Dear All
Today is the deadline Jan 18th (midnight Brussels, Belgium time) for feedback to EU Medical Device Regulation (MDR) "Medical devices – transition period extension" regulatory proposal.
Full information here
https://ec.europa.eu/commission/presscorner/detail/en/ip_23_23
Feedback can be given here (Yellow "Give Feedback")
https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/13684-Extension-of-the-transition-period-for-medical-devices_en
There is already a shortage worldwide of some medical devices due to various reasons.
The MDR has caused manufacturers to stop manufacturing specific medical devices due to the cost of MDR compliance. MDR affects us all.
Therefore, full support from those outside of Europe is very appreciated. Thank you.
Below are some of the recommendations, comments and questions of MedTechXperts Ltd which have been posted on this EC feedback page. Please feel free to copy.
Best Regards,
Stephanie
Posted Recommendations to EC with Regards to Regulatory MDR Extension Proposal
- Time extension for all medical devices regardless of risk classification, including custom-made devices, should be the same year: either 2027 or 2028.
- Submission of an initial application for MDR certification to a notified body (NB) prior to end of 2025 should suffice to allow to qualify for the extension. Extra time would help all.
- Multiple conditions should be eliminated to qualify for the MDR extension
->Too short time frames are stipulated: Article 1 paragraph 3d (e) of the proposal assumes that the four months is sufficient time from application to written agreement with the NB. Legacy device manufacturers have reported to me spending months just trying to get a hold of their NB in order to submit the first MDR application.
Legality of the MDCGs? (Questions directed to EC and not Forum)
- Please address the legality of the MDCGs. Cover page of each MDCG states that they are non-legally binding.
- If they are not legal instruments, then should the relevant clauses of the MDCGs not be added to this regulatory proposal?
Additional Recommendations to increase efficiency and to lessen the load for all (i.e. NBs, manufacturers, research facilities)
-> Remove requirement of clinical development plan and clinical investigation for all devices, i.e. (i) generic devices with >10 years of proven market experience as CE certified device and (ii) medical devices providing an indirect medical benefit should be excluded.
------------------------------
Stephanie Grassmann
Founder & Managing Director of MedTechXperts Ltd
Biberstein
Switzerland
------------------------------