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The regulation introduces the classification of IVD in the risk classes A, B, C, and D (§47). There are seven classification rules that are given in Annex VIII. MDCG guidance 2020-16 provides clarification of the classification rules and gives classification examples. Only devices in the lowest risk
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The provisions for the transition from IVDD to IVDR were changed by the EU commission with
Regulation (EU) 2022/112 and Regulation (EU) 2023/607. Due to certain issues and delays, some changes to the transition timelines were implemented for both MDR and IVDR. Notably, the "sell-off" provision of
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Regulation (EU) 2023/607 of the
European Parliament and of the Council of 15 March 2023 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical
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Regulation (EU) 2017/746 of the
European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (Text with EEA relevance.
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Regulation (EU) 2017/746 of the
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class, class A, are excluded from the requirement of notified body oversight.
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Medical Device
Regulations – Links You Should Be Aware Of
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