Medical Devices in the UK: New Guide for Manufacturers

Understanding the UK Medical Device Regulations

Following the UK’s exit from the EU, the regulation of medical devices, in vitro diagnostic (IVD) devices, and active implantable medical devices (AIMDs) in Great Britain (England, Scotland, and Wales) is governed by the UK Medical Devices Regulations 2002 (UK MDR 2002).

Although based on previous EU Directives, the UK has introduced post-Brexit changes, including the UK Conformity Assessed (UKCA) mark, which will replace the CE mark for Great Britain. CE marking is still accepted until July 2025, after which the UKCA mark will become mandatory.

In Northern Ireland, however, the EU CE mark and EU MDR/IVDR continue to apply under the Northern Ireland Protocol.

Role of the MHRA in UK Medical Device Regulation

The Medicines and Healthcare products Regulatory Agency (MHRA) is the UK’s regulatory body responsible for ensuring that medical devices comply with safety and performance requirements.

Key responsibilities of the MHRA include:

✅ Overseeing the registration and approval of medical devices.
✅ Managing post-market surveillance and vigilance reporting.
✅ Investigating safety concerns and enforcing corrective actions.
✅ Setting rules for labeling, market placement, and advertising.

Manufacturers must register their devices with MHRA before placing them on the Great Britain market.

Device Classification and Compliance Requirements

Medical devices are classified based on risk levels, following a structure similar to the EU MDR and IVDR:

Class I (low risk) – Bandages, surgical gloves, non-sterile instruments.
Class IIa (medium risk) – Infusion pumps, dental fillings.
Class IIb (higher risk) – Ventilators, orthopedic implants.
Class III (high risk) – Pacemakers, heart valves, implantable devices.
IVD Devices – Diagnostic tests, blood glucose monitors, pregnancy tests.

Each classification has different compliance obligations, including technical documentation, clinical evaluation, and conformity assessment procedures.

CE Marking: What Manufacturers Need to Know

MHRA will accept CE marked devices on the Great Britain market until, at the latest, 30 June 2030 depending on device type and classification.

You can place a Class I medical device which has a sterile or measuring function with a valid MDD certificate on the GB market until 30 June 2028.

Registering medical devices which the EU MDR upclassifies from Class I and that are EU MDD Class I reusable surgical instruments

EU MDD Class I reusable surgical instruments that would require notified body involvement in their assessment under EU MDR
EU MDD Class I medical devices that are upclassified under and require notified body involvement pursuant to the EU MDR

How to Register Medical Devices with the MHRA

All medical devices, IVDs, and custom-made devices must be registered with MHRA before they can be sold in Great Britain.

Key Registration Steps:

1️⃣ Determine the device classification based on UK MDR 2002.
2️⃣ Prepare technical documentation demonstrating safety and performance.
3️⃣ Obtain conformity assessment certification (if required) through a UK Approved Body.
4️⃣ Register with MHRA using the online portal.
5️⃣ Maintain post-market surveillance and report adverse events.

The Role of a UK Responsible Person (UKRP) for Non-UK Manufacturers

If a manufacturer is not based in the UK, they must appoint a UK Responsible Person (UKRP) to register their devices with MHRA.

UKRP Responsibilities Include:

✅ Submitting the device registration to MHRA.
✅ Ensuring the manufacturer meets UK compliance obligations.
✅ Holding and verifying technical documentation.
✅ Acting as the main contact for MHRA regarding audits and post-market surveillance.

AF Pharma provides cost-effective UKRP services, helping non-UK manufacturers seamlessly enter the UK market while ensuring full regulatory compliance.

Conclusion: Ensuring Compliance in the UK Market

Understanding UK medical device regulations is essential for manufacturers looking to sell their products in Great Britain.

With UK MDR 2002, MHRA oversight, and the transition to UKCA marking, businesses must stay ahead of regulatory changes to avoid market disruptions.

For non-UK manufacturers, partnering with a trusted UKRP like AF Pharma can simplify compliance and streamline the registration process.

📩 Need UK regulatory support? Contact us at www.afpharmaservice.com.