EU MDR Designation of NB Updates
NB Listed in European Commission’s New Approach Notified and Designated Organisations (NANDO)
To date, two Notified Bodies have been designated under the EU Medical Device Regulation (MDR), which will be effective from May 2020
It was expected that another 20 Notified Bodies will be announced in the end of year 2019. However, the Notified bodies are restricted to accept any application under EU MDR until the Common Specifications are established.
TÜV SÜD Product Service GmbH Zertifizierstellen is the second NB designated recently in May, after BSI Assurance UK Ltd, which is the first NB designated in January.
As of 23 April 2019, 47 applications for NB have been sent to SANTE/F, of which 38 are for MDR and 9 are for IVDR. Below shows some statistics on post-assessment activities:
11 CAPA plans received by SANTE/F - 7 Joint Assessment Team (JAT) opinions issued - 1 CAPA plans undergoing official translation - 3 JAT opinions under preparation
2 Designating authorities' final reports received - 2 JAT opinion issued - 1 MDCG recommendation
Lloyd's Register withdraws from provision of NB services related to MDD and MDR
Lloyd's Register announced on 13 Jun 2019 the confirmation of their withdrawal from providing NB services relating to the Medical Devices Directive (93/42/EEC) (MDD) and the In-Vitro Diagnostic Devices Directive (98/79/EC) (IVDD).
LRQA also will not apply to be an Notified Body under the new medical device and in vitro diagnostic regulations (MDR and IVDR). LRQA issued letters to the manufacturer clients stating a 90 days’ notice rather than the required 30 days. LRQA will continue providing its third-party certification services relating to ISO 13485, Medical Device Single Audit Program (MDSAP) and medical devices-related training.
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