The Medical Device Coordination Group (MDCG) has published a Q & A on the Medical Devices Regulation (EU) 2017/745/ (MDR) regarding clinical investigation.
The document MDCG 2021-6 is entitled ‘Regulation (EU) 2017/745 – Questions & Answers regarding clinical investigation’.
Who is the document for?
It is intended for sponsors of clinical investigations of medical devices conducted within the scope of the Regulation (EU) 2017/745 (MDR).
About the questions in the document
The 19 page document has 28 Q & As. The document may be supplemented in due course with further questions and answers.
The questions in the document are split under the following headings:
- General questions
- Modifications to clinical investigations
- Timeline considerations for clinical investigations
- Clinical investigation reports
- Arrangements for the transitional period
The first five questions in the document are:
- What are the general differences and improvements related to clinicalinvestigations under the new Regulation (EU) 2017/745 (MDR) as compared to the Directives 93/42/EEC and 90/385/EEC?
- What is a clinical investigation?
- What is the difference between the performance, clinical performance and clinical benefit?
- Which regulatory pathway shall a sponsor follow in order to conduct a clinical investigation to collect clinical data that will be used to support the conformity assessment procedure of the investigated medical device?
- What is a pilot clinical investigation?
This document should prove to be quite useful for anyone wanting to get a basic and clear understanding on the subject of clinical investigations with medical devices.
Source: Europa website.