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CIOMS Glossary of ICH Terms and Definitions. Version 10
The CIOMS has released Version 10 of its Glossary of ICH Terms and Definitions, bringing together terminology from current International Council for Harmonisation (ICH) guidelines and Q&A documents. The glossary serves as a centralised reference for professionals...
Guidance on standardisation for medical devices Appendix: Transition to the ‘EU REP’ symbol in EN ISO 15223-1
The European Commission has published a new appendix to MDCG 2021-5 Rev. 1 – Guidance on standardisation for medical devices: 📄 Appendix: Transition to the “EU REP” symbol in EN ISO 15223-1 📅 Published: June 2026 This follows the publication in the...
MDCG Position Paper: Management of SS(C)P in EUDAMED after mandatory use
The Medical Device Coordination Group (MDCG) has published MDCG 2026-4: Management of SS(C)P in EUDAMED after Mandatory Use, providing guidance on how Summary of Safety and Clinical Performance (SSCP) and Summary of Safety and Performance (SSP) documents will be...
Commission Implementing Decision amending Implementing Decision (EU) 2021/1195 as regards the harmonised standard for symbols to be used with information to be supplied by the manufacturer
📢 Regulatory Update: Commission Implementing Decision (EU) 2026/1313 On 15 June 2026, the European Commission adopted Commission Implementing Decision (EU) 2026/1313, amending Implementing Decision (EU) 2021/1195 regarding the harmonised standard for symbols...
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