Essential IVD Document Delays Add To Concerns Over 2022 Deadline
The IVD Regulation is due to fully apply on 26 May 2022, but the infrastructure for manufacturers to demonstrate compliance and for notified bodies to perform their audits according to the new rules keeps being delayed.
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The IVD Regulation is due to fully apply in May 2022. The necessary infrastructure looks unlikely to be ready in time. But industry faces a dilemma: will lobbying and pining hopes on a delay be the best use of its resources?
The UK responsible person is the UK equivalent of the Authorized Representative in the EU. MedTech Europe’s Jesús Rueda gives an update on the early experiences of medtech manufacturers seeking to comply with the UK’s new standalone regulations.
The European Commission has reluctantly allowed virtual audits in the context of new MDR and IVDR. The EU notified body association is helping the collective effort to meet its strict requirements.