EC Designates Third Notified Body Under MDR

Regulatory NewsRegulatory News | 14 August 2019 |  By 

The European Commission announced on Wednesday that Germany-based Dekra Certification GmbH is the third notified body (NB) to be designated under the Medical Devices Regulation (MDR).

Dekra joins Germany-based TÜV SÜD and BSI UK as the only NBs to be designated and listed in the European Commission’s New Approach Notified and Designated Organisations (NANDO) database. A fourth NB is expected to be announced soon, as the MDR/IVDR implementation rolling plan, updated on Monday, said that four NBs have been designated. That plan also said 52 applications have been received by the Commission services and 33 joint assessments have been carried out.

But several NBs have also declined to seek designation under MDR/IVDR. London-based Lloyd's Register Quality Assurance (LRQA) withdrew its NB services in June under the EU’s current medical device and in vitro diagnostic directives and said it will not apply to be an NB under the new MDR or IVDR. Swiss NB QS Zürich AG also decided to not pursue designation under MDR.

However, Vytenis Andriukaitis, the European Commissioner for Health and Food Safety, said in June that the Commission expects 20 NBs to be designated before the end of this year.

On the IVDR side, where no NBs have been announced as designated, concerns of a shortfall of NBs still linger.

European Commission


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