UK Market Access for Medical Devices and IVDs
Navigating Regulatory Compliance for the UK Market
Entering the UK market with your medical or in vitro diagnostic devices (IVDs) requires compliance with stringent regulations. Since January 1, 2021, all medical devices and IVDs sold in the UK must be registered with the Medicines & Healthcare Products Regulatory Agency (MHRA). To meet these requirements, manufacturers must adhere to the UK Medical Device Regulations 2002 and obtain the UKCA Marking certification.
The UK’s exit from the EU has introduced new regulations for placing medical devices in Great Britain. Non-UK manufacturers must appoint a UK Responsible Person (UKRP). Acting on their behalf, the UKRP ensures that their products comply with all UK regulatory standards, enabling smooth market access and avoiding unnecessary delays.
During the transitional period, devices with a valid CE Mark may still be sold in the UK. However, this is set to change as the UK transitions to a more robust regulatory regime. The UK government is rolling out a new medical devices regime starting July 1, 2025. This new framework will replace EU-derived requirements with an enhanced system to ensure greater safety and efficiency. Staying ahead of these changes is critical to maintaining market access and ensuring compliance with evolving standards.
UK REGULATORY COMPLIANCE AND REGISTRATION SUPPORT
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How long can a valid CE mark be sold in the UK?
Understanding how long CE-marked medical and in vitro diagnostic devices (IVDs) can be sold in the UK is critical for manufacturers navigating post-Brexit regulations. At the same time, the UK transitions to its certification system, the UKCA marking. CE marks are temporarily allowed under specific conditions and deadlines.
Key Deadlines for CE-Marked Devices in the UK
- General Medical Devices (EU MDD or EU AIMDD): You can sell these devices in the UK until June 30, 2028, or until the certificate expires, whichever comes first.
- IVDs (EU IVDD): These devices are allowed on the UK market until June 30, 2030, or until the certificate expires, whichever comes first.
- General Medical Devices (EU MDR) and IVDs (EU IVDR): These devices can remain on the UK market until June 30, 2030, regardless of certificate expiry dates.
What Does This Mean for Manufacturers?
If you plan to continue selling in the UK after these deadlines, you must transition to UKCA marking, which is required for most medical devices and IVDs in Great Britain. Acting now ensures you meet the deadlines and avoid disruptions to your market access.
What Is UKCA Marking?
The UKCA marking (UK Conformity Assessed) is the UK’s certification for medical devices, replacing the EU’s CE mark. This certification demonstrates that your product complies with the UK Medical Device Regulations 2002. Key requirements include:
- Registering your device with the Medicines & Healthcare Products Regulatory Agency (MHRA).
- Meeting updated safety and performance standards outlined by UK regulations.
Transitioning from CE to UKCA marking takes time. By starting the process now, you avoid last-minute delays, ensure compliance, and secure access to the UK market well before the deadlines.
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UK market access transition timelines
Staying compliant with UK medical device and in vitro diagnostic device (IVD) regulations can feel overwhelming, especially with ongoing changes due to Brexit. Manufacturers must remain proactive to maintain market access for key deadlines, transitional arrangements, and evolving requirements. Here’s a simplified overview of the latest updates and what they mean for your business.
Key Updates for IVDs
- CE Certificates Expiry for IVDD Devices
All IVDD CE certificates will expire no later than May 26, 2025. After this date, these certificates will no longer grant access to the UK market. Manufacturers must transition their devices to the IVDR or obtain a UKCA certificate through a UK Approved Body.
- General IVDs Transition Period
General IVDs under IVDD with a declaration of conformity made before May 26, 2022, can continue to use this declaration for UK market access until June 30, 2030. Manufacturers must use the UKCA route for new devices and complete their declaration under the UK Medical Device Regulations 2002 by June 30, 2025.
- Class C Devices (Example: Rubella Tests)
Class C devices transitioning from Annex II List B under IVDD must move to IVDR or secure a UKCA certificate by May 26, 2025.
Key Updates for Medical Devices
- Class I Devices
- Class I devices self-declared under the EU MDD can remain on the UK market until June 30, 2028, provided their declaration of conformity was signed before May 26, 2021. Afterward, an EU MDR certificate will be required.
