Updated Guidance Tackles Extent To Which Notified Bodies Can Provide Training Services
Notified bodies are not permitted to provide pre-certification advice to manufacturers. But an updated EU guidance document clarifies the extent to which notified bodies may offer training to their medtech clients.
You may also be interested in...
The European Commission has updated its figures on the status of readiness of notified bodies under the Medical Device and IVD Regulations. Three more designations are imminent, but just one under the IVDR.
It is vital that importers and distributors in the EU who are repackaging and relabeling medical devices know their responsibilities under the new MDR and are aware that they could be moving into manufacturer territory. New guidance spells out the new rules.
Guidance has been issued on exactly how the Medical Device Regulation requirements apply to ‘legacy’ and ‘old’ devices which remain on the market in compliance with the medical device directives.