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Application of MDR Article 97,
in Uncategorized
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Manufacturer’s Declaration in relation to Regulation (EU) 2023/607,
in Uncategorized
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MDCG revised guidance 2020-3,
in Uncategorized
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Commission guidance on the content and structure of the summary of the clinical investigation report,
in Uncategorized
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MDCG 2023-1 Guidance on the health institution exemption under Article 5(5) of the MDR and IVDR,
in Uncategorized
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MDCG published 2023-2: List of standard fees (NB),
in Uncategorized
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January 6, 2023: Press release of European Commission: Public health: more time to certify medical devices to mitigate risks of shortages,
in Uncategorized
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MDCG published guidance on the PSUR under the MDR,
in Uncategorized
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MDCG published guidance concerning a substantial modification of a performance study under the IVDR,
in Uncategorized
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MDCG published guidance regarding documents to be provided when an IVDR performance study is to be conducted,
in Uncategorized
