During last 5 May preliminary hearing, the Council of Ministers approved the draft of the Legislative Decree adjusting the national …
Continue reading “ITALY: approved draft of the national decree adjusting to MDR/IVDR”
MDCG 2022-6 guidance on Significant Changes to Legacy IVD Devices pursuant to Article 110(3) IVDR was published a few weeks …
Continue reading “EUROPE: guidance MDCG 2022-6 and Significant Changes in Period Of Grace”
Last month, the Medical Device Coordination Group (MDCG) published two important guidelines. MDCG 2022-3 “Verification of manufactured class D IVDs …
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The Medical Device Coordination Group published the new guidance MDCG 2022-2 “Guidance on general principles of clinical evidence for In …
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In the first week of January 2022, Commission Implementing Decision (EU) 2022/6 concerning new harmonised standards MDR (EU) 2017/745, and …
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UPDATE OF 25 JANUARY 2022 OFFICIAL! PUBLISHED IN THE OFFICIAL JOURNAL OF THE EUROPEAN UNION REGULATION (EU) 2022/112 AMENDING REGULATION IVDR …
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In October 2021, the Medical Device Coordination Group (MDCG) published the “Joint implementation and preparedness Plan for Regulation on in …
UPDATE OF 25 JANUARY 2022 OFFICIAL PROGRESSIVE ROLL-OUT OF REGULATION IVDR (EU) 2017/746 FOR CERTAIN IVD DEVICES.REGULATION (EU) 2022/112 OF THE …
Continue reading “EUROPE: a proposal to extend the IVDR (EU) 2017/746 Regulation”
IVDR Emergency Kit: the fastest solution to respond to the main obligations of the IVDR (EU) 2017/746. Experts Thema projected a …
The most commonly used acronyms in the field of Medical Devices and In Vitro Diagnostic Medical Devices (IVD) (in alphabetical …