Department of Biomedicine

Legislation in the field of biomedicine and alternative toxicological methods

Medical devices

Overview – European Medicines Agency

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

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

ISO 10993 – Biological evaluation of medical devices

Part 1: Evaluation and testing within a risk management process

Part 2: Animal welfare requirements

Part 5: Tests for in vitro cytotoxicity

Part 10: Tests for skin sensitization

Part 12: Sample preparation and reference materials

Part 23: Tests for irritation

Chemicals

Overview – European Commission

Cosmetics

Overview – European Commission

Toys