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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On 15th December 2021, the Council of the European Union, and the European Parliament adopted the proposal of the progressive …
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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 20 DECEMBER 2021 UPDATE IVDR (EU) 2017/746. Progressive roll-out of the In Vitro Diagnostic Medical Devices Regulation! The …
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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 …
In June 2021 the Medical Device Coordination Group (MDCG) published on the website of the European Commission the IVDR Preparation …
In July 2021, the first MDR and IVDR harmonised standards were published in the Official Journal of the European Union. …
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The ISO 20916:2019 standard “In vitro diagnostic medical devices – Clinical performance studies using specimens from human subjects – Good …
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The White Paper “Factsheet for Manufacturers of in vitro Diagnostic Medical Devices” explores the in vitro Diagnostic Medical Devices Regulation …