| 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 |
