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Manual on BorderlineManual on borderline and classification under Regulations (EU) 2017/745 and 2017/746 v5 Background note on the use of the Manual on borderline and classification for medical devices under the Directives.April 2026⌄
Manual on borderline and classification under Regulations (EU) 2017/745 and 2017/746 v5PDF · Unverified extraction previewOfficial source
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MDCG 2024-13Regulatory status of ethylene oxide (EtO) intended for the sterilisation of medical devicesOctober 2024⌄
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MDCG 2022-5 rev.1Guidance on borderline between medical devices and medicinal products under Regulation (EU) 2017/745 on medical devicesOctober 2024⌄
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MDCG 2021-24 rev.1Guidance on classification of medical devicesApril 2026⌄
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Helsinki ProcedureHelsinki Procedure for borderline and classification under MDR & IVDRSeptember 2021⌄
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MDCG 2020-16 rev.4Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746March 2025⌄
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MDCG 2019-11 rev.1Qualification and classification of software - Regulation (EU) 2017/745 and Regulation (EU) 2017/746June 2025⌄
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