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 |
| Regulation | Transitional Provisions (2023/607) – Amending Regulations (EU) 2017/745 and (EU) 2017/746 | Link |
| Implementing Regulation | Rules for E-Labeling under EU 2017/745 (MDR) | 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) | Link |
| Guidance | Guidance on general principles of clinical evidence for IVDs (MDCG 2022-2) | Link |
| Guidance | Guidance on significant changes regarding the transitional provision under Article 120 of the MDR with regard to devices covered by certificates according to MDD or AIMDD (MDCG 2020-3) | Link |
| Guidance | Guidance on significant changes regarding the transitional provision under Article 110(3) of the IVDR (MDCG 2022-6) | 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 |
| Guidance | Questions and Answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 on medical devices (MDCG 2023-3) | Link |
| Guidance | Guidance on Periodic Safety Update Report (PSUR) according to Regulation (EU) 2017/745 (MDCG 2022-21) | Link |
| Q&A Document | Q&A on practical aspects related to the implementation of Regulation (EU) 2023/607 – Extension of the MDR transitional period and removal of the “sell off” periods | 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 | Best Practice Guidance for the Submission of Technical Documentation under Annex II and III of Medical Device Regulation (EU) 2017/745 (Team Notified Body) | 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 |
| Reference Guide | MORE Vigilance Portal – User Reference Guide | 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 |
