The European Commission formally announced on 25th March, that they request a 1 year delay for the MDR Date of Application (26 May 2021 instead of 2020); this measure is expected to adopted by the European institutions (European Parliament and Council of Ministers) by mid-April.
This delay is prompted by the Covid19 world crisis, to ensure Member States, Notified bodies and Manufacturers, that they will not get further disruption for product market access.
At that stage, there is no impact communicated on the EUDAMED development plans. atrify keep monitoring the situation very closely, and are committed to being fully ready to enable manual and M2M customers to register UDIs into EUDAMED as soon as the UDI registration module is made available in production by the European Commission. In the meantime, atrify keep testing together with leading manufacturers the UDI module, and sharing feedback with their community and the European Commission to ensure they are well prepared for a smooth go-live of EUDAMED.
