The MHRA recently released the following policy statement setting out a framework to allow devices with comparable regulator country (CRC) approvals access to the UK market depending on device type, class, and prior approval:
This welcome statement is an important step towards a smarter form of regulatory oversight for medical devices in Great Britain which reduces the duplication of assessments by comparable regulators. The statement proposes an international recognition pathway for access to the UK market to be in place alongside the implementation of future core UK medical device regulations which are aiming to be in force in 2025.
The proposed framework is yet to be finalised, but manufacturers should take account of the statement to start considering whether their devices will be eligible for the proposed alternative routes to market.
Under the framework, manufacturers with eligible devices will be able to apply for a certificate of international recognition that will grant devices approved in Canada, the US, Europe and Australia access to the Great Britain market but would not provide a UKCA marking or UKCA certification. Manufacturers of medical devices would still have the option to use the UKCA marking to place devices on the Great Britain market.
Software as a Medical Device (SaMD) (including Artificial Intelligence as a Medical Device (AIaMD) approved via a route which relies on equivalence to a predicate (US 510(k)) will not be eligible for this international recognition, but de novo or pre-market US-approved software as a medical device could take advantage of the proposed framework for UK market access.
To be eligible, products with approval from a comparable regulator country would need to:
- have English language labelling and packaging
- comply with Great Britain requirements for electronics compatibility (frequency, voltage and plug type), units of measurement, and labelling materials of concern where applicable
- have all aspects of the device be in line with the device that is currently authorised in the CRC, including the design, manufacturing process and intended purpose
- have a UK responsible person, the name and address of which will be included on the label (this may be via over-labelling, and MHRA will also investigate the ability for digital labelling or digital label solutions)
- have a physical unique device identifier on parts and labels in compliance with the requirements in the UK Medical Devices Regulations or the CRC
- comply with the new post-market surveillance requirements in the UK Medical Devices Regulations which are expected to come into force in 2024
Market access for eligible devices would likely be in accordance with the validity of the supplied certificate from the CRC and must be re-certified when their original certificate, if applicable, expires, or if indefinite market access is granted by a comparable regulating country, the validity for the certificate of international recognition would be in accordance with the quality management system certificate
Manufacturers will need to submit a dossier to the MHRA in the IMDRF ‘table of contents’ format, or equivalent format used in the CRC prior to and for AIaMD there will be a review of premarket (training and test) data, implementation verification and validation and use of predetermined change control plans.
At Deviceology, we think this is a completely positive step in the right direction. This approach will remove unnecessary regulatory hurdles and cost-facing manufacturers operating across multiple markets, and will hopefully encourage better patient outcomes by enabling faster market access for proven and safe innovations. We’ll continue to track these developments as they emerge, but for now, well done MHRA. We look forward to helping manufacturers with pragmatic and safe approaches to market.
