Technical File Compilation

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:

  1. General Requirements
    1. EC declaration of conformity and classification according to ANNEX IX.
    2. Name and address of the manufacturer/European Representative
    3. Product description including
  2. Product specification
  3. Product verification

more details can be obtained from mdi Europa upon request – contact us

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