According to Medical Devices Regulation (MDR), May 26th 2024 is the end date of the transition period for legacy of devices that do not meet the MDR conditions. After this date, it will be possible to place on EU market only new medical devices for which the manufacturer have submitted an application for conformity assessment to meet the requirements of the new system to Notified Body. As soon as such conformity assessment is finalized, the manufacturer will have the right to market newly approved devices in EU.
In case of the certificates issued by Notified Bodies valid on the May 26th, 2021, will remain in force beyond the end date specified on the certificate depending on the class (under certain conditions):
- For class IIa, IIb, and class Is and Im devices – until December 31st , 2028
- For class III and implantable class IIb medical devices – until December 31st , 2027
Conditions which should be fulfilled to benefit from extended transition period:
- Devices continue to comply with previous applicable EU legislation (MDD/AIMDD)
- No significant changes in design or intended purpose
- Devices do not present an unacceptable risk to health or safety
The Medical Devices Regulation is complemented by the Regulation on in vitro diagnostic medical devices (IVDR). Medical devices belonging to Class I, which according to Directive 93/42/EEC (MDD) which should be reclassified to a higher class according to MDR, may be placed on the market until December 31st, 2028, under certain conditions. At SciencePharma, we are always up-to-date with the newest regulations. We sincerely encourage you to follow our website and to contact us whether you need expert services in the scope of medical devices.