Dive Brief:
- The U.K. health regulatory agency has committed to working with its U.S. counterpart to improve and align medical device regulations.
- In a statement posted last week, the U.K. Medicines and Healthcare products Regulatory Agency said areas of interest include creating mutual recognition mechanisms and reducing duplication for manufacturers.
- The MHRA, which proposed recognizing U.S. device approvals in 2024, said it and the Food and Drug Administration will continue to perform technical work to assess alignment opportunities.
Dive Insight:
U.K. officials identified mutual recognition agreements as a way to support access to drugs and medical devices after cutting ties to the European Union as part of the Brexit process. Having previously given patients access to products authorized in the EU, the MHRA explored creating an expanded reliance mechanism to offer a fast track to companies with approvals from multiple peer regulatory agencies, including the FDA.
Prompted by the finalization of the U.S.-U.K. pharmaceutical partnership, the MHRA shared an update on its efforts to deepen cooperation with the FDA on medical devices. The goal is to give companies clearer, more predictable processes and accelerate patient access to new medical technologies.
As part of technical work with the FDA continuing over the coming months, the MHRA said that it will explore where future mutual recognition mechanisms may be appropriate. The MHRA said any new path to market will reflect the U.K.’s statutory requirements for safety, quality and effectiveness.
Last year, the U.K. government committed to implementing three international reliance routes that use authorizations issued in Australia, Canada, the EU and the U.S. By relying on device authorizations from its peers, the MHRA will allow the approved bodies that assess medical technologies in the U.K. to carry out truncated reviews tailored to each product’s risk classification.
Under a consultation that closes this week, the MHRA is considering indefinitely recognizing devices that comply with the EU medtech regulations. The proposal addresses a recurring request from an earlier consultation into U.K. medical device regulations.
International reliance is part of the MHRA’s broader cooperation efforts. In 2021, the agency published guiding principles for good machine learning practices with the FDA and Health Canada. The MHRA shared an update on its artificial intelligence work with the FDA last year.
