Article 59 (EU MDR) and CE Marking FAQ
What is Article 59?
What’s its purpose?
When is it appropriate to use it?
We answer these questions and more…
What is Article 59?
What’s its purpose?
When is it appropriate to use it?
We answer these questions and more…
Article 59 sets out how authorisation of CE Marking requirements derogation for medical devices (not IVDs) can be done. Clin-r+ provides guidance on Article 59 and CE mark derogation.
EU MDR Article 59 and CE Marking for Medical Devices Read More »