The European Commission’s Medical Devices Coordination Group (MDCG) has issued a guidance document outlining the role of the Notified Body’s clinical evaluation assessment report (CEAR) in assessing a device under… Read More
The European Commission has updated its Q&A document on conformity assessment procedures for protective equipment like face masks, gloves, coveralls, etc. The corresponding document can be downloaded here. Furthermore, the… Read More
Back in April, 2020, the European Commission has committed itself to set up a database of CE marked COVID-19 IVD tests. The Commission has now published a link under which… Read More
