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News
15 Jul
Draft version of new ISO 14155 published for voting |
10 Jul
EU Commission issues updated timeline for EUDAMED |
25 Jun
MDCG issues guidance on clinical evaluations for orphan devices |
17 Apr
MDCG issues guidance on the investigator’s brochure |
15 Apr
MDCG issues guidance on safety reporting in performance studies under IVDR |
12 Apr
New version of ISO14155 enters enquiry phase with ISO members |
12 Mar
MDCG issues guidance on content and synopsis of the Clinical Investigation Plan for Medical Device studies |
21 Feb
EU Council endorses key updates to the IVDR |
23 Jan
EU Commission proposes IVDR deadline extension |
21 Dec
MDCG issues guidance on exemptions from clinical investigations for class III and implantable devices |
18 Oct
MDCG issues guidance on Medical Device Software (MDSW) – Hardware combinations |