The technical documentation, which is also called „medical device file“, „device master file“ or „CE file“, serves the manufacturer in the sense of the MDR as proof that the medical device fulfils the essential safety and performance requirements according to Annex I of the EU Medical Devices Regulation (MDR). This is the prerequisite for the manufacturer to be able to issue a declaration of conformity for the product in question. This file must be kept up to date throughout the entire product life cycle.
When preparing a CE-documentation, BEO BERLIN creates a document structure in accordance with EU MDR 2017/745. This includes the following points, among others:
- Product description and specification
- Classification protocol
- Selection of a suitable conformity assessment procedure
- General Safety and Performance Requirements
- risk-benefit analysis and risk management file
BEO BERLIN prepares or updates your complete CE documentation or consult you on independent implementation.
