With Just 7 Notified Bodies Expected By Mid-2021, How Can Companies Prepare For The IVDR?
The EU’s IVD Regulation is going to apply just a year later than the EU’s MDR. Where are the gaps and how can industry manage the IVD notified body shortage?
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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.
The new EU MDR rules for economic operators are complex and burdensome for those not used to them. Chad Reynolds of RMQ+ outlines practical strategies for managing economic operators efficiently, and with a view to long-term compliance.