EU
- Annex VIII of Regulation (EU) 2017/745
- Borderline classification - medical devices/pharma - nose spray
- Commission Implementing Regulation (EU) 2022/2347 of 1 December 2022 laying down rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council as regards reclassification of groups of certain active products without an intended medical purpose
- Manual on Borderline and Classification in the Community Regulatory Framework for Medical Devices
- 2021–24 Guidance on classification of medical devices (MDCG)
- 2022-5 – Guidance on borderline between medical devices and medicinal products under Regulation (EU) 2017/745 on medical devices (MDCG)
- 2021-3 Guidance Questions and Answers on Custom-Made Devices & considerations on Adaptable medical devices and Patient-matched medical devices (MDCG)
- 2019-15 Guidance notes for manufacturers of Class I Medical Devices (MDCG)
- 2019-11 Guidance document on Qualification and Classification of Software in MDR and IVDR (MDCG)
- 2018-3 Guidance on UDI for systems and procedure packs (MDCG and Annex)
- Is your software a medical device? (EC)
- BSI White Paper: Software as a medical device – A comparison of the EU’s approach with the US’s approach (BSI)
- Transitional provisions for consultations of authorities on devices incorporating a substance which may be considered a medicinal product […] as well as on devices manufactured using TSE susceptible animal tissues (MDCG)
- Borderline Manuals from Directive:
- Manual on borderline and classification in the community regulatory framework for medical devices (EC)
- Medical devices - reclassification of products without an intended medical purpose (Consultation open until 08.09.2022)
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