Since May 25, 2017, the EU’s Medical Device Regulation (MDR) has repealed the previous Medical Devices Directive [93/42/EEC] (MDD) and Active Implantable Medical Devices Directive [90/385/EEC] (AIMD). At the end of the three-year transition period, the new Regulation will fully come into force on May 26, 2020. At that point, all medical devices must be recertified to meet the requirements of the MDR.
The transition period for the new Medical Device Regulation is soon coming to an end. Companies continue to be confused about the do’s and don’ts and deadlines. That’s because the EU has still not clearly resolved some outstanding issues.
The new Regulation was the direct result of a scandal involving breast implants manufactured by Poly Implant Prothèse (PIP), which were made from industrial-grade silicone. The amendment to the certification process is designed to further improve patient safety and aims to minimize differences within and between EU member countries pertaining to the implementation of the Regulation. This essentially well-intended approach is welcomed by medical device companies. However, the implementation proves difficult, as Hans-Peter Bursig of the Electrical and Electronic Manufacturers' Association (ZVEI) points out in a COMPAMED.de interview (read the interview here). He considers the lack of “new” Notified Bodies a big problem: "Manufacturers are now waiting for the newly designated Notified Bodies to start the CE marking process for their devices. […] Even if they would be in place by fall 2019, it would still be difficult to finalize all processes by May 2020." That’s because all previously designated Notified Bodies must also get re-accredited to be able to certify according to the new MDR requirements. Yet this is a long and arduous process that takes time. With just one year of the original transition period remaining, there is only one Notified Body designated under the new MDR so far - and it's located in the UK of all places. It will get de-designated post-Brexit- whenever that may be. This means the CE markings obtained from this body will no longer be valid at that point. As it turns out, Brexit also plays an obnoxious role in this process.
Is the MDR crippling innovation?
Manufacturers are not just worried about renewing certifications of existing (legacy) products. Some companies also fear their products might be reclassified to Class IIb (active devices) or Class III (implantable medical device). Since this entails a scrutiny process for high-risk products, makers consider taking certain products off the market. This might affect niche products, which are not very profitable but are still vital devices for some patients.
If you are well prepared ahead of time and have supplied all the supporting documents, you can relax and wait for the Notified Bodies to soon begin the certification process.
In January, the Association of German Chambers of Commerce and Industry (Deutscher Industrie- und Handelskammertag, DIHK) and SPECTARIS – German Medical Technology Trade Association (Fachverband Medizintechnik) published some interesting data (DIHK/SPECTARIS-Umfrage, 2019). In a joint research survey, 320 companies completed an online questionnaire that was subsequently published by the German Chambers of Commerce and Industry. According to the publishers, respondents voiced the following concerns:
It will be more difficult to bring innovative products to the market in the future.
They will be forced to cut their product portfolio.
There is an insufficient number of Notified Bodies to get all devices certified in time.
What is certain is that manufacturers can expect higher costs to certify their products, which is why they have to choose carefully and decide which devices are worth the effort. Achim Dercks of SPECTARIS cautions: "There is a danger that many smaller companies will experience market access problems for their products. This threatens their very existence and subsequently slows down the pace of innovative medical devices to help patients.” (Press release: February 1, 2019)
At this juncture, it’s still unclear whether and how the new Regulation will economically impact manufacturers. Large companies are in a position to create new jobs to handle the extra work that’s required. Small companies tend to rely on external consultants, which means additional costs, or they assign the new task to a team member, which in turns means they will lack an employee in another area. Whatever the solution may be for the respective enterprise, all companies should already have many approvals and certifications ready at this point to be fully prepared once the Notified Bodies are available. Even though the new Regulation ultimately requires more work for medical device companies, it can actually benefit patients by increasing their safety.
Please refer to the box below for more helpful links to the MDR and its implementation.
Link Collection Medical Device Regulation EU
Pages of the European Union:
NANDO (New Approach Notified and Designated Organisations) Information System; Lists the Notified Bodies for various products, including the new MDR