There had been handful of warning signals against well-known notified bodies designated against the MDR. Why were they there and why have they just been removed?
Until earlier this week, there had been a series of warning signs on the European Commission’s Nando website that seemed to undermine the designation notices for a handful of notified bodies that are listed against the EU’s Medical Device Regulation.
These have just been removed because they wrongly suggested a problem with using those affected notified bodies to demonstrate certification under the MDR when there is none.
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.
