Guidance
The European Commission provides a range of guidance documents to assist stakeholders in implementing directives related to medical devices.
New regulations
Guidance documents to assist stakeholders in implementing the Medical Devices Regulations.
MDCG documents
MDCG endorsed documents
Reference | Title | Publication date |
Draft guidance on basic UDI-DI and changes to UDI-DI | March 2018 | |
Future EU medical device nomenclature – Description of requirements | March 2018 | |
| MDCG 2018-3 | Guidance on UDI for systems and procedure packs | October 2018 |
| MDCG 2018-4 | Definitions/Descriptions and formats of the UDI core elements for systems or procedure packs | October 2018 |
| MDCG 2018-5 | UDI Assignment to Medical Device Software | October 2018 |
| MDCG 2018-6 | Clarifications of UDI related responsibilities in relation to Article 16 | October 2018 |
| MDCG 2018-7 | Provisional considerations regarding language issues associated with the UDI database | October 2018 |
Designation of notified bodies under the new Regulations on medical devices
| Notified BODIES | Designation of notified bodies under the new Regulations on medical devices |
|---|---|
| 1. Best practice guidance on designation and notification of conformity assessment bodies (NBOG BPG 2017-1) | |
| 2. Best practice guidance on the information required for conformity assessment bodies' personnel involved in conformity assessment activities (NBOG BPG 2017-2) | |
| 3. Application form to be submitted by a conformity assessment body when applying for designation as notified body under the medical devices Regulation (MDR) (NBOG F 2017-1) | |
| 4. Application form to be submitted by a conformity assessment body when applying for designation as notified body under the in vitro diagnostic devices Regulation (IVDR) (NBOG F 2017-2) | |
| 5. Applied-for scope of designation and notification of a conformity assessment body – Regulation (EU) 2017/745 (MDR) (NBOG F 2017-3) | |
| 6. Applied-for scope of designation and notification of a conformity assessment body – Regulation (EU) 2017/746 (IVDR) (NBOG F 2017-4) | |
| 7. Preliminary assessment review template (MDR) (NBOG F 2017-5) | |
| 8. Preliminary assessment review template (IVDR) (NBOG F 2017-6) | |
| 9. Review of qualification for the authorisation of personnel (MDR) (NBOG F 2017-7) | |
| 10. Review of qualification for the authorisation of personnel (IVDR) (NBOG F 2017-8) |
Other documents
Reference | Title | Publication date |
UDI database. Definitions, descriptions and formats of the UDI core elements | March 2018 | |
The architecture of the UDI database - Basic UDI-DI and UDI-DI attributes for medical devices and in-vitro diagnostic medical devices | March 2018 |
Current legislation
Guidance documents to assist stakeholders in implementing directives related to medical devices.
Guidance MEDDEVs
The MEDDEVs promote a common approach to be followed by manufacturers and Notified Bodies that are involved in conformity assessment procedures.
- The MEDDEVs are drafted by authorities charged with safeguarding public health in conjunction with all stakeholders; industry associations, health professionals associations, Notified Bodies and European Standardisation Organisations. This is in accordance with the relevant annexes of the directives
- MEDDEVs are carefully drafted through a consultation process with all interested parties and are subject to a regular updating process
- These documents have particular reference codes and are endorsed at the Medical Devices Expert Group (MDEG) plenary meetings
- The guidelines are not legally binding. However, due to the participation of the aforementioned interested parties and the experts from competent authorities, it is expected that the guidelines be followed, ensuring the uniform application of relevant directive provisions.
Disclaimer: Please note that the amendments introduced by Directive 2007/47/EC or previous amending directives have not yet been incorporated into all MEDDEVs.
List of Guidance MEDDEVs
See below a complete list of all Guidance Meddevs, including links to further information:
| Title | |
|---|---|
| 2.1 Scope, field of application, definition | MEDDEV 2.1/1 (18 kB) Definitions of “medical devices”, “accessory” and “manufacturer” April 1994 |
| MEDDEV 2.1/2 rev.2 (14 kB) Field of application of directive “active implantable medical devices” April 1994 | |
| MEDDEV 2.1/2.1 (12 kB) Treatment of Computers Used to Program Implantable Pulse Generators February 1998 | |
| MEDDEV 2.1/3 rev.3 (183 kB) Borderline products, drug-delivery products and medical devices incorporating,as integral part, an ancillary medicinal substance or an ancillary human blood derivative December 2009 | |
| MEDDEV 2.1/4 (21 kB) Interface with other directives – Medical devices/directive89/336/EEC relating to electromagnetic compatibility and directive 89/686/EEC relating to personal protective equipment March 1994 For the relation between the MDD and directive 89/686/EEC concerning personal protective equipment, please see the Commission services interpretative document of 21 August 2009 (28 kB) | |
| MEDDEV 2.1/5 (10 kB) Medical devices with a measuring function June 1998 | |
| MEDDEV 2.1/6 (514 kB) Qualification and Classification of stand alone software July 2016 |
| 2.2 Essential requirements | MEDDEV 2.2/1 rev.1 (16 kB) EMC requirements February 1998 |
|---|---|
