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News
26 May
IVDR D-Day!
25 May
MDCG issues guidance on clinical trials for medicinal products and in vitro diagnostic medical devices (IVDR)
20 May
MDCG issues guidance on the application of IVDR to legacy and other devices on the market prior to 26 May 2022 |
20 May
Today is Clinical Trials Day |
04 May
MDCG issues guidance on significant changes in design and intended purpose under IVDR |
01 Apr
Directorate for Health and Food Safety issues joint implementation plan for the IVDR |
24 Mar
MDCG issues updated guidance concerning Safety and Performance summary
31 Jan
Clinical Trials Regulation for pharmaceutical studies (536/2014) applicable
13 Jan
MHRA updates guidance on clinical investigations for medical devices |
03 Jan
Read the latest blogpost of our CEO on the IVDR amendment |
02 Jan
MDCG issues updated guidance on COVID-SARS-2 IVD performance evaluation
01 Jan
MDCG issues guidance on clinical evidence for IVDs
28 Dec
THE SHOCKING DATA ON COVID SELF-TESTS |
20 Dec
EU adopts progressive roll-out of IVDR |
10 Dec
FDA issues draft guidance on Real World Evidence |
09 Dec
MDCG issues guidance on substantial modification of clinical investigation under MDR |
14 Oct
EU proposes IVDR delay due to COVID-19 and notified body shortage |
04 Oct
EU IVD expert panel accepts submissions for Performance Evaluation Consultation Procedures |
