Medical devices

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:

•
Directive 93/42/EEC on medical devices
•
Directive 90/385/EEC on active implantable medical devices
•
Directive 98/79/EC on in vitro diagnostic medical devices

In the UK, the MD Directives have been implemented via the Medical Devices Regulations 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 has brought changes to the UK regime.

In the EU, the above directives are replaced by two regulations:

•
Regulation (EU) 2017/745, the Medical Devices Regulation or MDR, which

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