IMPLEMENTATION ROLLING PLAN Regulation (EU) 2017/745 and Regulation (EU) 2017/746. Update dec 2020

 

This rolling plan contains a list of identified essential implementing acts and other relevant initiatives that the Commission has adopted or intends to adopt in the future. This plan is divided into two sections: implementing acts, and other actions/initiatives. This document is subject to quarterly review in order to provide national authorities and stakeholders with the most updated information.

This document shall be read in conjunction with the “MDR/IVDR roadmap” adopted by the Competent Authorities for Medical Devices (CAMD) in cooperation with the Commission (available at https://www.camd-europe.eu/regulatory/medicaldevices-regulation-vitro-diagnostics-regulation-mdr-ivdr-roadmap). A list of ongoing MDCG guidance documents is available at https://ec.europa.eu/docsroom/documents/37921.

NOTE: Regulation (EU) 2020/561 of the European Parliament and of the Council deferred by one year the date of application of Regulation (EU) 2017/745, until 26 May 2021.

 

implementation rolling plan