Description

Reference

2.1 Scope, field of application,
definition

MEDDEV 2.1/1 Definitions of ‘medical devices’, ‘accessory’ and ‘manufacturer’

MEDDEV 2.1/2 rev. 2 Field of application of directive ‘active implantable medical devices’

MEDDEV 2.1/2.1 Treatment of computers used to program implantable pulse generators

MEDDEV 2.1/3 rev. 3 Borderline products, drug-delivery products and medical devices incorporating, as integral part, an ancillary medicinal substance or an ancillary human blood derivative

MEDDEV 2.1/4 Interface with other directives – Medical devices Directive 89/336/EEC relating to electromagnetic compatibility and Directive 89/686/EEC relating to personal protective equipment
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

MEDDEV 2.1/5 Medical devices with a measuring function

MEDDEV 2.1/6 Qualification and classification of stand alone software

2.2 Essential requirements

MEDDEV 2.2/1 rev. 1 EMC requirements

MEDDEV 2.2/3 rev. 3 ‘Use by’-date

MEDDEV 2.2/4 Conformity assessment of in vitro fertilisation (IVF) and assisted reproduction technologies (ART) products

2.4 Classification of MD

MEDDEV 2.4/1 rev. 9 Classification of medical devices

2.5 Conformity assessment
procedure

Quality assurance.
Regulatory auditing of quality systems od medical device manufacturers.
(See documents:
GHTF-Part 4: Multiple Site Auditing
GHTF-Part 5: Audits of Manufacturer Control of Supplies

MEDDEV 2.5/3 rev. 2 Subcontracting quality systems related

MEDDEV 2.5/5 rev. 3 Translation procedure

MEDDEV 2.5/6 rev. 1 Homogenous batches (verification of manufacturers’ products)

MEDDEV 2.5/7 rev. 1 Conformity assessment of breast implants

MEDDEV 2.5/9 rev. 1 Evaluation of medical devices
incorporating products containing natural rubber latex

MEDDEV 2.5/10 Guideline for authorised representatives

2.7 Clinical investigation, clinical
evaluation

MEDDEV 2.7/1 rev. 4 Clinical evaluation: Guide for manufacturers and notified bodies
Appendix 1: Clinical evaluation on coronary stents

MEDDEV 2.7/2 rev. 2 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 Clinical investigations: serious adverse reporting under Directives 90/385/EEC and 93/42/EC – SAE reporting form

MEDDEV 2.7/4 Guidelines on clinical investigations: a guide for manufacturers and notified bodies

2.10 Notified bodies

MEDDEV 2.10/2 rev. 1 Designation and monitoring of notified bodies within the framework of EC directives on medical devices.
Annex 1
Annex 2
Annex 3
Annex 4

2.12 Post-Market surveillance

MEDDEV 2.12/1 rev. 8
Guidelines on a medical devices vigilance system

Additional guidance on MEDDEV 2.12/1 rev.8

1) MEDDEV 2.12/1 rev. 8 – Latest Version Form
MEDDEV 2.12 rev. 7 FSCA is still valid

Active PDF forms
New MIR form* – as from January 2020
New manufacturer incident report
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.

How to use FSCA and MIR forms

Other forms and templates:
Field safety notice template
FSN customer reply
FSN distibrutor/importer reply
FSN Q&A
Trend report
Periodic summary report

2) 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 Post market clinical follow-up studies

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)

As regards the transitional regime of Directive 2007/47/EC see the
interpretative document of the Commission’s services of 5 June 2009

2.14 IVD

MEDDEV 2.14/1 rev. 2 Borderline and classification issues. A guide for manufacturers and notified bodies

MEDDEV 2.14/2 rev. 1 Research use only products

MEDDEV 2.14/3 rev. 1 Supply of instructions for use (IFU) and other information for in-vitro diagnostic (IVD) medical devices

Form for the registration of manufacturers and devices in vitro diagnostic medical device directive, article 10

MEDDEV 2.14/4 CE marking of blood based in vitro diagnostic medical devices for vCJD based on detection of abnormal PrP

2.15 Other guidances

MEDDEV 2.15 rev 3 Committees/working groups contributing to the implementation of the medical device directives