Navigating UK MHRA Guidance: Registration and Regulation of Medical Devices in the UK

The Medicines and Healthcare Products Regulatory Agency (MHRA) oversees the regulation and registration of medical devices within the United Kingdom. Ensuring compliance with MHRA guidelines is essential for manufacturers aiming to market their devices in Great Britain and Northern Ireland. This article consolidates key aspects from three pivotal MHRA guidance documents that were recently updated

1. Register medical devices to place on the market

2. Regulating medical devices in the UK

3. Registration of in vitro diagnostic devices with expiring CE certificates

   

Guidance: Registering Medical Devices in the UK

Before placing any medical device on the market in Great Britain (England, Wales, and Scotland), manufacturers must register the device with the MHRA. This requirement encompasses all medical devices, including in vitro diagnostic devices (IVDs), custom-made devices, and systems or procedure packs. This guidance details How to register your medical devices with the Medicines and Healthcare products Regulatory Agency (MHRA) for the markets in Great Britain and Northern Ireland.

Key Registration Requirements:

• UK Responsible Person: Non-UK manufacturers must appoint a UK Responsible Person to act on their behalf in carrying out specified tasks, including device registration.

• Registration Timing: Devices must be registered with the MHRA before being placed on the Great Britain market. Failure to register prohibits lawful market placement.

• Information Accuracy: Manufacturers are responsible for ensuring that all information provided to the MHRA is accurate and up-to-date.

Guidance: Regulatory Framework for Medical Devices

The MHRA is the competent authority responsible for regulating the UK medical devices market. This guidance details what you need to do to place a medical device in the Great Britain, Northern Ireland and European Union (EU) markets. Manufacturers must adhere to specific requirements to place a medical device on the market in Great Britain, Northern Ireland, or the European Union.

Key Regulatory Considerations:

• Legislation: In Great Britain, devices must conform to the UK MDR 2002. Northern Ireland follows EU regulations due to the Northern Ireland Protocol.

• UKCA Marking: The UK Conformity Assessed (UKCA) marking is the new product marking for medical devices placed on the market in Great Britain. CE marking will continue to be recognized in Great Britain until 30 June 2023.

• Post-Market Surveillance: Manufacturers are required to have systems in place to monitor the performance of their devices once they are on the market and must report adverse incidents to the MHRA.

Guidance: Managing Expiring CE Certificates for IVDs

The European Union has extended the validity of certain certificates issued under Directive 98/79/EC on in vitro diagnostic devices (EU IVDD). This extension impacts the registration and management of these devices within the MHRA's Device Online Registration System (DORS).

Implications for Manufacturers:

• Extended Validity: Certificates that have been extended under the revised EU In Vitro Diagnostic Regulation (IVDR) transitional arrangements remain valid, subject to specific conditions.

• Registration Updates: Manufacturers relying on extended certificates must update their device registrations in DORS to reflect the extended validity.

• Compliance Assurance: It's imperative to ensure that devices continue to meet all applicable regulatory requirements during the extended validity period.

For the most current information and updates, always refer to the official MHRA guidance documents linked above.