Regulatory Compliance for the UK Market
Medical Device Regulations UK
Since 1 January 2021, all medical devices and in vitro diagnostic medical devices (IVDs) placed on the UK market will need to be registered with the Medicines & Healthcare Products Regulatory Agency (MHRA). Manufacturers need to follow the UK Medical Device Regulations 2002 rules. The UK government is developing a more robust future medical devices regime, with key aspects expected to apply from 1 July 2025.
Due to Brexit, there have been a number of changes to how medical devices are placed on the market in Great Britain. Medical device manufacturers outside the UK will have to designate a UK Responsible Person.
The current UK route to market and UKCA marking follow the requirements derived from the EU legislation. A valid CE mark will allow the medical device during the transitional arrangements timeline to be sold in the UK market.
How long can a valid CE mark be sold in the UK?
A valid CE mark will allow the medical device to be sold in the UK market for the following periods:
- General medical devices that comply with the EU MDD or EU AIMDD and have a valid declaration and CE marking can be sold in Great Britain until the earlier of certificate expiry or 30 June 2028.
- IVDs that comply with the EU IVDD can be sold in Great Britain until the earlier of certificate expiry or 30 June 2030.
- General medical devices, including custom-made devices, that comply with the EU MDR and IVDs that comply with the EU IVDR can be sold in Great Britain until 30 June 2030.
UK market access transition timelines
Understanding the changes to the UK Regulations in the context of the EU transitions is an ongoing challenge. MHRA has issued new guidance, including handy infographics to help wrap your head around this tricky subject. Qserve closely follows the changes and developments in the UK market and regularly writes blogs and shares information to inform manufacturers and support them in the next steps.
Read Qserve's blog on the transition timelines and what this means for Medical Devices and In Vitro Diagnostics. There is detailed information on timelines for placing CE-marked IVDs and Medical Devices.
Medical Device Classification in the UK
Risk-based classification
The MHRA is responsible for classifying medical devices and IVDs in the UK according to their risk levels. Medical devices are divided into four
classes based on their risk:
- Class I: Low-risk devices, such as syringes
without needles and standard adhesive bandages.
- Class IIa: Lower medium-risk devices, such as
short-term corrective contact lenses and standard hearing aids.
- Class IIb: Higher medium-risk devices, such as
apnoea monitors and surgical lasers.
- Class III: High-risk devices, such as
pacemakers and breast implants.
Manufacturers must show that their device meets the UK requirements through a conformity assessment, which varies in depth depending on the device’s class. Manufacturers need to provide accurate and updated information to the MHRA and be ready to show more technical documents if requested.
In Vitro Diagnostics Classification in the UK
Perceived risk
The following categories classify IVDs according to the potential risk they pose to patient safety:
- General IVDs: These devices, not fitting into other categories, can be marketed by self-declaring compliance without third-party assessment.
- IVDs for Self-Testing: These devices, except for certain self-test medical ones, are designed for home use by laypersons.
- IVDs in Annex II List B: This category includes reagents and products for diseases like rubella, toxoplasmosis, and phenylketonuria, along with medical devices for self-testing blood glucose levels.
- IVDs in Annex II List A: This covers reagents and products for HIV I and II, Hepatitis B, C, and D, blood group determinants like ABO systems and anti-kell, including tests for donated blood and screening.
The MHRA is reviewing the IVD classification rules to increase the level of scrutiny applied to IVD devices, reflecting the rapid developments and innovation in the field of IVDs.