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All documents related to the MDR and IVDR amending Regulations,
in Uncategorized
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Manufacturer’s Declaration in relation to Regulation (EU) 2024/1860,
in Uncategorized
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MDCG 2021-5 Guidance on standardisation for medical devices – Rev.1 published,
in Uncategorized
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MDCG 2024-10 Clinical evaluation of orphan medical devices published,
in Uncategorized
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MDCG 2022-13 Designation, re-assessment and notification of conformity assessment bodies and notified bodies – Revision 1,
in Uncategorized
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MDCG issues 1 template and 5 guidances on device specific vigilance,
in Uncategorized
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MDCG revised guidance 2022-4,
in Uncategorized
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MDCG 2024-5 Published on Guidance on the Investigator’s Brochure (MDR),
in Uncategorized
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MDCG 2022-9 Rev.1 Summary of safety and performance Template published,
in Uncategorized
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MDCG 2024-4 published on Safety reporting in performance studies of in vitro diagnostic medical devices under the IVDR,
in Uncategorized
