Since the introduction of the medical device regulation in the 90ies, the Technical Documentation had a central role in medical device compliance. It is the basis for conformity assessment and therefore essential for the marketing of the product. The still effective Medical Device Directive specifies only a few concrete requirements regarding the content of the Technical Documentation. A Notified Body recommendation, which is more specific, dates back to 2000.
The Medical Device Regulation (MDR) now specifies the requirements for the Technical Documentation in much detail in Annex II. Annex III then addresses the Technical Documentation in the context of Post Market Surveillance (PMS). Due to postponement of the effectiveness of the MDR to 26 May 2021, there is now one more year to comply with these new requirements.