A Technical File is required for all products falling under one of the three medical device Directives, including low risk Class I and custom made devices. mdi Europa will help you to comply with the necessary legislation and assist in ensuring that your Technical File is ready for review by a Notified Body (as and when necessary) or the local Competent Authorities in Europe.
Here is a short overview of the mandatory contents of a Product Master File:
- General Requirements
- EC declaration of conformity and classification according to ANNEX IX.
- Name and address of the manufacturer/European Representative
- Product description including
- Product specification
- Product verification
more details can be obtained from mdi Europa upon request – contact us