Dr. Guido Middeler
Partner
Manufacturers of medical devices can continue to rely on the regulatory framework of the MDD. Products now re-certified – or even newly certified – under the MDD will retain their marketability and can be placed on the market for the first time until May 2024 and sold until May 2025. The same applies to class I medical devices that will in the future require a notified body in accordance with MDR, but for which a valid declaration of conformity is issued before 26 May 2021. With minimum effort, this option allows four more years for established products that have been proven safe.
By 26 May 2021, the manufacturers concerned can also implement an MDR-compliant quality management system and hope for more clarity through further European guidelines regarding the correct implementation of the requirements. To prevent the internal quality management from being overloaded with parallel systems according to the MDR and other standards such as GMP, the entire responsibility for medical devices can be outsourced to a service provider such as Diapharm. Changing the notified body is permitted. Get in touch with us!