delete Amendments to Medical Devices Regulations 2002
Post-Brexit amendment statutory instrument that modifies the Medical Devices Regulations 2002 and four EU tertiary legislative instruments concerning medical devices (in vitro diagnostics, electronic instructions for use, active implantable devices using animal tissues, and notified body designation). Applies to England, Wales and Scotland only. Primarily technical corrections to ensure EU-derived law functions correctly after UK left the EU.
This instrument perpetuates retained EU medical device law without meaningful reform. The EU exit provided an opportunity to reassess whether these technical specifications, notified body requirements, and approval processes serve British patients and industry well. Instead of using post-Brexit autonomy to reduce regulatory burden and streamline device approval, the UK largely transposed the EU framework. The regulation adds compliance costs with no corresponding benefit beyond maintaining the status quo — exactly the kind of regulatory inertia Adam Smith and the free traders would caution against. The UK's medical device approval process should compete globally, not merely replicate EU bureaucracy.