最新欧盟医疗器械法规目录.docx

Guidance MEDDEVsThe guidelines aim at promoting a common approach by manufacturers and Notified Bodies involved in the conformity assessment procedures according to the relevant annexes of the Directives, and by the Competent Authorities charged with safeguarding Public Health.They have been carefully drafted through a process of consultation with various interested parties during which intermediate drafts were circulated and comments were taken up in the documents. Therefore, they reflect positions taken in particular by representatives ofCompetent Authoritiesand Commission Services, Notified Bodies, industry andother interested partiesin the medical devices sector.The guidelines are not legally binding. It is recognised that under given circumstances, for example, as a result of scientific developments, an alternative approach may be possible or appropriate to comply with the legal requirements.Due to the participation of the aforementioned interested parties and of experts from Competent Authorities, it is anticipated that the guidelines will be followed within the Member States and, therefore, ensure uniform application of relevant Directive provisions. Guidelines are subject of a regular updating process.Disclaimer: Please note that the amendments introduced by Directive 2007/47/EC or previous amending directives have not yet been incorporated in all MEDDEVs. The necessary revision is under way.TITLE2.1Scope, field of application, definitionMEDDEV 2.1/1(19 KB)Definitions of medical devices, accessory and manufacturerApril 1994MEDDEV 2.1/2 rev.2(14 KB)Field of application of directive active implantable medical devicesApril 1994MEDDEV 2.1/2.1(12 KB)Field of application of directive active implantable medical devicesFebruary 1998MEDDEV 2.1/3 rev.3(182 KB)Borderline products, drug-delivery products and medical devices incorporating,as integral part, an ancillary medicinal substance or an ancillary human blood derivativeDecember 2009MEDDEV 2.1/4(21 KB)Interface with other directives - Medical devices/directive89/336/EEC relating to electromagnetic compatibility and directive 89/686/EEC relating to personal protective equipmentMarch 1994For the relation between the MDD and directive 89/686/EEC concerning personal protectiveequipment, please see the Commission servicesinterpretative document of 21 August 2009(32 KB)MEDDEV 2.1/5(10 KB)Medical devices with a measuring functionJune 1998MEDDEV 2.1/6(323 KB)Qualification and Classification of stand alone softwareJanuary 20122.2Essential requirementsMEDDEV 2.2/1 rev.1(16 KB)EMC requirementsFebruary 1998MEDDEV 2.2/3 rev.3(17 KB)Use by - dateJune 1998MEDDEV 2.2/4(39 KB)Conformity assessment of In Vitro Fertilisation (IVF) and Assisted Reproduction Technologies (ART) productsJanuary 20122.4Classification of MDMEDDEV 2.4/1 rev.9(654 KB)Classification of medical devicesJune 20102.5Conformity assessment procedureGeneral rulesQuality assurance.Regulatory auditing of quality systems of medical device manufacturers(See document in the GHTF-Global Harmonization Task Force)MEDDEV 2.5/3 rev.2(9 KB)Subcontracting quality systems relatedJune 1998MEDDEV 2.5/5 rev.3(7 KB)Translation procedureFebruary 1998MEDDEV 2.5/6 rev.1(10 KB)Homogenous batches (verification of manufacturers products)February 1998Conformity assessment for particular groups of productsMEDDEV 2.5/7 rev.1(93 KB)Conformity assessment of breast implantsJuly 1998Evaluation of medical devices incorporating products of animal origin.(SeeMEDDEV 2.11/1 rev.2(82 KB)MEDDEV 2.5/9 rev.1(97 KB)Evaluation of medical devices incorporating products containing natural rubber latexFebruary 2004MEDDEV 2.5/10(78 KB)Guideline for Authorised RepresentativesJanuary 20122.7Clinical investigation, clinical evaluationMEDDEV 2.7/1 rev.3(378 KB)Clinical evaluation: Guide for manufacturers and notified bodiesDecember 2009Appendix 1: Clinical evaluation on coronary stents(101 KB)December 2008MEDDEV 2.7/2(37 KB)Guide for Competent Authorities in making an assessment of clinical investigation notificationDecember 2008MEDDEV 2.7/3(166 KB)Clinical investigations: serious adverse event reporting-SAE reporting form(87 KB)December 2010MEDDEV 2.7/4(180 KB)Guidelines on Clinical investigations: a guide for manufacturers and notified bodiesDecember 20102.10Notified bodiesMEDDEV 2.10/2 rev.1(105 KB)Designation and monitoring of Notified Bodies within the framework of EC Directives on Medical devicesAnnex 1(120 KB),Annex 2(14 KB),Annex 3(17 KB),Annex 4(26 KB)April 20012.12Market surveillanceMEDDEV 2.12/1 rev.8(745 KB)Medical Devices Vigilance SystemJanuary 2013Manufacturer Incident Report(971 KB)How to use the MIR(13 KB)Field Safety Corrective Action(2 MB)Trend Report(151 KB)Periodic Summary Report(192 KB)MIR and FSCA xml files(2 MB)List of contact pointsMEDDEV 2.12/2rev.2(221 KB)Post Market Clinical Follow-up studiesJanuary 20122.13Transitional periodMEDDEV 2.13 rev.1(13 KB)Commission communication on the application of transitional provision of Directive 93/42/EEC relating to medical devices (OJ 98/C 242/05)August 1998As regards the transitional regime of Directive 2007/47/EC see theInterpretative Document of the Commissions services of 5 June 2009(36 KB)2.14IVDMEDDEV 2.14/1 rev.2(75 KB)Borderline and Classification issues. A guide for manufacturers and notified bodiesJanuary 2012MEDDEV 2.14/2 rev.1(64 KB)Research Use Only productsFebruary 2004MEDDEV 2.14/3 rev.1(80 KB)Supply of Instructions For Use (IFU) and other information for In-vitro Diagnostic (IVD)Medical DevicesJanuary 2007Form for the registration of manufacturers and devices In Vitro Diagnostic Medical DeviceDirective, Article 10(213 KB)Ja