Regulations applying to medical devices
Each entry states what the text requires, which classes it applies to, since when, and links to its official source. Statements are verified against the primary text.
Founding texts
The EU regulations and their structuring articles: what binds you, and directly.
- MDR 2017/745Regulation (EU) 2017/745 on medical devices
- MDR Art. 10General obligations of manufacturers
- MDR Art. 52Conformity assessment procedures
- MDR Art. 61Clinical evaluation and clinical investigations
- MDR Art. 120Transitional provisions
- MDR Art. 29 et 31Registration of devices and economic operators in EUDAMED
- MDR Art. 27Unique Device Identification system (UDI)
- MDR Annexe IGeneral safety and performance requirements
- MDR Annexe VIIIClassification rules
- IVDR 2017/746Regulation (EU) 2017/746 on in vitro diagnostic medical devices
- IVDR Art. 47Classification of in vitro diagnostic devices
- IVDR Art. 56Performance evaluation
- IVDR Art. 57 à 77Performance studies
- MDR Art. 15Person responsible for regulatory compliance
Harmonised standards
The standards that grant a presumption of conformity. Following them is not mandatory; departing from them requires a written justification.
- ISO 13485:2016Medical devices — Quality management systems
- ISO 14971:2019Application of risk management to medical devices
- IEC 62304:2006Medical device software — Software life cycle processes
- IEC 60601-1:2020Medical electrical equipment — Basic safety and essential performance
- ISO 10993 (série)Biological evaluation of medical devices
- ISO 14155:2020Clinical investigation of medical devices for human subjects
- IEC 62366-1:2015Medical devices — Application of usability engineering
- ISO 15223-1:2021Symbols to be used with information supplied by the manufacturer
- ISO 11135:2014Sterilization of health care products — Ethylene oxide
- ISO 11737-1:2018Sterilization of health care products — Microbiological methods
- ISO 13408-1:2023Aseptic processing of health care products
- ISO 80369 (série)Small-bore connectors for liquids and gases
- IEC 62366-2:2016Application of usability engineering — Part 2
MDCG guidance
The coordination group’s guidance. Not binding, but what notified bodies apply.
Post-market
What begins once the device is on the market: surveillance, periodic reports, vigilance.
National requirements
What each country adds to the European baseline: registration, language, contact points.
- FR-ANSM-NOTIFANSM notification (France)
- FR-LANGUEFrench language requirement (France)
- DE-BFARM-REGBfArM registration (Germany)
- DE-MPDGMedizinprodukterecht-Durchführungsgesetz (Germany)
- IT-MIN-SALUTEMinistry of Health registration (Italy)
- IT-NSISNSIS repository (Italy)
- ES-AEMPS-REGAEMPS registration (Spain)
- ES-LANGUESpanish language requirement (Spain)
- CH-SWISSMEDIC-REGRegistration of the economic operator with Swissmedic
- CH-MANDATAIRESwiss authorised representative required