UK IVD Registration: Key Updates for Manufacturers with Expiring CE Certificates
New MHRA guidance on in vitro diagnostic (IVD) device registration in the UK
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has issued updated guidance on the registration of in vitro diagnostic (IVD) devices with expiring CE certificates. These new measures outline how manufacturers can maintain market access in the UK while ensuring compliance with evolving regulatory requirements.
If your IVD devices are affected by these changes, it’s crucial to take action before your CE certificate expires to avoid disruptions in distribution.
What has changed?
The UK government has introduced specific conditions for IVDs benefiting from the EU IVDR transitional extension. If your IVDs fall under this category, you may still be able to register and market them in the UK, but compliance with updated regulations is essential.
Key points for manufacturers
1️⃣ IVDs with extended CE certificates may remain on the UK market
- Devices covered by the EU IVDR transition period can continue to be marketed in the UK under specific conditions.
- The full MHRA guidance on IVD registration provides detailed instructions.
2️⃣ Compliance with new UK regulations is mandatory
- Manufacturers must ensure their devices meet the UK regulatory framework to maintain validity.
- The MHRA has introduced specific registration and compliance conditions for affected devices.
3️⃣ Deadlines matter: Certificates expiring on or after July 9, 2024, require action
- Manufacturers must update their registration with MHRA before their certificate expires.
- Registrations must be submitted through DORS (Device Online Registration System) to ensure continued market access.
Need a UK Responsible Person (UK RP)? We can help!
Non-UK manufacturers are required to appoint a UK Responsible Person (UK RP) to register and maintain compliance for their devices in the UK market.
As your trusted UK RP, we provide:
✔ Complete MHRA registration services for medical devices and IVDs
✔ Ongoing regulatory compliance support to ensure seamless market access
✔ Expert guidance on UK MDR and IVDR requirements
How to stay compliant
To maintain your presence in the UK market, take these proactive steps:
✔ Identify affected devices: Review your IVD portfolio to determine which products require registration updates.
✔ Register or update your devices in MHRA’s system: Ensure all required documentation is submitted through DORS before deadlines.
✔ Appoint a UK Responsible Person (UK RP): If you are a non-UK manufacturer, you must have a designated UK RP to handle compliance.
✔ Monitor regulatory changes: Stay informed on updates from the MHRA to avoid compliance risks.
Need Help with UK IVD registration?
Ensuring compliance with MHRA’s evolving regulations is crucial for manufacturers looking to maintain access to the UK market. If you need support with IVD registration, UK RP services, or guidance on compliance strategies, our regulatory experts are here to help.
Contact us today to ensure your IVD devices remain compliant and available in the UK.
