Differences between UK MDR and EU MDR

Learn the differences between UK medical device regulation (UK MDR) and EU medical device regulation (EU MDR). The below covers the various aspects including scope, regulatory requirements, conformity assessment, and transitional arrangements.

Comparison table: UK MDR and EU MDR

	UK MDR	EU MDR
Scope and Application	Applies only to the UK market (England, Scotland, Wales)	Applies to all member states in the EU (and Northern Ireland)
Devices Covered	Covers medical devices and in-vitro diagnostic devices	Applies only to medical devices
Nomenclature	Uses GMDN nomenclature	Uses EMDN nomenclature
Marking	Requires the UKCA mark	Requires the CE mark
Clinical Investigations	Must comply with UK guidance on legislation	Must be conducted in line with specific articles
Transition Period	Offers a grace period for compliance with UK standards until June 30, 2023	Had a transition period that ended in May 2021
Notified Body Designation	UK Approved Bodies (England, Scotland, Wales)	Designated by competent authorities in EU member states (and Northern Ireland)
Regulatory Evolution	Evolved from EU regulations	Replaced the Medical Devices Directive with significant changes

FAQ

What are the main differences between the UK MDR and EU MDR in terms of scope and application?

The UK MDR applies only to the UK market, including England, Scotland, and Wales, while the EU MDR applies to all EU member states and Northern Ireland.

Which devices are covered under the UK MDR and EU MDR?

The UK MDR covers both medical devices and in-vitro diagnostic devices. In contrast, the EU MDR applies only to medical devices.

What nomenclature do the UK MDR and EU MDR use?

The UK MDR uses the Global Medical Device Nomenclature (GMDN), while the EU MDR uses the European Medical Device Nomenclature (EMDN).

What markings are required under the UK MDR and EU MDR for medical devices?

Devices under the UK MDR must have the UKCA mark, whereas devices under the EU MDR need to carry the CE mark.

How do clinical investigations differ between the UK MDR and EU MDR?

Under the UK MDR, clinical investigations must comply with UK-specific guidance on legislation, while the EU MDR requires investigations to be conducted in line with specific articles outlined within the regulation.

Is there a transition period for compliance with the UK MDR and EU MDR?

Yes, the UK MDR offered a grace period for compliance until June 30, 2023. The EU MDR had a transition period that ended in May 2021.

How are notified bodies designated under the UK MDR and EU MDR?

For the UK MDR, notified bodies are designated as UK Approved Bodies for England, Scotland, and Wales. In the EU MDR, notified bodies are designated by competent authorities in EU member states and Northern Ireland.

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