If you are currently selling, or planning to sell, medical devices in the United Kingdom, the clock is ticking for Class III, IIb, IIa, and I devices. As of January 1, 2022, the UK Medicines and Healthcare products Regulatory Agency (MHRA) has mandated that all devices and general IVDs from non-UK-based manufacturers or Authorized Representatives must be registered with the MHRA.
Changes that began going into effect on January 1, 2021 have and will continue to significantly alter the regulatory landscape for medical devices being sold into England, Scotland, Wales, and Northern Ireland. Those changes include the following registrations with the MHRA as of:
- May 1, 2021: active implantable medical devices, Class III medical devices, Class IIb implantable medical devices and IVD List A devices,
- September 1, 2021: Class IIb non-implantable medical devices, Class IIa medical devices, IVD List B devices, self-test IVD products, and
- January 1, 2022: Class I medical devices and general IVDs from manufacturers or Authorized Representatives not based in the UK.
The MHRA will continue to recognize European CE Marking as well as compliance to European Medical Device Directives, the Medical Devices Regulation (MDR), In-vitro Diagnostic Device Directive, and the In-vitro Diagnostic Medical Devices Regulation (IVDR) through June 2023. After that, manufacturers will need to obtain UK Conformity Assessed marks (UKCAs) to be legally marketed in England, Scotland, and Wales. Separate requirements regarding CE Marking as well as UKNI marking apply in Northern Ireland.
Boots on the ground: Assigning a Responsible Person in the UK
A fundamental component of the regulatory changes is the requirement for manufacturers based outside the UK to have a designated Responsible Person physically present in the United Kingdom. This rule does not apply to distributors and importers. Manufacturers based outside the UK are required to appoint a UK Responsible Person who is established in the UK. Requirements vary for appointing a UK Responsible Person to place devices on the Northern Ireland market.
The role of the Responsible Person is to essentially act on behalf of the non-UK-based manufacturers and carry out various medical device/IVD regulatory, quality, and compliance tasks that include registering the manufacturer’s devices with the MHRA before the devices can be placed on the Great Britain market. In addition, they are responsible for:
- Maintaining and providing all technical and regulatory compliance documentation for the appropriate authorities.
- Providing samples or access to devices/IVDs upon request by the MHRA.
- Informing the MHRA about any complaints or reports of suspected or actual incidents involving devices.
- Cooperating with the MHRA on preventive or corrective actions to reduce or mitigate device risk.
In addition to the regulatory revisions outlined above, the MHRA has proposed enhancing device traceability by establishing a unique device identifier (UDI) system, similar to the one described in the EU MDR/IVDR and in keeping with the International Medical Device Regulators Forum (IMDRF) guidance. This will require amending the UKMDR to mandate that economic operators share more information with the MHRA about the supply of medical devices/IVDs and their traceability.
The objective of the proposal is to improve the traceability of medical devices/IVDs being sold or in the supply chain in case regulatory measures, such as field safety corrective actions, are needed. In order to enhance transparency and to ensure effective post market surveillance activities, the MHRA has proposed bringing together all device-specific data into a single database. This database would include registration data, vigilance, post-market surveillance and market surveillance.
If you’d like to learn more about UK and EU regulatory changes, developing a regulatory strategy, and coming into compliance with new regulatory requirements in the UK/EU contact the regulatory and quality consulting specialists here at MEDIcept for information and assistance.
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MEDIcept is an international consulting firm offering a full portfolio of services to the medical device, IVD, and combination product industry. For over 25 years, our unique consulting practice and multidisciplinary team of former FDA, Notified Body, and industry experts have assisted hundreds of companies of all sizes with innovative, compliant, trusted, and cost-effective Regulatory, Quality, Clinical, and Engineering solutions.
For additional information, please contact Susan Reilly at SReilly@MEDIcept.com.