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Conformity assessment procedures for protective equipment
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
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
ATEX 2014/34/EU Guidelines
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
Clarifications on the initiative of upload of software into radio equipment
Guidance on medical devices, active implantable medical devices and in vitro diagnostic medical devices in the COVID-19 context
Guidance on the applicable legislation for leave-on hand cleaners and hand disinfectants (gel, solution, etc.)
Smart Guide to cluster policy monitoring & evaluation
MDCG 2020-1 Guidance on Clinical Evaluation (MDR) / Performance Evaluation (IVDR) of Medical Device Software
MDCG 2020-2 Class I Transitional provisions under Article 120 (3 and 4) – (MDR)
MDCG 2019-8 v2 - Guidance document - Implant Card relating to the application of Article 18 Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices
MDCG 2018-1 v3 Guidance on BASIC UDI-DI and changes to UDI-DI
User guide for Directive 2005/36/EC on recognition of professional qualifications
Clarifications and Resolutions of the Forum of Notified Bodies
Guide to application of the Machinery Directive 2006/42/EC - Edition 2.2
Guidance on the participation of third-country bidders and goods in the EU procurement market
Guidelines on the exemption procedure for the EU approval of automated vehicles
Transition Timelines from the Directives to the Regulations - Medical Devices and in vitro Diagnostic Medical Devices
Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR) - infographics
Factsheet for the Procurement Ecosystem of Medical Devices and in vitro Diagnostic Medical Devices
Factsheet for Authorities in non-EU/EEA States on Medical Devices and in vitro Diagnostic Medical Devices
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