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