The European Commission (EC) said on Friday it will issue a call for applications to set up the expert panels for the premarket product evaluation consultation procedures provided under the EU’s medical device regulation (MDR) and in vitro
diagnostic regulation (IVDR).
The EC is preparing to designate the new expert panels that will support the assessments for certain medical device classes and IVDs. The EU legislation obliges the EC to establish the expert panels in consultation with the Medical Device Coordination Group (MDCG). With a new one-pager, the EC explains the role that the selected clinical and other experts will play in MDR/IVDR.
MDR and IVDR explain the consultation processes on clinical and performance evaluations that require the designated experts to respond to notified bodies (NBs) and manufacturers of class III implantable devices and class IIb active devices for administering and/or removing medicinal products, as well as class D IVDs. The selected experts will be appointed in several different medical fields. They may either be appointed for a renewable 3-year term or “included on a central list of available experts from which they may be called to support panels,” the EC says.
Not only will the selected experts contribute to assessments of high-risk devices prior to their CE marking, but also to the future improvement of the MDR/IVDR framework. Experts will advise the EC, the MDCG, EU member states and manufacturers to help improve upon the framework. They will be involved in “contributing to the development of common specifications for clinical evaluation of device categories, guidance documents or standards,” the EC notes.
MDR’s framework is already nearing its 26 May 2020 date of application, followed by that of IVDR on 26 May 2022. The MDCG said in a document the EC posted
in March that clarification of a criterion under a provision relevant to setting up the expert panels—Article 54(2)b—is “extremely urgent notably due to its impact on the future workload of panels.” The document also reported the imminent launch of procedures to establish the expert panels.
The one-pager does not offer specifics for the when the EC will launch the call for experts this year. But the latest version of the EC’s rolling plan
on MDR/IVDR essential implementing acts and actions broadly set the target timeline for the expert panels’ establishment to Q3 2019.
Implementation delays were discussed
at the EU Ministers for Employment, Social Policy, Health and Consumer Affairs (EPSCO) earlier this month, following concerns raised
by German and Irish delegations. Yet on the May 2020 MDR deadline, the European Commissioner for Health and Food Safety said that industry and government “are on course to meet it.”