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