MedTech Industry Calls for Urgent Reforms to EU MDR and IVDR
The MedTech sector has made stronger and stronger demands for a big change in the EU Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR). It has pointed out the problems that have popped up since the application of both regulations in 2021 and 2022 as the reasons for its demands.
The main goal behind the regulations was to get rid of unsafe devices and provide very good clinical evidence of the efficacy of the device. However, to the dismay of the industry, the current regulatory situation has resulted in long delays in approvals, added costs, and restricted patient access to state-of-the-art treatments.
Why Reform Is Needed
Organizations representing the med-tech industry, such as MedTech Europe and 34 national groups, claim that the MDR and IVDR, though very ambitious, have made the life of the manufacturers difficult. The complicated requirements for clinical evaluations, along with the notifiers having a small number, have resulted in bottlenecks mainly affecting small and medium-sized enterprises (SMEs).
A large number of companies complain about delays that last longer than the intended time frames, which have been a deterrent for consumers and thus hinder the flow of new products and innovation. What is more, differences in the interpretation of national regulations between EU member states have made matters of compliance even more complex.
This division of the continent into regulatory territories has caused, in addition to the slowdown of the market access, an increase in regulatory costs that have the effect of keeping small innovators out of the market.
Key Proposed Reforms
The MedTech industry wishes to see changes made to the structure and to the processes in order to make the MDR and IVDR less cumbersome without putting the safety of the patients at risk. Among the most important recommendations are:
⦿ Simplified Clinical Evaluation Requirements: The removal of Clinical Data requirements which are redundant or very complex could benefit the approval process greatly and still be safe.
⦿ Enhanced Notified Body Capacity: Expanding the number and capability of notified bodies is critical to handle the growing volume of device assessments efficiently.
⦿ Harmonization with International Standards: By bringing EU regulations closer to global standards such as ISO and IMDRF guidelines, the problem of duplication would be minimized, and the process of global market entry would be facilitated.
⦿ Clearer Guidance for SMEs: If the targeted assistance and guidance are given, then the smaller companies would be able to navigate through compliance more effectively, which would result in more innovation and competition.
Benefits for Medical Device Manufacturers
If implemented, these reforms could create a more predictable and efficient regulatory environment. Manufacturers would benefit from faster approval timelines, lower compliance costs, and smoother access across EU markets. This, in turn, would encourage innovation, investment, and the development of new medical technologies.
Harmonization with international standards is particularly important for companies targeting both EU and global markets. Simplified regulatory activities could dedicate more attention to product development, clinical trials, and patient-centered innovation, thereby improving healthcare delivery.
Next Steps and Stakeholder Engagement
The European Commission has started to review the recommendations made by the industry and will soon offer a public consultation process. It is very important to engage with stakeholders to make sure that the proposed reforms not only solve the real-world difficulties but also maintain safety and efficacy.
The industry has emphasized that any changes should balance regulatory rigor with practical feasibility, ensuring that patients continue to have timely access to innovative medical devices while companies can comply efficiently.
To read more about the news, you can go through the official link below:
MedTech Industry Calls for Major Reforms to MDR and IVDR – RAPS
