The European Commission Approves to Postpone the MDR Application Date by One Year

European Commission has approved to postpone by one year the date of application of the Medical Devices Regulation (EU) 2017/745 to allow the Member States, health institutions, and economic operators to prioritize the fight against the coronavirus pandemic.

The European Parliament postponed the enforcement date of the regulation (EU) 2017/745 (now (EU) 2020/561) on Medical Devices from 26 May 2020 to 26 May 2021.

The European Medical Device Regulation (MDR) is a new regulation that regulates the production and distribution of medical devices in Europe, and compliance with the regulation is mandatory for medical device companies that want to sell their products in the European marketplace.

The manufacturers of medical devices take prime responsibility for getting their products CE-marked for the European market. Now, they need to manage the change to get their products CE-marked under the new Regulation and will have to comply with the MDR by May 2021.

More information

https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32020R0561&from=ENhttps://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32017R0745&from=ENhttps://ec.europa.eu/growth/sectors/medical-devices_en

May 13, 2020, by Ahmad AbdElnaby