After postponing the start by one year due to the pandemic until 26 May 2021, the EU’s MDR (Medical Device Regulation) now applies. But what does the situation look like in the medtech industry?
Does MDR achieve the intentions?
Unfortunately, the new EU legal framework will not, as originally promised by the European Commission, simplify the market introduction of medical devices in the EU internal market, but rather complicate this process. For example, MDR contains over 100 more articles than the previous Directive (MDD). The MDR is a “basic act” which must be specified and governed by the adoption of a further 43 specific acts.
Few exceptions and new conditions
Since 26 May 2021, MDR must be complied with and exceptions exist only for medical devices in class IIa to III, for which an AIMDD / MDD certificate was issued before MDR came into force, which in turn is valid for a maximum of four years after MDR started to apply. The exception also applies to medical devices that, according to the MDR classification, require the involvement of a notified body. During this transitional period, however, neither the intended purpose nor the design features of the medical device concerned can change significantly, as otherwise the AIMDD / MDD certificate will lose its validity and cannot be renewed.
The transition period for the AIMDD / MDD certificate has been shortened from four to three years. Extensive new requirements for notified bodies, clinical evaluations of medical devices, recently documented plans and reporting obligations and the new Eudamed / UDI database system entail new framework conditions that require extensive preparatory work by the European Commission for the correct application of the new rules.
Manufacturers are ready, but facing challenges
In March and April 2021, the software company Climedo Health conducted a survey on the status of the EU’s MDR implementation one year after the postponement and a few weeks before the new validity date. 115 companies from all over Europe participated in the survey.
81 percent of those surveyed still find the MDR very challenging. The biggest challenges include increased need of resources and higher costs, lack of clarity and the need for clinical studies. 31 percent estimate that MDR entails additional costs of between 5 and 10 percent of annual sales. 13 percent even believe that the cost exceeds one tenth of sales.
For 43 percent, the MDR suspension has not facilitated their daily work. 72 percent now have a MDR-certified notified body and for almost 40 percent of these respondents it had not been difficult to find a notified body.
One of MDR’s biggest advantages would be traceability and transparency. However, 32 percent saw no benefits from the change. 75 percent want clear guidelines from the European Commission, 50 percent more technical support and 30 percent more training or information events.
– The survey results show that the EU-MDR continues to be very challenging, expensive and time consuming for companies, says Veronika Schweighart, founder and member of the management team at Climedo Health.
Above all, manufacturers of products with lower classification experience that the requirements are disproportionate in relation to the risk of their products. In addition, only a few companies seem to have clarified what applies.
The European Commission’s three major problem areas
Despite Climedo Health’s survey results, it seems that the medical technology companies are one step ahead of the “other” side, namely the European Commission, when it comes to the MDR, as they have not solved three major problem areas.
Problem area 1
Notified bodies: as of 17 May 2021, there were 20 notified bodies for the MDR. This number is far too small for all existing products to be transferred to the MDR on time. By comparison, under the old directive there were more than 50 notified bodies. But it is not just the number of notified bodies that is too small. Due to the increased requirements, the certification processes are also much more time consuming. This further reduces capacity.
The time pressure for companies and notified bodies is increasing. This conclusion was also drawn at the online symposium on the topic “MDR Audits – Best Practice & Learnings”, organized by Medical Mountains.
Notified bodies and successfully audited companies shared their insights and trends. The consultant and MDR expert, Dr. Bassil Akra, CEO of Quniques, made it clear that everything that was discussed could still only apply to the day:
– Tomorrow there may be new explanations for how to read and implement the regulation.
The purpose of the EU’s 175 pages on MDR was to answer questions and create harmonization. However, the now 55 guidance documents and various national laws showed that there is a great deal of uncertainty in Brussels and in the Member States about how to deal with the situation.
Problem area 2
Related to the previous paragraph, the status of each country’s legislation for the supplementation of MDR is very unclear. There are major differences between the countries. Much is in a preparatory stage but far from everything is solved.
Problem area 3
The next problem area is Eudamed. Eudamed is a database developed by the European Commission to implement certain requirements in the MDR and the Regulation (EU) 2017/746 on IVD. The database will be multifunctional and at the same time act as a registration system, a notification system and a dissemination system (with parts that are publicly available), which will improve the transparency and coordination of information on medical devices available on the European market.
In summary, the Eudamed database consists of six interconnected modules:
- Registration of economic operators
- UDI / product registration
- Notified bodies and certificates
- Clinical studies and performance studies
- Preparedness and monitoring after the market introduction
- Market surveillance
The various modules will be made available as soon as they are up and running. The first module, the registration of economic operators, became operational on 1 December 2020. The other modules have not yet been activated as of 17 May.
These three problem areas show that many medical technology manufacturers are largely ready for the implementation of MDR, but the system is not.
Julia Steckeler, CEO of Medical Mountains, summarizes the current mood in the medical technology industry:
– When MDR is now implemented, three groups can be identified. First, there are a few companies that have made great efforts and immediately began to formulate arguments and strategies and who are now in the fortunate position that they have already managed or planned for the most important certification audits according to the MDR. Then there is probably the largest group of companies that started just as early, invested a lot, are well prepared, but which without having done anything wrong are struggling with the problem areas in the not yet functioning MDR system. And then there is, fortunately only a very small, number of companies that are still postponing their work or even doubting the implementation of MDR.
The EU had good intentions with the new MDR. The result of various scandals was the ambition to create a new set of rules that would make it impossible to repeat them. By taking a holistic approach, they wanted to provide transparency and traceability, as well as make it easier for new products to enter the market.
The extension by one year gave time for more notified bodies to be registered and meant a breather in the work for many companies. But there is still a lot of ambiguity and many companies are lagging behind in their adaptation work. The costs for the products will also increase and – perhaps most importantly – so also the time before the innovations can give the sick a better life.
But whatever you think of it, the MDR is here to stay and you simply have to do the best you can. The alternative is to be outside the EU market, and other countries’ regulations are not always easy to comply with either.
This article is partly based on Die MDR ist da – und jetzt? from the German site DeviceMed.