Navigation path

Unique Device Identification (UDI) System - FAQs
Conformity assessment procedures for protective equipment
Declaration of interest (DOI) form - Call for expression of interest for expert panels on medical devices and in vitro diagnostic medical devices (2019/C 323/05)
Manufacturer incident report 2020
Manufacturer incident report for importing XML file with Adobe Professional 2020
MDCG 2020-12 Transitional provisions for consultations of authorities on devices incorporating a substance which may be considered a medicinal product [...] as well as on devices manufactured using TSE susceptible animal tissues
MDR and IVDR implementing measures rolling plan
Planned meetings of Medical Device Coordination Group (MDCG) and subgroups in 2020
MDCG 2020-11 Guidance on the renewal of designation and monitoring of notified bodies under Directives 90/385/EEC and 93/42/EEC to be performed in accordance with Commission Implementing Regulation (EU) 2020/666 amending Commission Implementing Regulatio
Amendment to Implementing Regulation 920/2013 on the designation of notified bodies
Questions and Answers document regarding the Implementation of the new Manufacturer Incident Report (MIR) Form
Commission Guidelines on Union-wide derogations for medical devices
How to verify that medical devices and personal protective equipment can be lawfully placed on the EU market and thus purchased and used – also in the COVID-19 context
Changelog file 2020
MDCG 2020-10/1 Safety reporting in clinical investigations of medical devices under the Regulation (EU) 2017/745
Results per page: 5 10 15 20 25 | Page 1 out of 19

Additional tools