Communication Campaign’ of the European Commission – factsheets and infographics supporting IVDR/MDR implementation

Posted on 06.12.2018

European Commission published a series of factsheets and infographics as part of their ‘Communications Campaign’ on the In vitro Diagnostic Medical Device Regulation (EU) 2017/746 (IVDR) and Medical Device Regulation (EU) 2017/745 (MDR). We expect more documents to be published in the future such as translations of the below documents into additional languages and other factsheets for healthcare professionals and patients.
1. Factsheet for IVD Manufacturers
2. Factsheet for MD Manufacturers
3. Implementation Model for IVDR – Step by Step Guide
4. Implementation Model for MDR – Step by Step Guide
5. Transition Timelines from the Directives to the Regulations – MDs and IVDs
6. MDR and IVDR – infographics
7. Factsheet for Authorised Representatives, Importers and Distributors of MDs and IVDs
8. Factsheet for Authorities in non-EU/EEA States on MDs and IVDs
9. Factsheet for the Procurement Ecosystem of MDs and IVDs