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UK Government Propose International Medical Device Recognition Framework
In a statement of policy intent, UK’s MHRA discusses how it would recognize regulatory approvals from Australia, Canada, EU, and US depending on device type, class, and prior approval.
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Today, the United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA), an executive agency of the Department of Health and Social Care, announced a proposed framework for the international recognition of medical devices in order to protect public health while also ensuring access to medtech innovation.
Currently a draft, the statement of policy intent discusses how the UK government intends to recognize regulatory approvals from Australia, Canada, the European Union, and the United States depending on device type, class, and prior approval. Additionally, it is in talks with the Pharmaceuticals and Medical Devices Agency (PMDA) to also recognize device approvals from Japan.
The draft, according to MHRA, focuses on reducing the duplication of medical device assessments by comparable regulators so that resources can be targeted on “innovative products for the benefit of patient health,” according to a GOV.UK statement.
Manufacturers would have to meet specific requirements to be eligible for the proposed framework, including:
Must comply with comparable regulator countries (CRC) relevant legislation.
Have English language labeling and packaging.
Comply with Great Britain requirements for electronics compatibility, units of measurements, and labeling materials of concern where applicable.
Have all aspects of the device be in line with the device that is currently authorized in the CRC, including design, manufacturing process, and intended purpose.
Have a UK responsible person, the name and address of which will be included on the label.
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 new post-market surveillance (PMS) requirements in the UK Medical Devices Regulations with are expected to come into force this year.
Of note, the proposed framework would provide a manufacturer with a certificate of international recognition, granting device access to the Great Britain market. However, it would not provide a UKCA marking or UKCA certification.
The following devices would be excluded from international recognition:
Exempted in-house devices
Custom-made devices
Software as a Medical Device (SaMD) – including Artificial Intelligence as a Medical Device (AIaMD) products that do not satisfy UK intended purpose guidelines.
SaMD (including AIaMD) products approved via a route which relies on equivalence to a predicate. An example of which would be the US 510(k).
Products granted market access in the CRC via a recognition route.
Class IIb
Companion diagnostics approved via a route which relies on equivalence to a predicate.
Companion diagnostics and combination products containing medicinal substances that are not licensed in the UK.
Products excluded from the scope of UK MDR 2002.
“Today’s announcement is an important step forward towards a robust medtech regulatory framework that prioritizes patient safety, gives patients access to the medical devices they need and ensures the UK remains an attractive market for medical technology innovators,” said Dr. Laura Squire, chief quality and access officer of the MHRA, in a statement. “We will continue to work on how our intended policy on international recognition of medical devices will operate in practice. By sharing the draft policy now, we aim to give greater clarity about the MHRA’s future direction of making regulatory approvals simpler, where it is safe to do so. At the same time, we remain fully committed to the UKCA marking for medical devices.”
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