Regulatory News

EU Releases Working Plan to Implement MDR/IVDR

The European Commission (EC) issued a working plan on Wednesday for the implementation of the new EU medical device and in vitro diagnostics regulations (MDR and IVDR).

The EC’s working plan describes the legal basis, the expected adoption timelines and the current status of 12 implementing acts under MDR/IVDR and 12 other actions or initiatives.

The only implementing act in the roadmap that has been completed so far involves the defined scope of notified body (NB) designations, which was adopted last November.

“This action is an essential pre-condition for the launch of the designation procedure” for NBs, the EC said. It also speaks to a contentious issue in the road to MDR/IVDR, specfically regarding NBs’ availability and readiness to conduct required audits ahead of the application deadlines in 2020 and 2022.

Findings from a recent survey of all NBs for medical devices in the EU suggest these audits will not be completed in time, TÜV SÜD Product Service GmbH VP Bassil Akra noted at RAPS’ 2018 Convergence earlier this month. Only 7 of the 35 survey respondents had a joint assessment and not a single NB will be designated this year, Akra said.

An EC report on the current state of joint assessments of NBs for medical devices, which was separately issued on Wednesday, indicates only one joint assessment opinion has been issued.

Yet according to the working plan, a total of 33 applications for NB designation have been received and 22 joint assessments have been scheduled as of mid-September. These applications also cover the “full scope” of MDR and IVDR, the EC said.