Actually, the transition period for the re-certification of existing medical devices was to expire on May 26. Now the Council adopted the EU Commission’s proposal to extend the deadline.
The new medical regulation threatens bottlenecks for some medical devices. (Image source: Pixabay)
The Medical Device Regulation (MDR)
MDR is intended to make medical products even safer. The downside: bottlenecks are looming for certain products because the legal requirements cannot be implemented quickly enough. The extension of the deadline eases the situation somewhat for manufacturers of medical devices. They now have until the end of 2027 to certify their products. This deadline applies in the case of higher-risk products. Products with medium to low risk do not even have to be certified until the end of 2028.
Sales deadlines abolished
The amending regulation to the MDR also abolishes the sell-off period. This prevents safe medical devices that have already been manufactured from being disposed of.
The German Chamber of Industry and Commerce (DIHK) had repeatedly drawn attention to the far-reaching consequences of the MDR for medical care. It welcomes the changes that have now been adopted. However, further changes are still needed to help small and medium-sized enterprises cope with the high bureaucratic and cost burden.
Source: DIHK (german)
