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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
Planned meetings of Medical Device Coordination Group (MDCG) and subgroups in 2020
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
Manufacturer incident report for importing XML file with Adobe Professional 2020
Manufacturer incident report 2020
Changelog file 2020
MDCG 2020-10/1 Safety reporting in clinical investigations of medical devices under the Regulation (EU) 2017/745
MDCG 2020-10/2 Clinical Investigation Summary Safety Report Form v1.0
Ongoing Guidance development within MDCG Subgroups
Privacy statement - Call for expression of interest for expert panels on medical devices and in vitro diagnostic medical devices (2019/C 323/05)
MDCG 2020-9 Regulatory Requirements for Ventilators and Related Accessories
MDCG 2020-5 Clinical Evaluation - Equivalence. A guide for manufacturers and notified bodies
MDCG 2020-6 Regulation (EU) 2017/745: Clinical evidence needed for medical devices previously CE marked under Directives 93/42/EEC or 90/385/EEC. A guide for manufacturers and notified bodies
MDCG 2020-7 Post-market clinical follow-up (PMCF) Plan Template. A guide for manufacturers and notified bodies
MDCG 2020-8 Post-market clinical follow-up (PMCF) Evaluation Report Template. A guide for manufacturers and notified bodies
Current performance of COVID-19 test methods and devices and proposed performance criteria - Working document of Commission services
Guidance on temporary extraordinary measures related to medical device Notified Body audits during COVID-19 quarantine orders and travel restrictions
MDCG 2019-3 Interpretation of Article 54(2)b rev 1
Guidance on medical devices, active implantable medical devices and in vitro diagnostic medical devices in the COVID-19 context
IMDRF Standards Checklist modified in scope of COVID-19
Conformity assessment procedures for protective equipment
State of play of joint assessments of Notified Bodies in the medical device sector
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