This is the list of documents referenced in the Entries service.

All European Community legislation referenced and linked in Entries aim to be the latest consolidated versions. Likewise, all guidance documents and websites referenced aim to be the latest versions. We reserve a reasonable time for making updates when new versions are published. The referenced documents can be found from one of the following sources:

The EUR-Lex home page that contains the European Union legislation.

The European Commission medical devices growth sector guidance page for the Current Directives (home e.g. for the MEDDEV’s and the Manual on Borderline) and for the New Regulations (as soon as the relevant guidelines are published).

The International Medical Device Regulators Forum home page.

  1. Medical Device Regulation (MDR) 2017/745
  2. In Vitro Diagnostic Medical Device Regulation (IVDR) 2017/746
  3. Medical Device Directive 93/42/EEC (MDD)
  4. Active Implantable Medical Device Directive 90/385/EEC (AIMDD)
  5. In Vitro Diagnostic Medical Device Directive 98/79/EC (IVDD)
  6. Directive 2003/12/EC on Reclassification of Breast implants
  7. Directive 2005/50/EC on Reclassification of Hip, Knee and Shoulder Joint Replacements
  8. Regulation 722/2012 on Active Implantable Medical Devices and Medical Devices Manufactured Utilising Tissues of Animal Origin
  9. Directive 2001/83/EC relating to Medicinal Products for Human Use
  10. Regulation 726/2004 on the Authorization and Supervision of Medicinal Products for Human and Veterinary Use
  11. Regulation 1394/2007 on Advanced Therapy Medicinal Products
  12. Directive 2004/23/EC on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells
  13. Directive 89/686/EEC relating to Personal Protective Equipment (PPE)
  14. Regulation 528/2012 on Biocidal Products
  15. Regulation 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH)
  16. Directive 80/181/EEC on Units of Measurement
  17. Directive 2015/1535 on Information Society Services
  18. MEDDEV 2.1/1 (Apr 1994) Definitions of “medical devices”, “accessory” and “manufacturer”
  19. MEDDEV 2.1/2 (rev. 2, Apr 1994) Field of application of the AIMDD
  20. MEDDEV 2.1/3 (rev. 3, Dec 2009) Borderline products, drug-delivery products and medical devices incorporating, as an integral part, an ancillary medicinal substance or an ancillary human blood derivative
  21. MEDDEV 2.1/4 (Mar 1994) Interface with other directives – Electromagnetic Compatibility (EMC) and Personal Protective Equipment (PPE)
  22. MEDDEV 2.1/5 (Jun 1998) Medical devices with a measuring function
  23. MEDDEV 2.1/6 (Jul 2016) Qualification and classification of stand alone software
  24. MEDDEV 2.4/1 (rev. 9, Jun 2010) Classification of medical devices
  25. MEDDEV 2.14/1 (rev. 2, Jan 2012) IVD medical device borderline and classification issues
  26. MEDDEV 2.14/2 (rev. 1, Feb 2004) IVD medical devices – Research Use Only (RUO) products
  27. Manual on Borderline and Classification in the Community Regulatory Framework for Medical Devices (ver. 1.22, May 2019)
  28. Interpretative guide of the relation between the MDD and the PPE Directive (21 Aug 2009)
  29. Requirements guide for IVD kits measuring parameters which can be used for evaluating the risk of trisomy 21 (Dec 2006)
  30. Interpretative guide on Placing on the market of medical devices (16 Nov 2010)
  31. The ‘Blue Guide’ on the implementation of EU products rules 2016
  32. EU case law (22 Nov 2012) Brain Products GmbH v BioSemi VOF and Others
  33. EU case law (7 Dec 2017) SNITEM/Philips v Ministre des Affaires sociales et de la Santé, France
  34. GHTF: Principles of In Vitro Diagnostic (IVD) Medical Devices Classification (SG1(PD)/N045R12) (9 Feb 2007)
  35. IMDRF: Software as a Medical Device: Possible Framework for Risk Categorization and Corresponding Considerations
  36. NBOG (Notified Body Operations Group) Documents website
  37. NANDO (New Approach Notified and Designated Organisations) Information System website
  38. ISO 13485:2016 Medical devices – Quality management systems – Requirements for regulatory purposes
  39. MEDDEV 2.7/1 (rev. 4, Jun 2016) Clinical Evaluation: A guide to manufacturers and Notified Bodies under the MDD and the AIMDD
  40. EN 13612:2002 Performance evaluation of in vitro diagnostic medical devices
  41. ISO 14155:2011 Clinical investigation of medical devices for human subjects – Good clinical practice
  42. ISO 14971:2007 Medical devices – Application of risk management to medical devices
  43. IEC 62366-1:2015 Medical devices – Part 1: Application of usability engineering to medical devices
  44. ISO 15223-1:2016 Medical devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General requirements
  45. ISO 18113-1:2009 In vitro diagnostic medical devices – Information supplied by the manufacturer (labelling) – Part 1: Terms, definitions and general requirements
  46. IEC 62304:2006+A1:2015 Medical device software – Software life cycle processes
  47. IEC 82304-1:2016 Health software – Part 1: General requirements for product safety
  48. IEC 60601-1:2005+A1:2012 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
  49. IEC 61010-2-101:2018 Safety requirements for electrical equipment for measurement, control, and laboratory use – Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipments
  50. IEC 61010-1:2010+AMD1:2016 Safety requirements for electrical equipment for measurement, control, and laboratory use – Part 1: General requirements
  51. ISO 10993-1:2018 Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management processs
  52. EN 13532:2002 General requirements for in vitro diagnostic medical devices for self-testing

Phone: +358 20 773 9510

Follow on Twitter@Leanentries

Follow on LinkedinLean Entries Ltd