Tag Archives: Annex XI

Dr. Christopher Joseph Devine, President, Devine Guidance International
Devine Guidance

MDD – Annex XI

By Dr. Christopher Joseph Devine
No Comments
Dr. Christopher Joseph Devine, President, Devine Guidance International

The takeaway from this edition of DG is extremely simple. Device manufacturers wishing to enter into the European device market must have a notified body. And under Annex XI of the Medical Device Directive, device manufacturers can take some comfort in knowing that notified bodies are also held to a high standard.

Continue reading