Library

List of documents referenced on the Entries digital regulatory runways.

All European Community legislation referenced and linked in Entries aim to be the latest consolidated versions. Likewise, all guidance documents, standards and websites referenced aim to be the latest versions. We reserve a reasonable time for making updates when new versions are published. The referenced legislation and guidelines 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.

THE NEW EU MEDICAL DEVICE REGULATIONS

  1. Medical Device Regulation (MDR) 2017/745
  2. In Vitro Diagnostic Medical Device Regulation (IVDR) 2017/746

THE CURRENT EU MEDICAL DEVICE DIRECTIVES

  1. Medical Device Directive 93/42/EEC (MDD)
  2. Active Implantable Medical Device Directive 90/385/EEC (AIMDD)
  3. In Vitro Diagnostic Medical Device Directive 98/79/EC (IVDD)
  4. Directive 2003/12/EC on Reclassification of Breast implants
  5. Directive 2005/50/EC on Reclassification of Hip, Knee and Shoulder Joint Replacements
  6. Regulation 722/2012 on Active Implantable Medical Devices and Medical Devices Manufactured Utilising Tissues of Animal Origin

OTHER RELEVANT EU LEGISLATION FOR SPECIFIC TYPES OF MEDICAL DEVICES

  1. Directive 2001/83/EC relating to Medicinal Products for Human Use
  2. Regulation 726/2004 on the Authorization and Supervision of Medicinal Products for Human and Veterinary Use
  3. Regulation 1394/2007 on Advanced Therapy Medicinal Products
  4. 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
  5. Directive 89/686/EEC relating to Personal Protective Equipment (PPE)
  6. Regulation 528/2012 on Biocidal Products
  7. Regulation 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH)
  8. Directive 80/181/EEC on Units of Measurement
  9. Directive 2015/1535 on Information Society Services

GUIDANCE DOCUMENTS PUBLISHED BY THE EUROPEAN COMMISSION

  1. MEDDEV 2.1/1 (Apr 1994) Definitions of “medical devices”, “accessory” and “manufacturer”
  2. MEDDEV 2.1/2 (rev. 2, Apr 1994) Field of application of the AIMDD
  3. 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
  4. MEDDEV 2.1/4 (Mar 1994) Interface with other directives – Electromagnetic Compatibility (EMC) and Personal Protective Equipment (PPE)
  5. MEDDEV 2.1/5 (Jun 1998) Medical devices with a measuring function
  6. MEDDEV 2.1/6 (Jul 2016) Qualification and classification of stand alone software
  7. MEDDEV 2.4/1 (rev. 9, Jun 2010) Classification of medical devices
  8. MEDDEV 2.14/1 (rev. 2, Jan 2012) IVD medical device borderline and classification issues
  9. MEDDEV 2.14/2 (rev. 1, Feb 2004) IVD medical devices – Research Use Only (RUO) products
  10. Manual on Borderline and Classification in the Community Regulatory Framework for Medical Devices (ver. 1.22, May 2019)
  11. Interpretative guide of the relation between the MDD and the PPE Directive (21 Aug 2009)
  12. Requirements guide for IVD kits measuring parameters which can be used for evaluating the risk of trisomy 21 (Dec 2006)
  13. Interpretative guide on Placing on the market of medical devices (16 Nov 2010)
  14. The ‘Blue Guide’ on the implementation of EU products rules 2016

RELEVANT EU CASE LAW

  1. EU case law (22 Nov 2012) Brain Products GmbH v BioSemi VOF and Others
  2. EU case law (7 Dec 2017) SNITEM/Philips v Ministre des Affaires sociales et de la Santé, France

GUIDANCE DOCUMENTS PUBLISHED BY THE INTERNATIONAL MEDICAL DEVICE REGULATORS FORUM

  1. GHTF: Principles of In Vitro Diagnostic (IVD) Medical Devices Classification (SG1(PD)/N045R12) (9 Feb 2007)
  2. IMDRF: Software as a Medical Device: Possible Framework for Risk Categorization and Corresponding Considerations

SOURCES FOR BROWSING THE SCOPE OF COMPETENCE OF NOTIFIED BODIES

  1. NBOG (Notified Body Operations Group) Documents website
  2. NANDO (New Approach Notified and Designated Organisations) Information System website

CENTRAL MEDICAL DEVICE STANDARDS AND GUIDELINES

  1. ISO 13485:2016 Medical devices – Quality management systems – Requirements for regulatory purposes
  2. MEDDEV 2.7/1 (rev. 4, Jun 2016) Clinical Evaluation: A guide to manufacturers and Notified Bodies under the MDD and the AIMDD
  3. EN 13612:2002 Performance evaluation of in vitro diagnostic medical devices
  4. ISO 14155:2011 Clinical investigation of medical devices for human subjects – Good clinical practice
  5. ISO 14971:2007 Medical devices – Application of risk management to medical devices
  6. IEC 62366-1:2015 Medical devices – Part 1: Application of usability engineering to medical devices
  7. ISO 15223-1:2016 Medical devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General requirements
  8. ISO 18113-1:2009 In vitro diagnostic medical devices – Information supplied by the manufacturer (labelling) – Part 1: Terms, definitions and general requirements
  9. IEC 62304:2006+A1:2015 Medical device software – Software life cycle processes
  10. IEC 82304-1:2016 Health software – Part 1: General requirements for product safety
  11. IEC 60601-1:2005+A1:2012 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
  12. 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
  13. IEC 61010-1:2010+AMD1:2016 Safety requirements for electrical equipment for measurement, control, and laboratory use – Part 1: General requirements
  14. ISO 10993-1:2018 Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management processs
  15. EN 13532:2002 General requirements for in vitro diagnostic medical devices for self-testing
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