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
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| 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
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| 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
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| MEDDEV 2.7/2 rev. 2 |
| MEDDEV 2.7/3 rev. 3 SAE reporting form
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| MEDDEV 2.7/4 |
2.10 Notified bodies | MEDDEV 2.10/2 rev. 1 Annex 1 Annex 2 Annex 3 Annex 4
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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 |