The MHRA has released a draft policy concerning recognition of international regulators’ approvals of medical devices. The policy describes how the MHRA will be able to use the expertise and decision making of other regulatory partners for the ultimate benefit of patients. That being said, the MHRA will retain the authority to reject applications at their discretion. The list of countries that will be included in this policy, or comparable regulator countries, are shown below.
- Australia: Therapeutic Goods Administration (TGA)
- Canada: Health Canada
- European Union (EU): National competent authorities in the member states of the EU/ European Economic Area (EEA)
- United States of America (USA): Food and Drug Administration (FDA)
To make the devices eligible for this framework, they need to satisfy certain requirements, namely:
- Comply with the relevant legislation in a CRC
- 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 (for example, for substances which are carcinogenic, mutagenic or toxic to reproduction (CMR), of category 1A or 1B, or could result in sensitisation or an allergic reaction)
- 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 (UDI) 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 (PMS) requirements in the UK Medical Devices Regulations which are expected to come into force in 2024
More information can be found using the following link
