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UK NB Will Not Apply for EU MDR/IVDR

Posted 12 June 2019 | By Ana Mulero 

UK NB Will Not Apply for EU MDR/IVDR

London-based Lloyd's Register Quality Assurance (LRQA) announced Wednesday that it will withdraw from its notified body (NB) services under the EU’s current medical device and in vitro diagnostic directives and will not apply to be an NB under the new medical device and in vitro diagnostic regulations (MDR/IVDR).

“Following recent market developments and in the spirit of transparency, we have made the strategic business decision to exit from these services,” said LRQA customer experience director Claire Ruggiero.

LRQA directed clients to choose an alternative NB and establish a team to help with transition activities, with the goal of minimizing the risk of disruption. Citing the need to ease the transition, LRQA said it is providing 90 days’ notice rather than the required 30 days.

Ruggiero clarified that LRQA will continue providing its third-party certification services relating to ISO 13485 and the International Medical Device Regulators Forum’s Medical Device Single Audit Program (MDSAP). And the company will still provide “medical devices-related training to clients both in the UK and worldwide,” she said.

The moves by LRQA add to the difficulties in implementing MDR and IVDR and the concerns that span across the EU sector, which may be nearing an anticipated “cliff-edge” scenario. The German and Irish delegation also just recently elevated ongoing concerns with NB capacity under MDR. BSI UK and TÜV SÜD are still the only NBs to be designated under MDR so far.

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) identified next steps for manufacturers based on LRQA’s decisions, explaining the urgency of transferring to an alternative NB. LRQA said its services will cease regardless of whether the transfers are completed within the 90-day notice period.

Other solutions to combat a lack of NBs have also circulated.

In a recent position paper on recommendations for the issues around NB readiness and availability, the European Coordination Committee of the Radiological, Electromedical and Healthcare IT Industry (COCIR) pointed to leveraging MDSAP certificates to help offset a potential lack of NBs under MDR.

Categories: Regulatory News

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