Technical File


The manufacturer must establish the SAFETY, PERFORMANCE & EFFICIENCY of the medical device via technical documentation also called a technical file or a device master file.

This is applicable for all risk classes of Medical Devices (I, Is, Im, IIa, IIb, III) and the manufacturer must keep up-to-date technical documentation, also called a technical file or a device master file. This documentation demonstrates compliance with essential requirements (Annex I of the 93/42/EEC).

What are the challenges faced during the technical File review by Notified Body?

  • Langage and English grammer
  • Electronic File Format and document numbering and Identification
  • Documents signatures and mismatching dates
  • Searchable PDF file mismatch
  • Technical Documentation not details and not informative
  • Technical File Sections are not inline with common referred STED GHTF Document SG1/N063
  • DOC not detailed and not made as per regulation
  • The followed old version of Harmonized standards
  • No followed the updated CER rev 4

In order to facilitate faster reviews, the following is suggested:

  • Appoint EUROPECERT as your technical partner
  • Outsource the technical File and Clnical evaluation documentation

Frequently Asked Questions

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