Do CE product approval

General :
Version:	1.0

Project :
Author:	Wolfgang Kern
Created:	14.03.2014 11:26:13
Modified:	16.09.2019 16:16:07

Diagram Elements :

Prototype

Select representative product sample for audit

Application form product examination

Apply for product certification

Review checklist ETF

EC design-examination certificate

Initial CE approval audit

Notified Body

ETF assessment

RA Specialist

Medical device CE approved

ETF - European Technical File

Create declaration of conformity

Check and declare compliance with ER 98/37/EEC (if applicable)

Check and declare compliance with ER 93/42/EEC

Compile ETF

Declaration of conformity for CE

Essential requirements machine directive 98/37/EEC

Essential requirements medical devices 93/42/EEC

Need for CE approval