9. DRAW UP A TECHNICAL CONSTRUCTION FILE

All the information concerning to the product and measures that are taken to meet the essential requirements of the directives, is gathered in the Technical Construction File or Product Master File. 

In the file must be indicated what procedures are followed to avoid or to minimise the possible risks associated with the product.

The documentation also includes design, technical outline drawing, test reports, certificates, ( your own and from your suppliers of spare parts or components) user’s manual, reports of meetings, hand-written notes, video tapes, photographs, etc.

In general the documentation must be available until 10 years after the manufacture of the last product to the national government of the country in which the product is placed on the market.

10. AFFIXING THE CE- MARKING

If all the above mentioned steps have been taken, the CE marking can be affixed to each product according the prescribed model.

However the CE-Marking may not be affixed to all products that fall under the scope op a New Approach directive.

There are a number of exceptions, such as spare parts of equipment that are intended to make a complete machine or apparatus.

It is vital that the European legislation be consulted to determine whether or not the CE-marking and possibly other information should affixed to the product.

When a Notified Body has been involved in the approval of the product then the identification mark of this body should probably be added close to the CE-marking.

In many cases also the year in which the product was CE market must be stated.

11. ADAPTATIONS AND NEW DEVELOPMENTS

Any changes to the original product that could influence the risk factor as set out in the directives, could make it necessary to repeat the previous procedures completely or in parts.

Note that all information concerning the modifications also must be included in the Technical Construction File or Product Master File.

12. WHAT INFORMATION DO WE NEED MORE?

• USA (FDA) and Japan will meet up in the future with Europe in a global harmonisation.

Directives for Medical Devices

• Official journal of the European communities

• ISO & EN standards

• ISO 10993 ( FDA / EN)

• CEN / CENELEC conformity with essential requirements.

13. DEFINITIONS OF A MEDICAL DEVICE

• Drugs, devices, Human origin products

• Use is giving you the answer

14. YOUR COMPANY AND THE QUALITY

• Look at the existing standards in your company

• Do you have a QA manual or a system of quality registration?

• Rapid evaluation of the situation in the companies of attendants.