Decision Time for UK Medical Device Regulation: Diverge or Converge with the EU?

The MHRA appears to be considering an approach for UK regulations that would broadly mirror the EU model.

The start of 2024 brought updates and progress in both the EU and the UK on medical devices regulation. In January, the European Commission issued proposals to address implementation challenges faced by medical devices manufacturers, while a Medicines and Healthcare products Regulatory Agency (MHRA) roadmap outlined UK reforms to deliver greater cooperation with overseas regulators and likely recognition of medical devices that are compliant with EU rules.

This course delves into the reform package, which broadened the definition of medical devices, included cosmetic contact lenses, and introduced stringent conformity assessments and risk classifications.

By the end of this course, you should be able to:

1. Understand the historical context and the reasons behind the introduction of the EU Medical Device Regulation (MDR) in 2016
2. Describe the key components of the MDR including the expanded definition of medical devices and the inclusion of previously unregulated products
3. Explain the enhanced conformity assessment procedures and risk-based classification system for medical devices under the new regulations