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UK – MHRA drafts mRNA cancer immunotherapy guidance
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) is seeking input on its draft guidance for developing individualized messenger ribonucleic acid (mRNA) cancer...
International – IMDRF finalizes good machine learning practice, software risk documents
The International Medical Device Regulators Forum (IMDRF) on Wednesday finalized two highly anticipated technical documents detailing guiding principles for good machine learning practices (GMLP)...
Europe – MDCG 2022-3 rev.1 – Verification of manufactured class D...
Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) establishes
the requirements for notified bodies involved in the conformity assessment of applicable classes of...
France – La HAS dévoile son projet stratégique 2025-2030
Vieillissement de la population, inégalités sociales, disparités territoriales, soutenabilité financière, enjeux environnementaux ou encore accélération de l’innovation en santé : les défis qui se...