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EC published final report of Study on implementation of Article 17 of MDR on medical devices on the EU market,
in Uncategorized
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MDCG publishes 2024-03 on Guidance on contents CIP,
in Uncategorized
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IMDRF publishes guiding principles to support medical device health equity,
in Uncategorized
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EC proposes to extend transition periods for certain IVDs, gradual roll-out of Eudamed and an information obligation in case of interruption of supply,
in Uncategorized
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MDCG 2023-7 on Exemptions MDR Clinical Investigation published,
in Uncategorized
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MDCG 2021-27 Revision 1 published,
in Uncategorized
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MDCG 2019-7 Rev.1 published on the PRRC,
in Uncategorized
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MDCG 2023-5 and MDCG-6 guidances published on Annex XVI products,
in Uncategorized
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MDCG 2021-6 MDR – Questions & Answers regarding clinical investigation – Rev.1,
in Uncategorized
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2023/2713: Regulation on designating European Union reference laboratories in the field of in vitro diagnostic medical devices,
in Uncategorized
