ccedil;in- Medical Devices Directive 93 42 EEC updated July 2016.ppt

CONFORMITY ASSESSMENT PROCEDURES Annex VII - Declaration Annex II - Full QA inc. design Annex V - Production QA Annex VI - Inspection QA/QC ------------------------------------- Annex III - Type testing Annex IV - Product verification Annex VIII - Statement Article 11 Class I NO YES Class IIa CE Marking Annex II Audit by Notified Body ( ISO 13485 ) CE Marking Annex V Audit by Notified Body ( ISO 13485 ) CE Marking Annex VI Audit by Notified Body ( ISO 13485 ) CE Marking Annex IV Product Verification by Notified Body Annex VII Declaration of Conformity Device Class IIb CE Marking Annex II Audit by Notified Body ( ISO 13483 ) CE Marking Annex V Audit by Notified Body ( ISO 13485 ) CE Marking Annex VI Audit by Notified Body ( ISO 13485 ) CE Marking Annex IV Product Verification by Notified Body Annex III Type Examination by Notified Body Device Class III EC Declaration Conformity Ensure Application of approved conformity procedures /surveillance Written declaration that device meets provisions of directive Affix ‘CE’ marking Article 11 17 Generally SEE SPECIFIC ANNEXES Classification of Medical Devices 93/42/EEC Classification Based upon terms related to Duration of Contact with patient Degree of Invasiveness Anatomy affected by use Annex IX Ensure first that the product is legally a device, or an accessory, and comes within 93/42/EEC Classification I. Definitions II. Implementing Rules III. Classification Rules Annex IX Classification Duration Invasive Re-useable Active Active Therapeutic Active Diagnosis Central Circulatory Central Nervous Definitions: Classification Rules governed by ‘intended purpose’ Apply separately to each device / accessory Software driving device is in same class Most critical specified location of use Strictest rules highest class applies Implementing Rules: Classification Non- Invasive Invasive Active Special Rules - Rules 1 - 4 - Rules 5 - 8 - Rules 9 - 12 - Rules 13 - 18 Classification Rule