LRQA will not maintain Notified Body status under MDR/IVDR

Lloyd’s Register Quality Assurance has announced it will not maintain its EU Notified Body status for medical devices when the Medical Devices and In Vitro Devices Regulations come into force.

Lloyd’s Register Quality Assurance (LRQA) has given clients 90 days in which to find an alternative notified body (NB) to support their activities in device regulation. LRQA say:

“We will, however, continue to provide ISO 13485 and Medical Device Single Audit Program (MDSAP) third party certification and medical devices-related training to clients both in the UK and worldwide.”

The news adds to concerns that implementing the Medical Devices and In Vitro Devices Regulations (MDR and IVDR) will prove difficult, with only two NBs currently registered (BSI UK and TÜV SÜD) ahead of MDR coming into effect in 2020.

The very limited number of organisations available to deal with the workload in question has caused Member States to highlight the issue with the European Commission.

The announcement from LRQA is available here.

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Published on 13. June 2019 in News, News EU, News UK