Regulations
NIS 2 Directive
Medical device industry
- Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 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 (Text with EEA relevance)Text with EEA relevancego
- Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (Text with EEA relevance. )go
- A set of regulations applicable to manufacturers, suppliers, and distributors of medical devices in the EU marketgo
- FDA - U.S. legal requirements for medical devices (regulations applicable to companies supplying products, components, or services to the U.S. market)go
- EUDAMED - European Database on Medical Devicesgo