NIST GCR 01-815
A Guide to the EU Medical Device Directive

VII. Technical File

The manufacturer must compile a Technical File (See NIST SP 951 A Guide to EU Standards and Conformity Assessment, Page 24). This file contains all the relevant information that is needed to demonstrate that the product meets the essential health and safety requirements of the Medical Device Directive.

The manufacturer must prepare the technical documentation described in Annex VII.

The manufacturer or his Authorized Representative must make this documentation, including the Declaration Of Conformity, available to the surveillance authorities (See NIST SP 951 A Guide to EU Standards and Conformity Assessment, Page 33) for inspection purposes for a period ending at least five years after the last product has been manufactured.

Where neither the manufacturer nor his Authorized Representative are established in the Community, the obligation to keep the technical documentation available must fall to the person(s) who place(s) the product on the Community market.

The technical documentation must include:

• a general description of the product, including any variants planned;
• design drawings, methods of manufacture envisaged and diagrams of components, sub-assemblies, circuits, etc.;
• the descriptions and explanations necessary to understand the above-mentioned drawings and diagrams and the operations of the product;
• the results of the risk analysis and a list of the standards applied in full or in part, and descriptions of the solutions adopted to meet the essential requirements of the Directive if Harmonized Medical Device Standards* have not been applied in full;
• in the case of products placed on the market in a sterile condition, description of the methods used; and
• the results of the design calculations and of the inspections carried out, etc.; if the device is connected to other device(s) to operate as intended, proof must be provided that it conforms to the essential requirements when connected to any such device(s) having the characteristics specified by the manufacturer;
• the test reports and, where appropriate, clinical data in accordance with Annex X; and
• the label and instructions for use.

VIII. Vigilance system

The manufacturer must institute and keep up to date a systematic procedure to review experience gained from devices in the post-production phase and to implement appropriate means to apply any necessary corrective actions (See Annex VII of the Directive).

* PDF file format requires the FREE ADOBE ACROBAT READER Software.

If you are unable to use the ADOBE ACROBAT READER Software and require a copy of a PDF document, please request a copy to be sent to you from maureen.breitenberg@nist.gov

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