Overview of MHRA Guidance on Registration Dependent on Expiring CE Certificates: A Comprehensive Explanation
The Medicines and Healthcare products Regulatory Agency (MHRA) is the regulatory body responsible for ensuring the safety, quality, and efficacy of medicines and medical devices in the United Kingdom. In light of the UK’s departure from the European Union, the MHRA has issued guidance on the registration process for medical devices that are dependent on expiring CE certificates. This article aims to provide a comprehensive explanation of this guidance.
Before delving into the details of the MHRA guidance, it is essential to understand the context in which it was issued. With Brexit, the UK is no longer part of the European Union’s regulatory framework for medical devices. Previously, medical devices could be placed on the UK market if they had obtained a CE certificate, which demonstrated compliance with EU regulations. However, with the end of the transition period on December 31, 2020, the UK established its own regulatory system.
The MHRA guidance on registration dependent on expiring CE certificates outlines the steps that medical device manufacturers need to take to continue placing their products on the UK market. It applies to devices that have a valid CE certificate issued by an EU-recognized Notified Body and are currently registered with the MHRA.
1. Grace Period:
To facilitate a smooth transition, the MHRA has introduced a grace period for medical devices with expiring CE certificates. Devices that have a valid CE certificate can continue to be placed on the UK market until June 30, 2023, without requiring a UKCA (UK Conformity Assessed) mark.
2. Registration Process:
During the grace period, manufacturers must register their devices with the MHRA. The registration process involves creating an account on the MHRA’s Device Online Registration System (DORS) and providing relevant information about the device, including its intended purpose, risk classification, and details of the manufacturer.
3. UKCA Mark:
After the grace period ends on June 30, 2023, medical devices must bear the UKCA mark to be placed on the UK market. The UKCA mark indicates that the device meets the UK’s regulatory requirements. Manufacturers will need to obtain UKCA certification from a UK-approved Conformity Assessment Body (CAB) to affix the mark.
4. Transition from CE to UKCA:
To transition from a CE certificate to a UKCA certificate, manufacturers must engage with a UK-approved CAB. The CAB will assess the device’s conformity with the UK’s regulatory requirements, which are largely aligned with the EU’s regulations. The assessment may involve a review of technical documentation, testing, and quality management system audits.
5. Impact on Supply Chain:
The MHRA guidance also addresses the impact on the supply chain. It clarifies that devices placed on the Great Britain market (England, Scotland, and Wales) must comply with the new UK regulations, while devices placed on the Northern Ireland market must continue to meet EU regulations and bear the CE mark.
The MHRA guidance on registration dependent on expiring CE certificates provides a comprehensive explanation of the steps medical device manufacturers need to take to continue placing their products on the UK market. By following this guidance, manufacturers can ensure compliance with the UK’s regulatory requirements and maintain access to the UK market. It is crucial for manufacturers to familiarize themselves with this guidance and take appropriate actions within the specified timelines to avoid disruptions in their business operations.