Regulations and Guidances

Quick access to regulations, guidances, and other helpful links for Europe, the United Kingdom and Switzerland

Europe

Type
Description
Link
Regulation Medical Device Regulation (MDR) 2017/745 Link
Regulation In-Vitro Diagnostic Regulation (IVDR) 2017/746 Link
Guidance Guidance on clinical evaluation – Equivalence (MDCG 2020-5) Link
Guidance Guidance on classification of medical devices (MDCG 2021-24) Link
Guidance Guidance on Classification Rules for IVDs under Regulation (EU) 2017/746 (MDCG 2020-16 Rev.1) Link
Guidance Guidance on general principles of clinical evidence for IVDs (MDCG 2022-2) Link
Guidance Guidance on PMCF evaluation report template (MDCG 2020-8) Link
Guidance Guidance on PMCF plan template (MDCG 2020-7) Link
Guidance Regulation (EU) 2017/746 – application of IVDR requirements to ‘legacy devices’ and to devices placed on the market prior to 26 May 2022 in accordance with Directive 98/79/EC (MDCG 2022-8) Link
Guidance Q&A on the Unique Device Identification system under Regulation (EU) 2017/745 and Regulation (EU) (MDCG 2022-7) Link
Manual Manual on borderline and classification for medical devices under Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices Link
Position Paper Transition to the MDR and IVDR – Notified body capacity and availability of medical devices and IVDs (MDCG 2022-14) Link
EUDAMED EUDAMED ‘Restricted’ (site you should use to register) Link
EUDAMED EUDAMED Public Database Link
EUDAMED EUDAMED ‘Playground/sandbox’ Link
UDI EU UDI Helpdesk Link
UDI UDI/Devices User Guide Link
EMDN Codes EMDN database Link

United Kingdom

Type
Description
Link
Regulation The Medical Devices Regulations 2002 Link
Regulation The Medical Devices (Amendment etc.) (EU Exit) Regulations 2020 Link
Guidance Regulating Medical Devices in the UK Link
Consultation Consultation on the future regulation of medical devices in the United Kingdom Link
Guidance Guidance on Class I medical devices Link
Guidance Medical devices: conformity assessment and the UKCA mark Link
Guidance Register medical devices to place on the market Link
Guidance Medical devices: EU regulations for MDR and IVDR (Northern Ireland) Link
Guidance Medical devices: guidance for manufacturers on vigilance Link

Switzerland

Type
Description
Link
Regulation Medical Devices Ordinance (MedDO) Link
Regulation IVD Ordinance (IvDO) Link
Regulation Therapeutic Products Act, TPA Link
Help Guide Obligations of Economic Operators Link
Help Guide Swiss Single Registration Number (CHRN) Link
Agreement Mutual Recognition Agreement between Switzerland and EU (‘Bilateral Agreement I’) Link
Labeling Swiss Authorized Representative symbol Link
Webpage Vigilance relating to medical devices Link