Sep 13, 2021
The European Expert Panel established to provide scientific and technical expertise regarding in vitro diagnostic (IVD) devices under the In-vitro Diagnostic Medical Devices Regulation (IVDR) has begun accepting submissions from Notified Bodies for performance evaluation consultations.
According to a European Commission announcement, the IVD Expert Panel is now prepared to accept and assess submissions from Notified Bodies regarding Performance Evaluation Consultation Procedures specifically for high-risk IVD devices for which no common specifications are available. Expert Panel reviews will provide a crucial step toward CE Mark certification for these devices once the IVDR comes fully into effect following the Regulation’s May 2022 date of application in the European Union.
As a reminder, Expert Panels have been established in order to provide scientific evaluations and advice to EU regulators, Notified Bodies and manufacturers regarding safety and performance of medical devices and IVDs.
Per Article 48(6) of the IVDR, the IVD Expert Panel will provide feedback and assessments to Notified Bodies on issues related to performance evaluations of IVD devices; advise the European Medical Device Coordination Group (MDCG) on safety and performance issues of IVDs; as well as advise IVD manufacturers on their clinical development strategies and clinical investigation proposals.
The IVD Expert Panel will also play a role in the development of guidance documents, common specifications and international standards pertaining to in vitro diagnostic medical devices.
A look at the ISO 20916 standard for IVD device clinical performance studies
Despite widespread calls for postponement, the EC plan sticks to the May 2022 Date of Application and identifies what work needs to be completed in the meantime.