- Regulatory House
MDCG 2022-11: Ensure timely compliance with MDR requirements!
Aktualizováno: 7. 12. 2022
Medical Device Coordination Group has published a MDCG Possition Paper- MDCG 2022-11 recommending manufacturers to submit their applications for certification of medical devices under the new legislation as soon as possible. Manufacturers are responsible to ensure that their devices comply with the MDR as from the end of the transition period. From that date, medical devices not certified under the MDR will have no access to the EU market.
In order to ensure that devices can continue to be placed on the market, it is essential that all manufacturers adjust their system, finalise transition to the MDR and apply to a notified body, submitting complete and compliant applications, as soon as possible and well in advance of the end of the transition period to ensure timely compliance with the MDR.
For more information see the possition paper in the following link: https://health.ec.europa.eu/system/files/2022-06/mdcg_2022-11_en_0.pdf