MDR date of application postponed; MDD remains in force

04/24/2020 | Dr. Guido Middeler

Dr. Guido Middeler

The European Parliament and the European Council have finally agreed to the EU Commission’s proposal to delay the date of application of the MDR by one year until 26 May 2021. The announcement has already been published in the Official Journal. Manufacturers of medical devices now have more planning security again. Products that have been on the market according to the “old” standards of the Medical Device Directive (MDD) and are not yet MDR-compliant are given another chance. In addition, the Medical Device Coordination Group (MDCG) and the EU Commission have a little more time to prepare comprehensive and target-oriented guidelines for the implementation of the MDR.

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!



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