competitors also refer to in their dossiers, either in equivalence or in state of the art. More generally speaking, nobody knows if and what products will remain available to health care providers as there is no EU-wide portfolio coordination taking place.
In the next few years, hospitals may face an inadequate stock of products and unavailability of others. Replacing one product for the next might come with future product adjustments to be used in a system, with validations, many contractual changes and logistical challenges. But I am also hopeful that the commitment and dedication of health care workers will get us through safely.
Q: Industry groups have warned about an EU-wide device supply bottleneck. Where did this concern originate and to what extent could it influence the MDR transition period?
A serious number of products already face problems in obtaining interim certificates against the Medical Device Directive (MDD) today. Companies are now working on getting to MDR level, meaning that their documents and all the technical files are being upgraded. NBs might select files that are still early in the upgrade process as samples during the assessment.
Another concern is that many documents are being prepared and interpretations are discussed in small circles in Brussels. Much of that is not reaching manufacturers' teams that are building documentation. New guidance might become available while time passes with dossiers in the NB cue. But this will result in a list of deficiencies and longer delays to get the MDR certificates.
Q: Two member states described NB capacity as “the most imminent and high-profile challenge.” How can industry act now to help relieve a potential NB shortage later on?
Timely compliance is workable if a manufacturer secured a certificate to get through the grace period until 2024. But most NBs have already closed applications for early certificate renewal and demand MDR compliance even though they are not yet designated. A clear grey zone opportunity is to continue fast MDD certificate renewals to allow industry to maximize the time in the grace period and obtain MDR certificates after lengthy NB assessment cues.
As for the delays in NB designation, that is partially built into the process. That is the reason for the grace period to have been included. The intent is to clean house in the NB field and that is happening. Only a limited number of NBs have applied and resourcing will be way too thin. As a consequence, authorities have now started to discuss if government bodies might play a role in the assessments. This would potentially create a stepping stone to a more centralized system in a future legislative reform.
Q: At the FDA/Xavier MedCon conference, some participants reported being in the early stage of preparations. What should late starters know to expedite MDR preparations?
Hire, hire and contract out. Hire double the Quality Assurance staff that you currently have. Hire triple the Regulatory Affairs staff that you currently have. And outsource the rest. Excuses on workload and unavailability of systems and resources will likely not be accepted. So, do not count on it. Do what you can.
Industry and authority delays are very much depending on each other. As delays occur in NB designation, building Eudamed, supporting UDI, providing guidance on GSPR expectations and detailing what diffident clinics data entails, many in industry do not feel pressure and urgency to comply as it is not their fault that the system is not ready.
Q: What do you make of this discussion around “navigating the grey” at RAPS’ EU conference last month?
There are a lot of potential grey areas and these are primarily situations where black and white are not helpful. Perhaps metaphorically, we could call it a grey zone as it is a different behavior to move on and take decisions case-by-case and topic-by-topic that for now, is enough to look for a practical approach.
We can demand much in law, but manufacturers’ best efforts to do what is right and improve from the past should be enough if the interpretation of the law is unclear about what is expected. Further improvements can be made later when more details on expectations become known and documented. The more grey zones that we can utilize, the safer we all will be. After all, the products that are used today in hospitals are safe and new documentation requirements not yet fully assessed will not immediately turn them unsafe.