| 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 equipmentFor the relation between the MDD and Directive 89/686/EEC concerning personal protective equipment, please see the Commission services |
| 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 | GHTF-Part 4: Multiple Site Auditing | Quality assurance.Regulatory auditing of quality systems od medical device manufacturers. (See documents: |
| 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 devicesincorporating products containing natural rubber latex |
| MEDDEV 2.5/10 | Guideline for authorised representatives |
| 2.7 Clinical investigation, clinicalevaluation | MEDDEV 2.7/1 rev. 4 | Clinical evaluation: Guide for manufacturers and notified bodies |
| 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 – |
| 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. |
| 2.12 Post-Market surveillance | MEDDEV 2.12/1 rev. 8 | Guidelines on a medical devices vigilance systemMEDDEV 2.12 rev. 7 FSCA is still validActive PDF formsNew MIR form* – as from January 2020The 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 , which are subject to terms and conditions. (for implementation in manufacturer’ databases)*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: Introduction to device specific vigilance guidance Cardiac ablation vigilance reporting guidance Coronary stents vigilance reporting guidance Cardiac implantable electronic devices (CIED) Breast implants 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) |
| interpretative document of the Commission’s services of 5 June 2009 | As regards the transitional regime of Directive 2007/47/EC see the |
| 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 |
