On 12 December 2024, the European Commission launched a feedback period for a targeted evaluation of EU regulations on medical devices and in vitro diagnostics. The evaluation invites stakeholders to provide input on the effectiveness, efficiency, relevance, coherence, and added value of the regulations.
This assessment will help determine areas where the rules remain partially implemented, examine costs and administrative burdens, particularly falling on the SMEs, and explore potential simplifications that could be implemented. It will also consider the alignment of the regulations with other EU policies, including environmental and digital initiatives.
Objectives of the targeted evaluation
The targeted evaluation aims to determine whether the regulations:
- Effectively achieve their goals and address emerging needs.
- Provide EU-wide added value.
- Align with broader EU initiatives.
- Balance benefits with proportional administrative costs.
Stakeholders are encouraged to share their views here till 25 March 2025 to help shape a regulatory framework that supports innovation while ensuring safety and efficiency in the medical device and diagnostic sectors.
The entire MDR 2017/745 certification process is layered with cumbersome requirements as it is written today. When organizations get stuck and seek regulatory clarification it gets even more complicated as it apparent various professionals are not entirely clear either. If you ask different experts, you get different answers.
The organization I work for has finally been granted the approval under MDR 2017/745 for only ONE product which took years not months to finally get the job done. Also, a lot of expense. Our product is an occlusive wound care dressing which is the USA FDA is class 1 exempt, and in EU is class 11b. There is also much confusion with the rules between legacy product under MDD.
The first line of improvement would be to have the EU Medical Device Regulation (MDR) 2017/745 document itself written in a framework similar to ISO 13485:2016. Having to sift through this regulation with redundancies and going back and forth into different sections is ludicrous. Make the requirements straight forward and eliminate the redundancies. Additionally, if the regulation framework is simplified and straight forward it would improve the training and effectiveness. Organizations providing training on the MDR 2017/745 are not all doing the best job I can say this from experience. Auditing professionals all have different perspectives which compounds more confusion. The bottom line here is we have ONE product that has been on the US market since 2009 with zero adverse events. It’s a glorified wound dressing used primarily in the battle fields of the Military and is the preferred Brand (HALO). Sadly, from what our experience has been, it appears that the European community is overregulating to such a degree that some of the simple effective medical devices will not be made available to those end users that really need the best brand with proven over time very reliable performance.
I am very interested to follow this effort and incredibly anxious to see sensible improvements to the process.