Medical Device Regulations – UK
UK Responsible Person - MHRA
The requirements outlined in the UK Medical Devices Regulations, including the UK Conformity Assessed (UKCA) mark, now regulate the placing of medical devices in the UK market.
This means that overseas manufacturers (those without a registered UK-based office) are required to appoint a UK Responsible Person and detail them as part of their organisation.
The UK Responsible Person acts as the essential interface between manufacturers and the Medicines and Healthcare products Regulatory Agency (MHRA), assuming legal responsibility for device compliance, registration, and post-market surveillance.
The UK Responsible Person must have the necessary regulatory or medical device knowledge to perform this function, and Cranage Veritas will assist you with this requirement.
Our Responsibilities as the UK Responsible Person:
- Allocating the most suitable experienced engineer suited for your product.
- Ensuring appropriate conformity assessment procedures have been carried out for the medical devices.
- Maintaining technical documentation and declarations of conformity.
- Ensuring device labelling and instructions for use comply with UK regulations.
- Registering devices with the MHRA and ensuring all information remains up to date.
- Facilitating communication and cooperation with the regulatory authorities.
- Responding to requests from the MHRA for device samples and documentation.
- Undertake post-market surveillance and report adverse incidents to the MHRA.
Our Experts
Our consultancy services for the UK Responsible Person function are invaluable in navigating the complexity of regulations, and we possess the necessary regulatory knowledge and experience to liaise with various regulatory authorities.
Our consultants:
- Possess in-depth knowledge of current UK medical device legislation, including MHRA guidelines, UKCA / CE marking.
- Prepare and maintain the technical files, conformity declarations, and regulatory registration documents.
- Offer assistance with device registration with MHRA.
- Guide on reporting adverse events and maintaining dialogue with regulators.
- Conduct bespoke training within your internal departments to ensure continued compliance, awareness, and readiness for regulatory changes.
Cranage Veritas - The Only Consultancy Partner You Will Need
Having a Responsible Person to represent your medical organisation is a regulatory requirement.
We have extensive experience with regulatory directives and standards, including the collateral requirements that must also be met, as well as the requirements of the UKCA/CE marking.
Additionally, our technical experts possess extensive experience in the medical regulatory industry, with in-depth knowledge of the standards that form the framework of this complex sector.
We understand the requirements of the MHRA and, with a proactive approach, can offer quick responses and solutions to the MHRA's requests.
Our services can be customised to address specific device types, company sizes, and market entry strategies, ensuring you only receive the essential services you require.
Having a Responsible Person within your medical organisation is a regulatory necessity, but choosing the right consultancy partnership is not just a regulatory necessity - it is a catalyst for sustainable growth and robust market presence.
