Updated Guidance for UK Virtual Manufacturers of Medical Devices: Compliance Requirements

Virtual manufacturers of medical devices that do not need UK Approved Body/EU Notified Body approval are still required to hold the full technical documentation for their medical devices, which may be examined by the MHRA (full legal text: Virtual manufacturing of medical devices – GOV.UK (www.gov.uk)).

The UK government has issued updated guidance on regulatory changes affecting virtual manufacturers of medical devices in Great Britain and Northern Ireland. These changes follow the end of the transition period with the EU. The guidance introduces new product markings, namely the UKCA mark and the CE UKNI marking, for relevant goods, including medical devices. Virtual manufacturers now have specific responsibilities and requirements to comply with.

A summary of the key updates and requirements for virtual manufacturers in the UK medical device market.

Extension of CE Mark Acceptance:

CE marked medical devices will continue to be accepted in Great Britain until the applicable deadline, with the latest deadline set for June 30, 2030. Separate rules apply in Northern Ireland.

Introduction of UKCA and CE UKNI markings:

Certain medical devices placed on the UK market must bear the UKCA mark for Great Britain or the CE UKNI marking for Northern Ireland, depending on the applicable conformity assessment conducted by a UK Notified Body.

Definition and responsibilities of virtual manufacturers:

Virtual manufacturers are organizations that source products from another company (OEM) and assume the legal responsibilities of the manufacturer. The regulatory requirements remain the same for virtual manufacturers.

Responsibilities and documentation:

Virtual manufacturers must have audited quality management systems and maintain full technical documentation for their medical devices. Registration with the Medicines and Healthcare products Regulatory Agency (MHRA) is required, along with compliance with revised requirements and signing a Declaration of Conformity.

Technical documentation requirements:

Virtual manufacturers must possess comprehensive technical documentation integrated into their quality management systems, including relevant data such as labels, instructions for use, and risk assessments. Redacted proprietary information may be accepted if it does not hinder the assessment process.

Contractual agreements:

Virtual manufacturers should establish contractual agreements with OEMs, covering aspects such as product design, post-market surveillance, post-production follow-up, notification of changes, unannounced audits, and the prohibition of multiple virtual manufacturers for the same device.

Handling OEM certification issues:

Virtual manufacturers should obtain evidence of OEM certification suspension/withdrawal, assess its impact, and consider using critical suppliers to ensure product supply. Prompt notification to the MHRA is required in case of OEM certification loss.

Dispute resolution:

In case of disputes with UK Approved Bodies/EU Notified Bodies, virtual manufacturers can seek clarification from the MHRA.

Transition to importer/distributor status:

This includes translation of information, packaging changes, brand affixing, and clear identification on labeling and packaging. Virtual manufacturers must adhere to the updated guidance, including compliance with new markings, fulfilling responsibilities, and maintaining proper documentation. By understanding and following these requirements, virtual manufacturers can navigate the changing regulatory landscape and continue providing safe and compliant medical devices in the UK. For detailed guidance, virtual manufacturers should refer to the complete documentation provided by the MHRA.