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Workshop MDR for medical devices
13 oktober @ 14:00 - 16:00
How to get your Medical Device on the EU market as soon as possible and remain in full compliance with the new medical device regulation (MDR)?
This workshop will start with a basic presentation on the most important topics of the new Regulation. This provides insight in the new MDR requirements including timelines when to comply and how to comply to these requirements. The need of a Notified Body involvement is discussed and which one do you need to pick? And do they have time for your company?
The approach of the workshop is to have an interactive lively discussion with the attendance using practical examples. The attendance will leave with knowledge on the practical implementation of the MDR requirements. Some examples of the topics are:
– Regulatory strategy planning
– General Safety and Performance Requirements
– Clinical evaluation and evidence including clinical trials needed
– Post Market Surveillance plan, PSURs, PMCF
– Risk Management
– Labelling, IFU,
– UDI/ Eudamed
– Economic operators’ control
– Person Responsible for Regulatory compliance (PRRC)
– Up classification of device: Medical Device Apps à rule 11
– Annex XIV: devices with no medical purpose.
– COVID -19 examples
This workshop is powered by Briskr Validate! – a project funded by EFRO (European Fund for Regional Development)