Updates to MDCG 2022-4
On 27 May 2024, The Medical Device Coordination Group (MDCG) has released an update to the MDCG 2022-4 (Rev.2) guidance document.
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Survey: Regulatory governance and innovation in the field of medical devices and in vitro diagnostic medical devices
Dear Market Operators There is an important survey on the sectorial regulatory governance and innovation in the field of Medical Devices (MDR) and In Vitro Diagnostic Medical Devices (IVDR), conducted by The…
Read articleGuidance – MDCG endorsed documents
The European Commission Health and Food Safety DG SANTE has just released two Guidance documents for both Manufacturers and Notified Bodies in the realm of Medical Devices (MDR) and In Vitro Diagnostic Medical Devices (IVDR): 𝗠𝗗𝗖𝗚 𝟮𝟬𝟮𝟯-𝟱: 𝗚𝘂𝗶𝗱𝗮𝗻𝗰𝗲…
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NoBoCap MDR Masters Level Module and Post-Program Evaluation
The NoBoCap project, recently completed the first cohort of its ambitious MDR (Medical Device Regulation) master’s Level Module 1 “Implementing Regulatory Requirements for Medical Devices” led by SGS (NB 1639) and TU Dublin.
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