Technical Documentation Creation

Technical Documentation for Medical Devices

Introduction

As requested under the previous directives, Technical Documentation must be available and kept up to date for all Medical Devices placed on the market in the EU.

If the manufacturer is located outside the European Union, this documentation must now be available from the European Representative appointed by the manufacturer.

New Requirements

The number of General Safety and Performance Requirements which replace the Essential Requirements has reached 220 points to be reviewed and robust risk management must be put in place and regularly reviewed.
New requirements have arisen, for example with regard to substances Carcinogens, Mutagens, toxic for Reproduction (CMR) and endocrine disruptors.

The information to be provided by the manufacturer in its user manual and on the labels is now very regulated. But as expected, clinical requirements have changed the most.

Whether you have already placed your Medical Devices on the market or this is a first, do not hesitate to contact our team of specialists. We could:

  • Bring your existing Technical Files into conformity with the new regulation (EU) 2017/745
  • Create from scratch your Technical Documentation according to regulation (EU) 2017/745

Contact

Avenue Leonard de Vinci, 14
1300 Wavre, Belgium

+32 2 888 40 10
+44 20 3866 1208

info@biorius.com

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