Skip to main content
Premium Trial:

Request an Annual Quote

UK Opens Consultation on New Diagnostics Regulations

NEW YORK – The UK Medicines and Healthcare Products Regulatory Agency on Thursday opened a public consultation regarding new regulations governing medical devices and in vitro diagnostics.

The UK government said it intends to develop a new regime for IVDs that improves safety and is transparent and responsive, and is reaching out to medical device and test developers, patients, clinicians, and healthcare professionals for assistance in creating that regime. Part of the outreach involves a questionnaire that will be available online until Nov. 25. 

MHRA is taking these measures to lock into place the UK's regulatory approach following the country's exit from the EU, which was finalized last year. In addition to launching the questionnaire, MHRA also published a cache of documents related to the consultation, covering the legal framework for developing the new regulations, as well as a point-by-point overview of proposed regulations with questions for participants to weigh in on.

As noted in an executive summary, the UK is updating its regulatory regime under the powers in the Medicines and Medical Devices Act, passed this year, which allows the government to amend the 2002 Medical Devices Regulations, which have governed medical devices in the UK.

Amendments to create the new framework should be in place by July 2023, by which time the UK will transition to a new system where government-sanctioned organizations, called approved bodies, will assess medical devices and IVDs for compliance with UK regulations. Should submissions be cleared for use, they will receive a UKCA mark, similar to a US Food and Drug Administration 510(k) clearance in the US or a CE-IVD mark in the EU. 

Sajid Javid, secretary of state for health and social care, said in a statement that the consultation comes at a "fitting moment" for the UK.

"When it comes to the safety of the medical devices we use, we can and must do better," Javid said. "Our departure from the European Union has provided us with a newfound regulatory freedom and a unique chance to reshape our rules," he added.

Javid noted that the response of the UK's medical devices and IVD sector to the ongoing COVID-19 pandemic has led to advances in how IVDs are used and added that "enormous leaps in software and artificial intelligence" also created a need to improve patient safety. Javid said the ongoing consultation will provide a platform from which the UK can support a life sciences sector that "continues to lead the world and safeguard and advance the health of our nation."