Medical devices

Medical devices

Until the application of a new regulatory framework for the EU beginning from 26 May 2021, the regulatory framework in the EU for medical devices, active implantable medical devices (AIMDs), and in vitro diagnostic medical devices (IVDs) consisted of:

1. •

   Directive 93/42/EEC on medical devices

2. •

   Directive 90/385/EEC on active implantable medical devices

3. •

   Directive 98/79/EC on in vitro diagnostic medical devices

These MD Directives remain relevant to ‘legacy’ devices and those that were placed on the market before applicable deadlines for certain devices to transition to the new EU regulations. However, all devices must comply with certain increased obligations of compliance under the new EU medical devices regulatory regime. See Practice Note: An introduction to the regulation of medical devices—EU Directives regime.

In the UK, the MD Directives have been implemented via the Medical Devices Regulations 2002 (MDR 2002), SI 2002/618, which were issued under the Consumer Protection Act 1987. The Medicines and Healthcare products Regulatory Agency (MHRA) is the UK competent authority responsible for supervision of medical device regulation. The end of the Brexit transition period