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


Close
 
 
x
Diese Seite verwendet Cookies, um Ihnen das bestmögliche Nutzererlebnis zu bieten. Wenn Sie auf der Seite weitersurfen, stimmen Sie den Datenschutzbestimmungen zu. Bitte lesen Sie unsere Datenschutzbestimmungen für weitere Informationen. Das ist gut