| 93/42/EEC | Medical Devices Directive (MDD) | D | 1 | 1993-06-14 | Will be replaced by MDR 26 may 2021 |
| Consensus Statement 2007-12-01 | Guidance document on Dir. 2005/50/EC. | TR | NA- | 2007-01-12 | -- |
| Consensus Statement 2009-06-03 Rev.1 | EU Consensus Statements - Guidance Notes for Manufacturers of Class I Medical Devices. | TR | 2 | 2009-06-03 | -- |
| Consensus Statement 2009-11-11 | Guidance Notes for Manufacturers of Custom-Made Medical Devices. | TR | NA- | 2009-11-11 | -- |
| Current standards | Refer to standards list under Medical Devices Regulation for an overview of current standards | | NA- | -- | -- |
| EN-IEC 60601-2-49 | Medical electrical equipment - Part 2-49: Particular requirements for basic safety and essential performance of multifunction patient monitoring equipment | H , P | NA- | 2001-01-01 | Replaced by EN-IEC 80601-2-49:2019 (not harmonized) |
| European standards | Updated list of harmonised standards | | NA- | 2017-11-17 | -- |
| GD207 | Guidance on the Content of ISO/IEC 13485 Quality Management System Certificates Issued by Health Canada Recognized Registrars | TR | 2 | 2017-03-14 | -- |
| IMDRF documents | Several documents of IMDRF (formerly GHTF) | TR | n/a | 2013-12-18 | -- |
| Interpretative document 2008-02-04 | Interpretation of the Medical Devices Directives in relation to medical device own brand labellers. | TR | NA- | 2008-02-04 | -- |
| Interpretative document 2009-06-05 | Interpretative document of the Commission's services on implementation of directive 2007/47/EC amending directives 90/385/EEC, 9342/EEC and 98/8/EC. | TR | NA- | 2009-06-05 | -- |
| Interpretative document 2009-08-21 | Interpretation of the relation between the revised Directive 93/42/EEC concerning medical devices and Directive 89/686/EEC on personal protective equipment. | TR | NA- | 2009-08-21 | -- |
| Interpretative document 2009-08-21 | Interpretation of the relation between the revised Directives 90/385/EEC and 93/42/EEC concerning (active implantable) medical devices and Directive 2006/42/EC on machinery. | TR | NA- | 2009-08-21 | -- |
| Interpretative document 2010-10-16 | Interpretative document of the Commission's services on placing on the market of medical devices. | TR | NA- | 2010-10-16 | -- |
| MEDDEV 2.1/1 | Definitions of "medical devices", "accessory" and "manufacturer" | TR | 1 | 1994-04-01 | -- |
| MEDDEV 2.1/2.1 | Treatment of computers used to program implantable pulse generators. | TR | 1 | 1998-02-01 | -- |
| 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. | TR | 4 | 2009-12-01 | -- |
| MEDDEV 2.1/4 | Interface with other directives - Medical devices/directive89/336/EEC relating to electromagnetic compatibility and directive 89/686/EEC relating to personal protective equipment. | TR | 1 | 1994-03-01 | -- |
| MEDDEV 2.1/5 | Medical devices with a measuring function. | TR | 1 | 1998-06-01 | -- |
| MEDDEV 2.1/6 | Qualification and Classification of stand alone software. | TR | 1 | 2012-01-01 | -- |
| MEDDEV 2.10/2 rev.1 | Designation and monitoring of Notified Bodies within the framework of EC Directives on Medical devices. | TR | 2 | 2001-04-01 | -- |
| MEDDEV 2.11/1 rev.2 | Application of Council Directive 93/42/EEC taking into account the Commission Directive 2003/32/EC for Medical Devices utilising tissues or derivatives originating from animals for which a TSE risk is suspected. | TR | 3 | 2008-01-01 | -- |
