The new Medical Device Regulation (MDR) from the EU has left no stone unturned in the medtech sector. Companies are facing huge challenges.
Only those who adapt their development and production efforts to the MDR as soon as possible will remain competitive.
In order to successfully introduce new products to the market, the first development steps must be documented seamlessly from the start and in accordance with the MDR provisions. If something was overlooked at the beginning, it can no longer be easily rectified at a later date. This means going back to the start in certain circumstances, losing all of the capital invested thus far in the product development.
With the MDR, the EU is tightening its requirements for medical technology products, from bandages to pacemakers. The definition of a medical product has been expanded and more products are classified as risks. The technical documentation and clinical test requirements have also been intensified and expensive clinical trials are required for more products. Specially trained personnel must also be employed in the future to guarantee that the company complies with the MDR.
After a medical product has been placed on the market, compulsory reviews (so-called post-market surveillance) will see repeat and re-certification audits carried out every three to five years. Thus, manufacturers will still be held liable even after approval has been granted. Even employees at the so-called notified bodies must be prepared and trained in the MDR provisions. This will mean that more personnel will be required in the future as one person alone will no longer be able to cover and check the entire spectrum of medical products. Against this background and the associated, necessary investments, the ‘extinction’ of notified bodies has already begun. Currently (early 2017), there are still around 60 notified bodies across Europe, and medical technology companies will be queueing up for audits. This will lead to a delay in the market entry of products. The last remaining notified body in Austria, the Graz University of Technology, ceased their activities in October 2016.
A dramatic increase in requirements
The checks and documentation required in the MDR mean that the costs for the development and market entry of medical technology products will increase for companies. Even the unannounced inspections that are planned will create more costs for companies.
In many cases, the approval procedure will take longer. Market launches and innovations may be delayed and lead to a competitive disadvantage for European medical technology manufacturers. This is frightening investors away. If, in the future, manufacturers must disclose their supply chains and product details, then this disclosure of company knowledge, internal data and business relations may have a negative impact on the companies concerned. And: All MDR provisions shall apply retrospectively in the sense that even medical technology products that have been on the market for decades must go through the entire MDR procedure and must be MDR certified. A foreseeable consequence of this is that companies will calculate the yields from existing products exactly, and refrain from applying for the expensive MDR certification for lower yield products and simply remove these products from the European market.
If companies want to continue to be successful in the medical technology sector, then they must completely rethink and adapt their research, development and production processes. Tyrolean companies can count on the support of Cluster Life Sciences from Standortagentur Tirol.
Dates and deadlines
The new EU regulations for medical products & IVDs were published on 5th May 2017 in the Official Journal of the European Union, and came into force a few days later on 26th May 2017. From this point forward, the transitional provisions (Article 120 (MDR) and Article 110 (VDR)) applied. The regulation for medical devices is mandatory from 26th May 2020 after a three-year transition period. The transition period for the regulation of IVDs is five years, therefore this is mandatory from 26th May 2022. In order to carry out certifications under the new legislation, notified bodies can re-name themselves six months after the MDR comes into force at the earliest (so early December 2017).
You can read the Medical Devices Regulation and find more information here.