New European regulations for medical devices and IVDs set to enter into force in May 2017

European Commission officials provided an update about the new Medical Device Regulations (MDR) and In Vitro Diagnostic Regulations (IVDR) during the Eudamed Steering Committee meeting of 14 December 2016.

There have been discussions concerning the translation of the new Regulations, but the parties involved have been able to avoid the re-opening of formal negotiations.

The Commission has presented the following schedule:

End of January 2017: English versions of the MDR and IVDR expected to be ready;
Middle of February 2017: distribution of English versions and translations into all EU languages;
Beginning of March 2017: acceptance of the new version by the Council;
Beginning of April 2017: Regulations adopted by the European Parliament;
End of April 2017: formal publication;
End of May 2017: entry into force;.
End of May 2020: application of the MDR;
End of May 2022: application of the IVDR.

https://ec.europa.eu/growth/sectors/medical-devices/regulatory-framework/revision_en