Internal Market, Industry, Entrepreneurship and SMEs

Guidance

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

MDCG 2018-1

Draft guidance on basic UDI-DI and changes to UDI-DI

March 2018

MDCG 2018-2

Future EU medical device nomenclature – Description of requirements

March 2018

MDCG 2018-3Guidance on UDI for systems and procedure packsOctober 2018
MDCG 2018-4Definitions/Descriptions and formats of the UDI core elements for systems or procedure packsOctober 2018
MDCG 2018-5UDI Assignment to Medical Device SoftwareOctober 2018
MDCG 2018-6Clarifications of UDI related responsibilities in relation to Article 16October 2018
MDCG 2018-7Provisional considerations regarding language issues associated with the UDI databaseOctober 2018

 

Designation of notified bodies under the new Regulations on medical devices

Notified BODIESDesignation 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

UDIWG 2018-1

UDI database. Definitions, descriptions and formats of the UDI core elements

March 2018

UDIWG 2018-2

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, definitionMEDDEV 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 requirementsMEDDEV 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 MDMEDDEV 2.4/1 rev.9 (759 kB) Classification of medical devices
June 2010
2.5 Conformity assessment procedureGeneral 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
Clinical investigation, clinical evaluation

MEDDEV 2.7/1 rev.4 (631 kB) Clinical evaluation: Guide for manufacturers and notified bodies
June 2016
Appendix 1: Clinical evaluation on coronary stents (100 kB)
December 2008

 

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
September 2015

 

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)
May 2015

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
December 2010

2.10 Notified bodiesThe 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
Annex 1 (119 kB), Annex 2 (14 kB), Annex 3 (16 kB), Annex 4 (26 kB)
April 2001

2.12
Market surveillance

MEDDEV 2.12/1 rev.8 (763 kB)
Guidelines on a Medical Devices Vigilance System
January 2013

Ⅰ. MEDDEV 2.12/1 rev.8 – Latest Version Forms
MEDDEV 2.12/1 rev. 7 MIR and FSCA are still valid

Active PDF forms
How to use FSCA and MIR forms (12 kB)
Manufacturer Incident Report - MIR (971 kB)
Field Safety Corrective Action - FSCA (1 MB)
MIR and FSCA xml files

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
Field Safety Notice Template (195 kB)
FSN Customer reply (108 kB)
FSN Distributor/Importer reply (103 kB)
FSN Q&A (152 kB)
Trend Report (151 kB)
Periodic Summary Report (192 kB)

Ⅱ. Device Specific Vigilance Guidance

DSVG Template (22 kB)
DSVG 00 (20 kB) Introduction to Device Specific Vigilance Guidance
DSVG 01 (24 kB) Cardiac Ablation Vigilance Reporting Guidance
DSVG 02 (26 kB) Coronary Stents Vigilance Reporting Guidance

 MEDDEV 2.12/2 rev.2 (228 kB) Post Market Clinical Follow-up studies
January 2012
2.13 Transitional periodMEDDEV 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 IVDMEDDEV 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

Informative documents