Product Training; Requirements Of The Aimdd Directive (90/385/Eec) | Ce Mark; Medical Devices Consultants - MIETHKE M.scio Mode D'emploi

GB | INSTRUCTIONS FOR USE
M.scio

PRODUCT TRAINING

Appropriate product training prior to using
the product is recommended. Please con-
tact Christoph Miethke GmbH & Co. KG for
information about product training. Use the
product only as specified in these instructions
for use.
REQUIREMENTS OF THE AIMDD
DIRECTIVE (90/385/EEC) | CE MARK
The Medical Device Directive requires the
comprehensive documentation of the where-
abouts of medical devices used in humans.
The individual ID of the implants should there-
fore be recorded in the patient's medical
records and patient data card to ensure com-
plete traceability. Approval for marking with
the CE mark for active implantable medical
devices (in accordance with Directive 90/385/
EEC) was initially granted in 2011.
Translations of these instructions for use
into additional languages can be found
on our website (https://www.miethke.com/en/
products/downloads/).

MEDICAL DEVICES CONSULTANTS

In compliance with European directive
on medical devices (directive 93/42/EEC),
Christoph Miethke GmbH & Co. KG has nom-
inated medical product consultants as con-
tacts for all product-related questions.
You can reach our medical devices
consultants at:
Phone +49 331 62083-0
info@miethke.com
12