UK Government Propose International Medical Device Recognition Framework

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:

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:

“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.”