In plenary in the European Parliament on the item “Review of the Medical Device Regulation” the future of the Medical Device Regulation was discussed.
Recall that with the adoption of the European Medical Device Regulation (MDR) 2017/745, the regulation has changed dramatically.
The main objective of the MDR is to “establish a robust, transparent, predictable and sustainable regulatory framework for medical devices, ensuring a high level of safety and health, while supporting innovation.”
Concerns about the future functioning of the European Medical Device Regulation (MDR) 2017/745 emerged in plenary at the European Parliament.
Currently, many key medical devices are no longer available.
In fact, Ms. Niebler Angelika during her speech essentially asked three questions of the European commission:
- “How does the European commission intend to ensure that medical devices remain available on the market?”
- “Should certificates already awarded remain valid until the verification of the certification application is completed?”
- “Is the committee considering an amendment to the MDR that would contemplate avoiding the need for recertification?”
Health Commissioner Kyriakides’ intervention requested that there was a need to add additional actions to the European regulation, 2017/745 MDR, this request also comes from member countries and stakeholders.
Therefore, there is a request to go and amend the MDR regulation and extend the transition period.
So as to avoid the risk of medical device shortages.
In December, key proposals will be presented to all health ministers at the health council with the aim of resolving the issues in the short and long term.
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