Permitting Initial Virtual Audits Under The MDR: Commission Decision Hangs In The Balance
The European Commission is wavering as pressure builds for it to allow initial audits to be performed virtually under the Medical Device Regulation.
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Notified bodies may temporarily deviate, where fully justified, from the MDR and IVDR rules for notified body audits of manufacturers’ QMS to take place on site. Vital audits can now go ahead.
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.