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technical documentation
For the registration or approval of your medical device in the various target markets and therefore for its marketing the existence of a Technical Documentation of your medical device is a pre-requisite. Depending on the target market and its regulatory requirements the Technical Documentation is assessed by the responsible Competent Authority or a Notified Body.
Depending on the complexity of your medical device the content of the respective Technical Documentation varies; the type of medical device, its composition as well as the risk classification play a significant role.
In any case the EU Regulations on medical devices require the following documentation of your medical device:
- development documentation
- documentation of production and quality control processes
- documentation of quality control results
In May 2017 the EU Regulations for Medical Devices (MDR, IVDR) entered into force; these will apply after a transition time of 3 years (MDR) and 5 years (IVDR) in 2020 and 2022, respectively. These new regulations enter into force immediately after its publication in the Official Journal of the European Community in all member states and – unlikely to the EU directives – do not need to be translated into national law.
The EU Regulations require besides the development, production and quality control documentation
- technical documentation of Post-Market Surveillance
- documentation of Clinical Performance Studies
- documentation of Post-Market Clinical Follouw-up Studies
If your medical device is an electronical or electromechanical instrument you probably may take into consideration other directives like the Low Voltage Directive (LVD), the Machine Directive (MD), the Electromagnetic Compatibility (EMC) or the RoHS II Directive and the documentation of the corresponding Essential Requirements.
Gladly I support you with the preparation and review of the various Technical Documentations of your medical device.
medlaQ - Consulting for medical devices
Dr. Bernhard Gerstenecker
GENERAL INFORMATION
ADDRESS
medlaQ
Dr. Bernhard Gerstenecker
Scheffelstraße 9
78315 Radolfzell
Tel.: +49 172 3792283