- Based on their EU MDR declaration, Class I devices that do not need a notified body under the EU MDR can remain on the market until June 30, 2030.
- Higher-Risk Devices (Class IIb and III)
Class III and IIb implantables with valid MDD certificates can stay on the UK market until December 31, 2027. Devices CE-marked under the EU MDR can remain until June 30, 2030, before requiring UKCA certification.
- Northern Ireland Differences
Northern Ireland has slightly different timelines. For example, Class IIa MDD devices are allowed in Great Britain until June 30, 2028, but only until December 31, 2028, in Northern Ireland.
Understanding the timelines and requirements is crucial to avoid disruptions and maintain compliance.
The full blog on UK market access provides detailed information, including insights into specific classes of devices and infographics to simplify the rules.
Medical Device Classification in the UK
Risk-based classification
Navigating the UK regulatory landscape for medical and in vitro diagnostic devices (IVDs) starts with understanding how the Medicines and Healthcare Products Regulatory Agency (MHRA) classifies these devices. The MHRA uses a risk-based classification system to ensure that every device meets safety and performance standards appropriate to its level of risk.
- Class I: Low-Risk Devices
- Examples: Adhesive bandages and syringes without needles.
- Regulatory Requirements: Minimal scrutiny, but manufacturers must still demonstrate compliance with essential requirements and maintain technical documentation.
- Class IIa: Lower Medium-Risk Devices
- Examples: Short-term corrective contact lenses and hearing aids.
- Regulatory Requirements: Moderate oversight to ensure safe and effective performance for their intended use.
- Class IIb: Higher Medium-Risk Devices
- Examples: Apnoea monitors and surgical lasers.
- Regulatory Requirements: These devices pose greater risks due to their complexity and usage scenarios, requiring more extensive review.
- Class III: High-Risk Devices
- Examples: Pacemakers and breast implants.
- Regulatory Requirements: The highest level of scrutiny, including rigorous evaluation of clinical evidence and performance data.
Regardless of the classification, manufacturers must:
- Prove that their devices comply with UK Medical Device Regulations and essential safety standards.
- Submit updated technical files and declarations of conformity to the MHRA.
- Prepare to provide additional information or undergo inspections if requested by the MHRA.
For higher-risk devices (Classes IIb and III), the depth of the assessment is more extensive, requiring clinical evidence, risk management documentation, and potentially the involvement of a UK-approved body.
In Vitro Diagnostics Classification in the UK
Perceived risk
The UK classifies in vitro diagnostic devices (IVDs) based on the level of risk they pose to patient safety. These classifications determine the regulatory requirements for placing IVDs on the UK market. Whether your device is a general IVD or a high-risk diagnostic tool, understanding its classification is critical for ensuring compliance and patient safety.
Risk-Based IVD Classification
- General IVDs
- Definition: Low-risk devices where manufacturers self-declare compliance without needing third-party assessment.
- Examples: Laboratory reagents not tied to specific critical tests.
- IVDs for Self-Testing
- Definition: Devices designed for home use by non-professionals, helping individuals monitor their health.
- Exclusions: Some self-test medical devices fall outside this category and require additional scrutiny.
- Examples: Pregnancy tests and cholesterol monitoring kits.
- IVDs in Annex II List B
- Definition: Medium-risk IVDs are used for detecting certain diseases and conditions requiring higher scrutiny than general IVDs.
- Examples: Reagents for rubella, toxoplasmosis, phenylketonuria, and self-testing blood glucose devices.
- IVDs in Annex II List A
- Definition: High-risk IVDs are crucial for diagnosing serious diseases, ensuring blood safety, and preventing infectious disease transmission.
- Examples: Reagents for HIV I/II, Hepatitis B/C/D, blood group determinants, and tests for screening donated blood.
The MHRA is reviewing IVD classification rules to increase scrutiny and adapt to rapid advancements in the field. With emerging technologies and evolving healthcare needs, stricter classifications aim to ensure safety and reliability across all IVD categories.
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