EU issues guidance on medical device clinical trials |
MDCG publishes tool to decide whether your software is a medical device.
MDCG issues guidance on state of the art of COVID-19 tests
Today is International Women’s Day: Do you know women are still underrepresented in Clinical Trials?
Proud to say, that today ACS passed a client audit with no findings!
EU commission issues Q&A on COVID-19 tests conformity assessment and performance |
EU updates guidance on conduct of clinical trials during COVID-19: more room for remote SDV |
Conditional approval for 3rd vaccine against COVID-19 |
EU Commission allows for remote medical device audits during COVID-19 pandemic |
CBG Chair column explaining difference in COVID-19 vaccine approval speed |
RAPS issues article on Brexit deal and impact Medical Device industry |
Happy and Healthy New Year! The year of truth for Medical Devices |
New IMDD template in line with MDR |
Risk inventory for conduct of clinical research |
First Croatian NB designated under MDR, 18th overall |
New procedure for submitting local feasibility declaration |
Updated meeting schedule of MDCG and subgroups |
EUDAMED Clinical Investigations and performance studies module still pending |
Leidraad voor METC’s over onderzoek met medische hulpmiddelen |
English Subject Information Sheet for adults now available |
CCMO competent authority for clinical investigations with medical devices |
CCMO issues revised model for Informed Consent (Dutch)|
Conditions for (re)starting clinical research in healthcare institutions and CRUs aligned |
Read the latest CEO blog: MDR/ IVDR Clinical Evaluation toolkit part II |