The European Union (EU) Medical Device Regulation (MDR) initially published in 2017, set the guidelines for EU medical device manufacturers to follow. In this article we take a look into the EU MDR, breaking down its most important parts and decoding what it means for the European region.
The EU MDR is a unified and updated form of EU’s previous two regulations: the Medical Devices Directive (MDD) and the Active Implantable Medical Devices Directive (AIMDD). Published in May 2017, the EU MDR allowed a 3-year transition period for medical device manufacturers to comply. This runway ends in May 2020, where after the EU MDR comes into full effect. After this point, every part of the medical device supply chain from manufacturers to importers and distributors in the EU, will be required to comply.
For the case of high-risk devices, the 2020 EU MDR enforces stricter pre-market (ex-ante) controls than MDD. Apart from the new scrutiny mechanism, these controls will be conducted with the involvement of EU level expert pools; this will both enforce compliance and also bridge any gaps between authorities and medical device companies.
Some aesthetic devices pose the same risk for patients as some implantable medical devices; with numerous examples of problematic results in subjects. Therefore the EU MDR will include certain devices that serve an aesthetic function (eg. implants).
The new regulation emphasizes medical devices traceability and identification. Firstly, it enforces the usage of a unique device identification number, corresponding to a central EU database. Secondly, it introduces the concept of the implant card: a card containing information about a patients’ implanted medical devices.
The EU MDR requires the demonstration of medical devices’ effectiveness through clinical evidence, regardless of whether it has been in the market or not. In order to allow for such a massive amount of clinical data to be generated, the EU MDR also introduces a new procedure for authorizing multi-center clinical investigations throughout the EU.
From May 2020, the new regulation taking effect will be backed with a variety of actions aiming to ensure strict rules enforcement. Firstly, the notified bodies tasked with enforcing the EU MDR throughout the European countries will have reinforced criteria for designation and processes by the EU. Secondly, the EU will strengthen post-market requirements for medical device manufacturers. Lastly, there will be an effort for utilizing improved mechanisms of coordination between EU countries regarding vigilance and market surveillance.
The new EU MDR is intended to improve medical devices’ quality, safety, performance, and reliability. For this reason, it emphasizes on clinical evidence, as well as transparency and traceability of medical devices throughout their lifecycle and supply chain. Moreover, it is adapted to new innovation, bridging any gaps between technology and regulations.
A factor that will have a big impact on the industry, is that clinical data is required for every medical device in circulation. This means that companies will have to bear the cost of demonstrating clinical data for every device marketed, which in some cases may not be economically feasible, for example in the case of some devices that have low sales. So a big task for medical device companies will be to conduct a cost-benefit analysis in order to determine which products are worth keeping in their portfolio and hence will require the demonstration of clinical evidence to keep in the EU market.
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