Unconstrained by having to compromise with other countries’ regulatory approaches, the UK is now seeking views on its proposal for a pioneering and “bold new regulatory regime” for medtech products.
The Medicines and Healthcare products Regulatory Agency has published its consultation document on the future regulation of medical devices and IVDs in the UK. Comments on the document will be accepted until 25 November 2021.
The new regime is scheduled to be in force at the beginning of July 2023, the date from which CE-marked medical devices will no longer be accepted in Great Britain,...
Guardant Health introduces a new germline panel test to help guide cancer treatment, assess the risk of secondary cancers in patients and identify family members at risk of cancer.
A study from Babson Diagnostics published in the peer-reviewed Journal of Applied Laboratory Medicine showed that capillary blood sample volume issues can overcome historical challenges, such as poor quality, through a technique called assay miniaturization.
The UK has issued clearer guidance to help drug and medical device sponsors demonstrate how they intend to include a diverse and relevant range of participants in their clinical trials.
