Moving to partially allay uncertainty regarding the approval of medical devices for use in their country, the government of the United Kingdom has reportedly passed regulations applicable to medical devices intended for sale there.
According to a late-February posting on the website of Medical Design & Outsourcing, the UK’s Medicines and Medical Devices Act of 2021 was passed to address the regulatory gap for medical devices created when the UK officially left the European Union (EU) in January 2021. Until then, medical devices were required to meet EU regulatory requirements, including the EU’s Medical Device Regulation (MDR).
The new law reportedly sets regulations regarding device safety, performance, and record-keeping requirements, including an increased focus on patient safety. It also sets out potential legal consequences for failing to comply with the law’s requirements.