The European Parliament has adopted a new Medical Device Regulation – MDR for short – which must be compulsorily applied from May 2021. Only some medical devices still have a transitional period. This means that the various EU countries no longer have any leeway for their own interpretations, because the regulation affects the entire product life cycle from the clinical test phase to the market launch – of both new and existing products.
The requirements for the manufacture and test phase of medical devices will be tightened and harmonised throughout Europe. This affects numerous aspects such as more stringent clinical evidence for class III medical devices, systematic clinical evaluation of classes IIa and IIb and the abolition of grandfathering. The last point in particular, “grandfathering”, is a good example of how extensive the new requirements are. This is because manufacturers must now have all currently approved products re-tested and re-certified according to the new requirements. The smooth functioning of the internal market is the main focus here, among other things through uniformly high quality and safety standards. In addition, technological and scientific progress should also be incorporated. While the use of new technologies should lead to greater efficiency for MedTech companies, compliance with the regulations is primarily associated with more work.
According to our MDR specialists, the additional administrative workload should not be underestimated. It is not only the new requirements that are challenging, but also the MDR system itself. It has its pitfalls and is not yet optimally adapted to the “new load“. Many companies have already successfully passed an MDR audit – but by no means all of them. Those who are still in the transition phase or are planning it are well advised to rely on highly qualified, external MedTech professionals. Freelance MedTech specialists know the live scenario, have many hours of project experience and find an efficient solution approach for each MDR hurdle.
Opportunity or hindrance? The new MDR can be both – depending on your perspective. In many ways, the new regulations require processes that manufacturers should follow anyway, but implementing them is a challenge, especially without the right technology. This primarily affects the product teams involved in the approval process. MDR specialists can provide support – with efficient new processes and the right technology. The result: innovative and high-quality medical products that can be quickly launched into the European market. The new MDR can therefore also be an excellent opportunity to stand out from the competition – both now and in the future.