The new European Medical Devices Regulation (MDR) will replace the existing Active Implantable Medical Device Directive (AIMDD) and the Medical Device Directive (MDD). As the new regulation is all set to take over, the manufacturers of medical devices will have to diligently identify areas which might affect their products’ market access in EU.
Given the fact that since the 1990s no major change has taken place in the European medical devices market, the new MDR is being seen as a major game changer in the industry. By adding elements like transparency and product traceability, the new regulation will simplify the rather complex medical device environment in the European Union.
Since 2010, Europe has witnessed a huge number of hip replacement recalls and breast implant crisis. The high rate of these incidents not only highlight the loopholes in the existing regulations but also underline the need for a new set of guidelines which can address the present-day medical complexities. And this is how the idea for the new MDR came into being. The goal of the new regulation is to provide:
- Impartial assessment of the safety and performance of the medical devices before being sold in the EU market
- Standardized rules for unproblematic trading between the members of the Union
- Specific needs of medium and small-sized manufacturers to be considered
- Transparency of information and patient-oriented innovation, along with comprehensive assessment of the risk-benefit aspect of the devices
- Greater responsibilities on “Notified Bodies” when it comes to the evaluation of the medium and high-risk medical devices
Infiniti Speaks – How to adapt to the new regulations?
The key to make a mark in the European market and leverage the regulations to one’s advantage is – early preparation and adoption. Depending on their product portfolio, manufacturers of medical devices must adhere to a well-structured approach in the upcoming three years.
It is advisable that manufacturers start by understanding the compliance data at the micro level for at least two to three of their products. The technical documentation of these devices needs to be submitted to the Notified Bodies to get a clear picture of the areas which need focused attention. By undertaking a gap analysis, manufacturers can figure out areas which need to be fixed to comply with the new regulations. Once the product gets evaluated, it gets easier to make changes to the wide range of medical device portfolio – way before the MDR comes into force. Also, there will be a pressing need to update and review all the technical documentation along with product labeling.
The whole process can get a little tedious and time-consuming, but starting early on is sure to help manufacturers to stay competitive and operational in the EU market.