FDAnews Device Daily Bulletin
Medical Devices / Regulatory Affairs

EC Creates Expert Panels to Review MDR Implementation

July 3, 2019
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The European Commission is creating expert panels to review the implementation process for the EU’s new medical device and in vitro diagnostics regulations after numerous industry groups have sounded alarms over the delay in implementing the new regulations.

With less than one year to go for devices to meet the May 26, 2020 implementation date — IVDs have until May 26, 2022 — the expert panels will assess high-risk devices and “contribute to the prospective improvement of the overall framework by advising the Commission, the Medical Device Coordination Group, Member States, notified bodies and manufacturers.”

The panels will also take on other tasks such as contributing to the development of common specifications for clinical evaluation of device categories, guidance documents and standards.  Experts on the panels will be appointed for three-year renewable terms.

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