Competent Authorities for Medical Devices Publish Medical Devices Regulation/In-vitro Diagnostics Regulation (MDR/IVDR) Road Map

• 10/11/2017
• Articles

On 7 November 2017, the Competent Authorities for Medical Devices (“CAMD”) published their final and eagerly anticipated road map for implementing: (i) Regulation (EU) 2017/745 of 5 April 2017 on medical devices (the “MDR”); and (ii) Regulation (EU) 2017/746 on in vitro diagnostic medical devices (the “IVDR”) (the “Road Map”).

The Road Map lists the priority actions for the effective implementation of the MDR, which will apply from 26 May 2020, and the IVDR, which will apply from 26 May 2022. CAMD prepared the Road Map in close collaboration with the European Commission.

The priority actions are classified according to seven technical areas/work streams. In addition, some more general and overarching priorities are included. For each priority action, the Road Map identifies a recommended responsible party and a generic priority level (high, medium or low). The individual working groups tasked with each activity will define more specific priorities.

CAMD announced that “[t]he detail in this document is likely to evolve as the work programmes develop”. Politico reports that an edited version of the Road Map may follow as early as next Monday.

The Road Map can be consulted here.