European Medicines Agency Q&A guidance on the implementation of the MDR and IVDR update

The EMA has updated its Q&A guidance on the implementation of EU regulations for medical devices and in vitro diagnostic medical devices. When a declaration of conformity is not available for class I medical devices (excluding Is and Im), marketing authorization holders can submit a statement of compliance with the relevant general safety and performance requirements to meet the requirements of Article 117 of the EU Medical Device Regulation.

DOWNLOAD THE Q&A