| MEDDEV 2.2/3 rev.3 (17 kB) “Use by”-date June 1998 | |
| MEDDEV 2.2/4 (38 kB) Conformity assessment of In Vitro Fertilisation (IVF) and Assisted Reproduction Technologies (ART) products January 2012 |
| 2.4 Classification of MD | MEDDEV 2.4/1 rev.9 (759 kB) Classification of medical devices June 2010 |
|---|
| 2.5 Conformity assessment procedure | General rules |
|---|---|
| Quality assurance. Regulatory auditing of quality systems of medical device manufacturers (See document in the GHTF-Global Harmonization Task Force) | |
| MEDDEV 2.5/3 rev.2 (8 kB) Subcontracting quality systems related June 1998 | |
| MEDDEV 2.5/5 rev.3 (7 kB) Translation procedure February 1998 | |
| MEDDEV 2.5/6 rev.1 (9 kB) Homogenous batches (verification of manufacturers' products) February 1998 | |
| Conformity assessment for particular groups of products | |
| MEDDEV 2.5/7 rev.1 (92 kB) Conformity assessment of breast implants July 1998 | |
| MEDDEV 2.5/9 rev.1 (96 kB) Evaluation of medical devices incorporating products containing natural rubber latex February 2004 | |
| MEDDEV 2.5/10 (80 kB) Guideline for Authorised Representatives January 2012 |
2.7 | MEDDEV 2.7/1 rev.4 (631 kB) Clinical evaluation: Guide for manufacturers and notified bodies |
MEDDEV 2.7/2 rev. 2 (412 kB) Guidelines for Competent Authorities for making a validation/assessment of a clinical investigation application under directives 90/385/EEC and 93/42/EC | |
MEDDEV 2.7/3 rev. 3 (383 kB) Clinical investigations: serious adverse reporting under directives 90/385/EEC and 93/42/EC - SAE reporting form (27 kB) The new SAE reporting form will be taken in use 1 September 2016 at the latest. | |
MEDDEV 2.7/4 (183 kB) Guidelines on Clinical investigations: a guide for manufacturers and notified bodies |
| 2.10 Notified bodies | The documents on designation of notified bodies under the new Regulations are in the section above (MDCG documents) |
|---|---|
MEDDEV 2.10/2 rev.1 (105 kB) Designation and monitoring of Notified Bodies within the framework of EC Directives on Medical devices |
| 2.12 Market surveillance | MEDDEV 2.12/1 rev.8 (763 kB) Ⅰ. MEDDEV 2.12/1 rev.8 – Latest Version Forms Active PDF forms Please note: Some browser plugins are not compatible with PDF forms. If you have problems opening these forms, please save them to your computer and open them from there. Other forms and templates Ⅱ. Device Specific Vigilance Guidance DSVG Template (22 kB) |
|---|---|
| MEDDEV 2.12/2 rev.2 (228 kB) Post Market Clinical Follow-up studies January 2012 |
| 2.13 Transitional period | MEDDEV 2.13 rev.1 Commission communication on the application of transitional provision of Directive 93/42/EEC relating to medical devices (OJ 98/C 242/05) August 1998 |
|---|---|
| As regards the transitional regime of Directive 2007/47/EC see the Interpretative Document of the Commission's services of 5 June 2009 (35 kB) |
| 2.14 IVD | MEDDEV 2.14/1 rev.2 (76 kB) Borderline and Classification issues. A guide for manufacturers and notified bodies January 2012 |
|---|---|
| MEDDEV 2.14/2 rev.1 (64 kB) Research Use Only products February 2004 | |
| MEDDEV 2.14/3 rev.1 (80 kB) Supply of Instructions For Use (IFU) and other information for In-vitro Diagnostic (IVD)Medical Devices January 2007 | |
| Form for the registration of manufacturers and devices In Vitro Diagnostic Medical Device Directive, Article 10 (213 kB) January 2007 | |
| MEDDEV 2.14/4 (114 kB) CE marking of blood based in vitro diagnostic medical devices for vCJD based on detection of abnormal PrP January 2012 |
| 2.15 Other guidances | MEDDEV 2.15 rev.3 (32 kB) Committees/Working Groups contributing to the implementation of the Medical Device Directives December 2008 |
|---|
Consensus statements
- Guidance Notes for Manufacturers of Class Ⅰ Medical Devices (52 kB) endorsed by the MDEG on December 2009
- Guidance Notes for Manufacturers of Custom-Made Medical Devices (51 kB) endorsed by the MDEG on June 2010
- Guidance document on Dir. 2005/50/EC (32 kB) endorsed by the MDEG on December 2006
- IVD Trisomy 21 (13 kB) endorsed by the MDEG on December 2006
- IVD Rare Blood Groups (20 kB) endorsed by the MDEG on December 2003
Informative documents
- Informative document of the Commission’s services on placing on the market of medical devices (16 November 2010, 30 kB)
- Information on the Customs Union Agreement with Turkey in the field of medical devices (11 February 2010, 32 kB)
- Decision No 1/2006 of the EC-Turkey Association Council of 15 May 2006 on the implementation of Article 9 of Decision No 1/95 of the EC-Turkey Association Council on implementing the final phase of the Customs Union
- Statement of Turkey – EC Customs Union Joint Committee on the implementation of Article 1 of Decision 1/2006 (88 kB)
- Information on the relation between the revised Directives 90/385/EEC and 93/42/EEC concerning (active implantable) medical devices and Directive 2006/42/EC on machinery (21 August 2009, 21 kB)
- Information on the relation between the revised Directive 93/42/EEC concerning medical devices and Directive 89/686/EEC on personal protective equipment (21 August 2009, 28 kB)
- Informative document of the Commission’s services on implementation of directive 2007/47/EC amending directives 90/385/EEC, 9342/EEC and 98/8/EC (5 June 2009, 35 kB)
- Information on the Medical Devices Directives in relation to medical device own brand labellers (4 February 2008, 17 kB)