| Description | Reference |
2.1 Scope, field of application,
definition | MEDDEV 2.1/1 |
| MEDDEV 2.1/2 rev. 2 |
| MEDDEV 2.1/2.1 |
| MEDDEV 2.1/3 rev. 3 |
| MEDDEV 2.1/4
Interpretative document of 21
August 2009
|
| MEDDEV 2.1/5 |
| MEDDEV 2.1/6 |
| 2.2 Essential requirements | MEDDEV 2.2/1 rev. 1 |
| MEDDEV 2.2/3 rev. 3 |
| MEDDEV 2.2/4 |
| 2.4 Classification of MD | MEDDEV 2.4/1 rev. 9 |
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 |
| MEDDEV 2.5/5 rev. 3 |
| MEDDEV 2.5/6 rev. 1 |
| MEDDEV 2.5/7 rev. 1 |
| MEDDEV 2.5/9 rev. 1 |
| MEDDEV 2.5/10 |
2.7 Clinical investigation, clinical
evaluation | MEDDEV 2.7/1 rev. 4
Appendix 1: Clinical evaluation on coronary stents
|
| MEDDEV 2.7/2 rev. 2 |
| MEDDEV 2.7/3 rev. 3
SAE reporting form
|
| MEDDEV 2.7/4 |
| 2.10 Notified bodies | MEDDEV 2.10/2 rev. 1
Annex 1
Annex 2
Annex 3
Annex 4
|
| 2.12 Post-Market surveillance | MEDDEV 2.12/1 rev. 8
I. MEDDEV 2.12/1 rev. 8 – Latest
Version Forms
MEDDEV 2.12 rev. 7 MIR and FSCA are still valid
Active PDF forms
How to use FSCA and MIR forms
(* due form mancanti)
Other forms and templates
Field safety notice template
FSN customer reply
FSN distibrutor/importer reply
FSN Q&A
Trend report
Periodic summary report
II. Device Specific Vigilance
Guidance
DSVG Template
DSVG 00
DSVG 01
DSVG 02
New MIR form – as from
January 2019
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.
Other forms and templates
Field safety corrective action – FSCA (1 MB)
FSCA xml files
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
DSVG 03 (250 kB) Cardiac implantable electronic devices (CIED)
DSVG 04 (219 kB) Breast implants |
| MEDDEV 2.12/2 rev. 2 |
| 2.13 Transitional period | MEDDEV 2.13 rev. 1 |
| 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 |
| MEDDEV 2.14/2 rev. 1 |
| MEDDEV 2.14/3 rev. 1 |
| Form for the registration of manufacturers and devices in vitro diagnostic medical device directive, article 10 |
| MEDDEV 2.14/4 |
| 2.15 Other guidances | MEDDEV 2.15 rev 3 |