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
Title
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
Directive 89/336/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
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 was taken in use by 1 September 2016.
MEDDEV 2.7/4 (183 kB) Guidelines on clinical investigations: a guide for
manufacturers and notified bodies
December 2010
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
annex 1 (119 kB), annex 2 (14 kB), annex 3 (16 kB), annex 4 (26 kB)
April 2001
2.12
Post-Market
surveillance
MEDDEV 2.12/1 rev.8 (763 kB)
Guidelines on a medical devices vigilance system
January 2013
Additional guidance on MEDDEV 2.12/1 rev.8 (855 kB)
July 2019
Ⅰ. MEDDEV 2.12/1 rev.8 – Latest Version Forms
MEDDEV 2.12 rev. 7 FSCA is still valid
Active PDF forms
New MIR form* - as from January 2020
New manufacturer incident report (PDF form)
New manufacturer incident report for importing XML file* with Adobe
Professional
The published MIR form is password-protected so it may be necessary to
unlock it for specific purposes (e.g. translating the form, implementing it
into in-house IT systems).
You can request the password for specific authorised uses, which are
subject to terms and conditions.
New manufacturer incident report XSD file and XSL files (for
implementation in manufacturer’ databases)
New manufacturer incident report help text
Changelog file
Questions and answers document on the implementation of the new MIR
form
*If you're a manufacturer and have already adapted your IT system to
version 7.2, you may use this version until the end of March 2020.
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 corrective action - FSCA (1 MB)
FSCA xml files
Field safety notice template (105 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
DSVG 00 Introduction to device specific vigilance guidance
DSVG 01 Cardiac ablation vigilance reporting guidance
DSVG 02 Coronary stents vigilance reporting guidance
DSVG 03 Cardiac implantable electronic devices (CIED)
DSVG 04 Breast implants
DSVG 05 Insulin Infusion Pumps and Integrated meter systems
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
guidance
MEDDEV 2.15 rev.3 (32 kB) Committees/working groups contributing to the
implementation of the medical device directives
December 2008