Laws and Regulations
The BfArM provides an overview of the most relevant European and national regulations for Medical Devices and the national laws for digital applications.
This is not an exhaustive overview of the requirements that have to be met by economic operators.
No liability is assumed for the following legal texts with regard to authenticity and up-to-dateness. The exclusion of liability also applies to the text transmitted in data form and printed out.
Please note that the national laws are only available in German!
Medical devices
European regulations
European regulations
- Regulation (EU) 2017/745 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
- Regulation (EU) 2017/746 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU
- Regulation (EU) 2023/607 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices
- Commission implementing regulation (EU) 2022/2346 laying down common specifications for the groups of products without an intended medical purpose listed in Annex XVI to Regulation (EU) 2017/745
- Regulation (EU) No 722/2012 concerning particular requirements as regards the requirements in Directives 90/385/EEC and 93/42/EEC with respect to active implantable medical devices and medical devices manufactured utilising tissues of animal origin
Guidance of the Medical Device Coordination Group (MDCG) on the implementation of MDR and IVDR
National legislation
National ordinances
- Verordnung über die Meldung von mutmaßlichen schwerwiegenden Vorkommnissen bei Medizinprodukten sowie zum Informationsaustausch der zuständigen Behörden (Medizinprodukte-Anwendermelde- und Informationsverordnung, MPAMIV)
- Besondere Gebührenverordnung des Bundesministeriums für Gesundheit für die individuell zurechenbaren Leistungen in seinem Zuständigkeitsbereich (Besondere Gebührenverordnung BMG - BMGBGebV)
- Verordnung über das Errichten, Betreiben und Anwenden von Medizinprodukten (Medizinprodukte-Betreiberverordnung - MPBetreibV)
- Verordnung zur Regelung der Abgabe von Medizinprodukten (Medizinprodukte-Abgabeverordnung - MPAV)