• Regulatory NewsRegulatory News

    EC Unveils First Notified Body Designation Under IVDR

    The European Commission (EC) on Thursday revealed that Germany-based Dekra Certification GmbH is the first notified body (NB) to be designated under the EU’s In Vitro Diagnostic Regulation (IVDR), which takes effect in May 2022. The designation, which follows Dekra’s previous designation as the third NB under the Medical Devices Regulation (MDR) in August, comes as experts have warned that there may be a shortfall of IVDR-designated NBs . Similar concerns have been ...
  • Regulatory NewsRegulatory News

    EC Designates Third Notified Body Under MDR

    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...