| MEDDEV 2.12/1 rev.8 | Medical Devices Vigilance System | TR | 9 | 2013-01-01 | -- |
| MEDDEV 2.12/2 rev.2 | Post Market Clinical Follow-up studies. | TR | 3 | 2012-01-01 | -- |
| 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). | TR | 2 | 1998-08-01 | -- |
| MEDDEV 2.15 rev.3 | Committees/Working Groups contributing to the implementation of the Medical Device Directives. | TR | 4 | 2008-12-01 | -- |
| MEDDEV 2.2/1 rev.1 | EMC requirements. | TR | 2 | 1998-02-01 | -- |
| MEDDEV 2.2/3 rev.3 | "Use by" - date. | TR | 4 | 1998-06-01 | -- |
| MEDDEV 2.4/1 rev.9 | Classification of medical devices. | TR | 10 | 2010-06-01 | -- |
| MEDDEV 2.5/10 | Guideline for Authorised Representatives. | TR | 1 | 2012-01-01 | -- |
| MEDDEV 2.5/3 rev.2 | Subcontracting quality systems related. | TR | 3 | 1998-06-01 | -- |
| MEDDEV 2.5/5 rev.3 | Translation procedure. | TR | 4 | 1998-02-01 | -- |
| MEDDEV 2.5/6 rev.1 | Homogenous batches (verification of manufacturers' products). | TR | 2 | 1998-02-01 | -- |
| MEDDEV 2.5/9 rev.1 | Evaluation of medical devices incorporating products containing natural rubber latex. | TR | 2 | 2004-02-01 | -- |
| MEDDEV 2.7/1 rev.4 | Clinical evaluation: Guide for manufacturers and notified bodies. | TR | 5 | 2016-06-01 | -- |
| MEDDEV 2.7/3 rev. 3 | Clinical investigations: serious adverse reporting under directives 90/385/EEC and 93/42/EC | TR | 1 | 2015-05-01 | -- |
| MEDDEV 2.7/4 | Guidelines on Clinical investigations: a guide for manufacturers and notified bodies. | TR | 1 | 2010-12-01 | -- |
| NBOG BPG 2006-1 | Change of Notified Body. | TR | NA- | 2008-11-01 | -- |
| NBOG BPG 2009-1 | Guidance on Design-Dossier Examination and Report Content. | TR | NA- | 2009-03-01 | -- |
| NBOG BPG 2009-2 | Role of Notified Bodies in the Medical Device Vigilance System. | TR | NA- | 2009-03-01 | -- |
| NBOG BPG 2009-3 | Guideline for Designating Authorities to Define the Notification Scope of a Notified Body Conducting Medical Devices Assessment. | TR | NA- | 2009-03-01 | -- |
| NBOG BPG 2009-4 | Guidance on Notified Body's Tasks of Technical Documentation Assessment on a Representative Basis. | TR | NA- | 2009-07-01 | -- |
| NBOG BPG 2010-1 | Guidance for Notified Bodies auditing suppliers to medical device manufacturers. | TR | NA- | 2010-03-01 | -- |
| NBOG BPG 2010-2 | Guidance on Audit Report Content. | TR | NA- | 2010-03-01 | -- |
| NBOG BPG 2010-3 | Certificates issued by Notified Bodies with reference to Council Directives 93/42/EEC, 98/79/EC, and 90/385/EEC. | TR | NA- | 2010-03-01 | -- |
| NBOG BPG 2014-1 | Renewal of EC Design-Examination and Type-Examination Certificates: Conformity assessment procedures and general rules | TR | 1 | 2014-11-01 | -- |
| NBOG BPG 2014-2 | Guidance on the Information Required for Notified Body Medical Device Personnel Involved in Conformity Assessment Activities | TR | 1 | 2014-11-01 | -- |
| NBOG BPG 2014-3 | Guidance for manufacturers and Notified Bodies on reporting of Design Changes and Changes of the Quality System | TR | 1 | 2014-11-01 | -- |
| NBOG BPG 2016-1 | (Re-)designation of notified bodies: Process for joint assessments | TR | 1 | 2016-06-01 | -- |
| NBOG CL 2010-1 | Checklist for audit of Notified Body's review of Clinical Data/Clinical Evaluation. | TR | NA- | 2010-03-01 | -- |
