A technical file is key for a medical devices’ CE marking conformity assessment. The technical documentation, also called technical file or Design Dossier, holds the information of the medical devices’ conformity to the essential requirements of the Medical Devices Directives (MDD, AIMDD, IVDD). Notified bodies and competent authorities use the technical documentation to ensure that the medical device conforms to the applicable regulations, and manufacturers use it as a living reference tool for the device. As a result, ensuring the contents are complete and updated is of utmost importance for a medical device manufacturer to maintain its devices’ CE marking.
For information about the contents of IVD technical file and what Notified Bodies look for in the technical file submissions, IVD manufacturers can tune to LNE/G-MED North America’s upcoming Free webinar on IVD Technical File compilation.
The points covered in the webinar will include:
•The requirements of the European Directive 98/79/EC of 27 October 1998 on IN VITRO DIAGNOSTIC MEDICAL DEVICES (“IVDD”),
•The different parts and documents that go into making a technical file,
•The use of the IVD technical file by Manufacturers, Notified Bodies, and Competent Authorities,
•The unique requirements and challenges of IVD technical documentation.