Dive Brief:
- The U.K. medtech regulator shared a roadmap of the documents it will publish to create a new framework for the sector over the next two years.
- In the roadmap, the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) sets out plans to talk to the medtech industry about its approach to unique device identification, quality management systems (QMS), implants and more.
- The MHRA plans to have the “core elements” of the new framework for medical devices in place by the next year. The regulations are intended to support more international harmonization.
Dive Insight:
Delays to the European Union’s new device regulations meant that framework never became part of U.K. law. As such, the U.K. left the EU with device regulations that dated back to 2002 and the freedom to set its own rules for the industry going forward. The government established a transitional period that runs to 2028 or 2030, depending on the device, to avoid supply disruption while it moves to the new framework.
The first item on the roadmap for 2024 and 2025 is a discussion about international recognition. The MHRA began talking to industry participants last year and has received some positive feedback. Peter Ellingworth, chief executive of the Association of British HealthTech Industries, said in a statement that “international recognition will ensure that U.K. patients maintain access to safe and effective health tech, that is both life-enhancing, and life-saving.”
The MHRA said the international recognition framework will enable “swifter access” to devices that are already approved by “comparable regulators” or have Medical Device Single Audit Program certificates. The outline of the framework is in line with MHRA’s international recognition procedure for medicines, which offers shorter reviews of drugs approved in seven countries and regions including the U.S. and EU.
Over the rest of 2024, MHRA plans to hold talks about topics such as scope and classification, essential requirements, approved bodies, clinical investigations, QMS and conformity assessments. The MHRA shared more details in another document, explaining that it plans to change the classification of several types of devices and bring essential requirements into closer alignment with the EU rules.
Implantable medical devices are an area of focus. MHRA plans to classify implants as part of changes that “will result in more stringent pre and post market requirements and requiring manufacturers to provide implant cards to enable patients to know which device they have had implanted.” Implants have been a focus for the government since a report it commissioned found fault with oversight of the devices in 2020.
