15. YOUR STAFF AND PEOPLE IN CHARGE FOR CE

• Organization Chart ( Develop A Diagram)

• Redaction, Recording and Organization of Documentation

• Quality Manual Set Up.

• For all These Operations You Need A Coordinator.

16. WHICH NOTIFIED BODY

• Government derived organization, private body or Ministry of Health. The situation is harmonised but a mutual agreement between them exist

• Depends of product class: Class I non sterile means possible self assessment.

Class I sterile, Class IIA, IIB and III Notified Body with competence for the dedicated products

• Communication, local correspondents, the costs, number of required inspections are of significant importance of the selection of the Notified Body.

17. THE WAY TO CE

• For the time being Quality Systems are specified by EN 29001, EN 46001 or EN 29002 , EN 46002

• Remark: EN/ISO are setting up an update called ISO 2000

Note:

EN46002 and ISO 9002 are in revision into EN-ISO 13488-2000.

EN 46001 and ISO 9001 are in revision into EN-ISO 13485-2000.

18. HOW TO READ THE RECOMMANDATIONS?

• Read carefully

• These documents are applicable for the whole medical industry.

• Carefully follow the way applicable to your company and products.

• You are the expert for your products.

• Learn regulatory affairs vocabulary.

19. QUALITY MANUAL & THE MANAGEMENT INVOLVEMENT

• First Quality Manual set up

• Regular meetings for: Planning-Reporting of attached meetings ( management, products post market survey, development, corrective actions, training of operators, sales force etc.)

• Regular evaluation of suppliers end or subcontractors.

20. PRODUCTS DOCUMENTATION

• Set up for a technical documentation for each product.

• Risk analysis for the intended use

• Directions for use and warnings

• Documented corrective actions

• Sterilisation process if applicable

• Products with measuring function.

21. LABELLING

• Multilingual and with symbols

• Directions for Use and Warnings

• Commercial documents.

22. BIOLOGICAL EVALUATION OF MEDICAL DEVICES

• Raw materials, process, bio-burden and clean room maintenance are monitored in order to meet the EN-ISO 10993-1

• A significant cost of reduction for biological tests can be obtained due to a good reporting of post market survey and risk analysis documented files.

CONCLUSION!!!

THE CE MARKING OF CONFORMITY IS A LIVING QUALITY SYSTEM