EU & UK Medical Device Legislation Guidelines
On 5th April 2017, two new EU Regulations on medical devices were adopted, and entered into force on 25th May 2017 replacing the existing medical device directives.
- 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
As the UK is no longer an EU entity, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has taken over implementing the UK bill for medical devices.
To keep up with the legislative changes in medical devices, PIPA has created two guidance documents on the EU and UK Medical Device legislation:
UK Medical Device Vigilance Guidelines