Warnings about lack of notified body capacity to certify products against the EU’s new medtech regulations have become likes waves repeatedly crashing on the shore. With 19 months to go until the absolute deadline for MDR compliance, the latest figures appear alarming.
In total, 1,990 conformity assessment certificates have been granted to date under the EU’s Medical Device Regulation, according to just published official EU figures.
In all, 8,120 applications had been made to notified bodies for the assessment of products under the Medical Device Regulation since the beginning.
But this is just the tip of the iceberg.
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.
