On May 21, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) proposed allowing medical devices to enter the UK market, provided they are authorized in “comparable regulatory countries” (CRC), starting with the regulatory bodies of Australia, Canada, the EU, and the US, with Japan to be considered next. This draft is expected to take effect in 2025.
“Simplifying approvals while ensuring safety”
Chief Quality and Access Officer Laura Squire stated that this plan is an important step toward developing a regulatory framework for medical technology that prioritizes patient access and safety and ensures that the UK remains attractive to medical technology manufacturers.
“We will continue to study how the anticipated policies on international recognition of medical devices will be implemented in practice,” Squire said in a statement. “By sharing the draft policy now, we aim to clarify the future direction of the MHRA, which is to simplify regulatory approvals while ensuring safety.
“Meanwhile, we remain fully committed to the UK’s conformity assessment (UKCA) marking for medical devices,” she added. “We will continue to strengthen the capabilities of UK approval bodies and work to ensure that the UKCA mark supports the earliest possible market entry for the most innovative and transformative safe medical products.”
Since Brexit, the UK government has recognized that it lacks the resources to review market-entry medical devices compared to other CRCs, potentially causing regulatory delays. Therefore, last year, Chancellor Jeremy Hunt stated that if certain products are already approved in specific jurisdictions, the MHRA would use a “fast, typically near-automatic sign-off” system to allow these products to enter the UK market.
“The proposed framework will provide international recognition certificates that allow devices to enter the UK market but will not offer the UKCA mark or UKCA certification,” the MHRA stated. “Market access for eligible devices will be based on the validity of the certificates provided by the CRC and must be re-certified upon the expiration of their original certificates.”
Expected Regulatory Approach
Under the proposed access pathway, to qualify for the proposed framework, products need to:
- Comply with relevant regulations of the comparable regulatory country (CRC)
- Have English labels and packaging
- Meet UK requirements for electronic product compatibility (frequency, voltage, and plug type), measurement units, and labeling for applicable materials (e.g., substances classified as 1A or 1B carcinogenic, mutagenic, or toxic to reproduction (CMR), or substances that may cause allergies or hypersensitivity reactions).
- Ensure all aspects of the device (including design, manufacturing process, and intended use) are consistent with the device currently approved for use in the CRC
- Have a UK Responsible Person, whose name and address will be included on the label
- Mark parts and labels with UDI as required by the UK Medical Devices Regulations or the CRC
- Comply with the new post-market surveillance (PMS) requirements in the UK Medical Devices Regulations, expected to take effect in 2024
- The proposed framework will provide international recognition certificates that will allow devices to enter the UK market but will not provide the UKCA mark or UKCA certification.
- Market access for eligible devices will comply with the validity of the certificates provided by the CRC and must be re-certified upon the expiration of their original certificates (if applicable).
- In cases where indefinite market access is allowed by the CRC (e.g., in the US), the validity of the international recognition certificate will align with the quality management system (e.g., MDSAP certificate).
The proposed plan also lists types of devices that are not eligible, such as software as a medical device (SaMD) using comparative pathways (e.g., US 510(k)), Class IIb implants, and Class III medical devices.
The agency added that eligible Northern Ireland goods (U Exit) will continue to be allowed to enter the UK market indefinitely under a valid CE mark.
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