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Revised MDCG Guidance documents released

Revised MDCG Guidance documents released

On September 25, 2024, the Medical Device Coordination Group (MDCG) released Revision 1 of the guidance on the application of transitional provisions for the certification of Class D in vitro diagnostic medical devices under Regulation (EU) 2017/746 (MDCG 2021-4). This

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New MDCG Guidance documents released!

New MDCG Guidance documents released

On July 8th, 2024, the Medical Device Coordination Group (MDCG) released its third revision on the guidance for classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746 (MDCG 2020-16 Revision 3). The updates include a new definition

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Amending Regulation (EU) 2024/1860 was published!

Amending Regulation (EU) 2024/1860 was published

On July 9th, 2024, the European Commission published in the Official Journal of the European Commission (OJEU) Regulation (EU) 2024/1860 amending regulations (EU) 2017/745 or the Medical Device Regulation (MDR) and Regulation (EU) 2017/746 or the in vitro diagnostic medical

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EU Parliament Approves Proposal

On April 25th, 2024, the European Parliament approved the proposal made in January 2024 by the European Commission for a Regulation amending Regulations 2017/745 MDR, and 2017/746 IVDR as regards a gradual roll-out of Eudamed, information obligation in case of

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