Library

List of documents referenced in the Entries services for the Health Tech sector.

All European Community medical device related legislation referenced 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 guidance page.

• Direct link to MDCG guidance documents related to MDR and IVDR
• Direct link to MEDDEV guidance documents related to MDD, AIMDD and IVDD

The International Medical Device Regulators Forum home page.

Access to EUDAMED – European Database on Medical Devices.

For additional guidance, see also the book European Medical Device Regulations MDR & IVDR – A Guide to Market, a Dec 2020 publication by Business Finland for the Finnish health tech sector with Lean Entries as one of the authors.

THE NEW EU MEDICAL DEVICE REGULATIONS

1. Medical Device Regulation (MDR) 2017/745
   • Table of Contents for the MDR (pdf, by Lean Entries)
   • Harmonised Standards for the MDR
   • General Safety & Performance Checklist template (xlsx/sheet 1, by Lean Entries)
2. In Vitro Diagnostic Medical Device Regulation (IVDR) 2017/746
   • Table of Contents for the IVDR (pdf, by Lean Entries)
   • Harmonised Standards for the IVDR
   • General Safety & Performance Checklist template (xlsx/sheet 2, by Lean Entries)

THE OLD EU MEDICAL DEVICE DIRECTIVES

1. Medical Device Directive 93/42/EEC (MDD)
   • Table of Contents for the MDD (pdf, by Lean Entries)
   • Harmonised Standards for the MDD
2. Active Implantable Medical Device Directive 90/385/EEC (AIMDD)
   • Table of Contents for the AIMDD (pdf, by Lean Entries)
   • Harmonised Standards for the AIMDD
3. In Vitro Diagnostic Medical Device Directive 98/79/EC (IVDD) 
   • Table of Contents for the IVDD (pdf, by Lean Entries)
   • Harmonised Standards for the 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 POTENTIALLY RELEVANT EU LEGISLATION

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. Regulation 2016/425 on 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 RELEVANT FOR THE NEW EU MEDICAL DEVICE REGULATIONS (QUALIFICATION & CLASSIFICATION)

1. MDCG 2019-11 (Oct 2019) – Guidance on Qualification and Classification of Software in MDR and IVDR
2. MDCG 2019-15 (Dec 2019) – Guidance Notes for Manufacturers of Class I Medical Devices
3. MDCG 2020-16 (Jul 2024) – Guidance on Classification Rules for in vitro Diagnostic Medical Devices under IVDR
4. MDCG 2021-24 (Oct 2021) – Guidance on Classification of Medical Devices
5. MDCG 2022-5 (Apr 2022) – Guidance on Borderline between Medical Devices and Medicinal Products under MDR
6. MDCG 2023-5 (Dec 2023) – Guidance on Qualification and Classification of Annex XVI Products
7. Manual on borderline and classification for medical devices under MDR and IVDR (ver. 2, Dec 2022)
8. Background note on the use of the Manual on borderline and classification for medical devices under the Directives
9. The European Medicines Agency (EMA) website for MDR & IVDR related guidance

GUIDANCE DOCUMENTS RELEVANT FOR THE NEW EU MEDICAL DEVICE REGULATIONS (CLINICAL INVESTIGATIONS)

1. MDCG 2021-8 (May 2021) – Clinical Investigation Application/Notification Documents
2. MDCG 2021-6 (Apr 2021) – Regulation (EU) 2017/745 (MDR) – Questions & Answers Regarding Clinical Investigation
3. MDCG 2020-13 (Jul 2020) – Clinical Evaluation Assessment Report Template

GUIDANCE DOCUMENTS RELEVANT FOR THE OLD EU MEDICAL DEVICE DIRECTIVES

Note: The European Commission website may claim the their server is inaccessible to download the following documents (except for the ‘Blue Guide’). As soon as we notice these documents are accessible, we will remove this note.

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 2022

EU CASE LAW IN RELATION TO THE OLD EU MEDICAL DEVICE DIRECTIVES

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 BY THE INTERNATIONAL MEDICAL DEVICE REGULATORS FORUM (IMDRF)

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

SCOPE OF COMPETENCE OF NOTIFIED BODIES

1. NANDO (New Approach Notified and Designated Organisations) Information System website
2. Regulation 2017/2185 on Notified Body scope expression codes
3. MDCG 2019-14 (Dec 2019) – Explanatory note on MDR codes
4. MDCG 2021-14 (Dec 2019) – Explanatory note on IVDR codes
5. MDCG guidance documents for Notified Bodies

KEY MEDICAL DEVICE STANDARDS AND GUIDELINES

1. ISO 13485:2016 – Medical devices – Quality management systems – Requirements for regulatory purposes
2. MDCG 2020-1 – Guidance on clinical evaluation (MDR) / Performance evaluation (IVDR) of medical device software
3. MEDDEV 2.7/1 (rev. 4, Jun 2016) – Clinical Evaluation: A guide to manufacturers and Notified Bodies under the MDD and the AIMDD 
4. ISO 20916:2019 In vitro diagnostic medical devices — Clinical performance studies using specimens from human subjects — Good study practice
5. EN 13612:2002 – Performance evaluation of in vitro diagnostic medical devices
6. ISO 14155:2020 – Clinical investigation of medical devices for human subjects – Good clinical practice
7. ISO 14971:2019 – Medical devices – Application of risk management to medical devices
8. IEC 62366-1:2015+A1:2020 – Medical devices – Part 1: Application of usability engineering to medical devices
9. ISO 15223-1:2016 – Medical devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General requirements
10. ISO 18113-1:2009 – In vitro diagnostic medical devices – Information supplied by the manufacturer (labelling) – Part 1: Terms, definitions and general requirements
11. IEC 62304:2006+A1:2015 – Medical device software – Software life cycle processes
12. IEC 82304-1:2016 – Health software – Part 1: General requirements for product safety
13. IEC 60601-1:2005+A1:2012+A2:2020 – Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
14. 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
15. IEC 61010-1:2010+AMD1:2016 – Safety requirements for electrical equipment for measurement, control, and laboratory use – Part 1: General requirements
16. ISO 10993-1:2018 – Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management processs
17. EN 13532:2002 – General requirements for in vitro diagnostic medical devices for self-testing
18. ISO/TR 20416:2020 – Medical devices – Post-market surveillance for manufacturers