Single-use devices – In particular MDR Article 17, Annex I 23.2. (n), 23.4. (p), Annex VI Part C 3.9
Systems & Procedure packs – In particular MDR Article 22, 29.2., Annex VI Part C 3. 7., 6.3.,
Custom-made devices – In particular MDR Article 10.5., 15.1., 21, 52.8., 86.1., Annex I 23.2. (p), 23.3. (g), Annex XIII
Investigational devices – In particular MDR Article 15.3. (e), 21, 52.13., 62.4. (l), 70.7., 71.3., 80, Annex XV
Software – In particular Annex I 14.2., 17, 23.4., Annex II 1.1.j, 6.1., Annex VI Part C, Annex VIII 3.3.-3.4., Mainly Rule 11
Device with a medicinal substance – In particular MDR Article 1.8.-9. 4.4.,54.1.b, 71.3g, 7., 89.6., 117, Annex I 10.3., 12, 23.2., 23.4. s & t, Annex II 6.2., Annex VI, , Annex VIII Rule 6,8,12, 14, 20, Annex IX 5.2.,5.4, 6, Annex XI 8, 16, Annex XIII, Annex XV 1.10, 2.6.
Devices without a medical purpose MDR – In particular Article 1.2.-5., Annex XVI
Implantable devices – In particular MDR Article 10.8., 18, 27.8-9., 32, 52.4-5.& 8., 54.1, 61.4.& 6.& 8.& 11, 86.2., 108, 123.3. (f) (g), Annex I 19., 23.2. (s), 23.4. (f), Annex VI 2.14., 6.1., Annex VIII Rule 8, 9, 15, Annex IX 5.1., 7., Annex X 7., Annex XI 9., 17., Annex XIII 4. , Annex XV 3.15. , Chapter III 3.
- Checklist for EN 17466 & Validation (Instructions for use for reusable & re-sterilisable medical devices (COEN) – MDD only
- 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)
- MDCG Guidance on Clinical Evaluation (MDR) / Performance Evaluation (IVDR) of Medical Device Software (IVDR) (MDCG)
- MDCG Guidance on Cybersecurity for medical devices (MDCG)
- Principles and Practices for Medical Device Cybersecurity (IMDRF)
- Personalized Medical Devices – Regulatory Pathways (IMDRF)
- European Medicines Agency Questions & Answers on Implementation of MDR and IVDR (EMA)
- MDCG Guidance on Qualification and Classification of Software (MDCG)
- ANSM (French authority) Guideline – Cybersecurity of medical devices integrating software during their life cycle
- 1-pager on Software and Artificial Intelligence (SNITEM)
- MHRA Guidance for manufacturers on Annex XVI devices (MHRA)