How to get your Medical Device on the EU market as soon as possible and remain in full compliance with the medical device regulation?
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?
You will get insights in what are the key requirements regarding the Technical documentation and the Quality Management System of the device and 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 rule 11
– Annex XIV: devices with no medical purpose.
– COVID -19 examples
Presenter Anja Wiersma, is a medical biologist by training with a PhD in the NeuroPharmacological –Behavioural – Physiology field. After working for 8 years at a multinational Pharmaceutical company (Organon), she started to work for a Notified Body in the field of Medical Devices and In Vitro Diagnostic Medical Devices. She was working for this notified body for 6.5 years.
She is fully qualified as a notified body auditor for all the Medical Device Directive (MDD 93/42/EEC); Medical Device Regulation (MDR EU 2017/745); the In Vitro Diagnostic Device Directive (IVDD 98/79/EC) and In Vitro Diagnostic Device Regulation (IVDR 2017/746).
Since 2010 she is a RA/QA consultant at mi-CE consultancy for medical device and in vitro diagnostic device manufacturers, and she remains a contractor for several notified bodies executing design dossier reviews and CE audits as well as for executing inspections for independent organisations.
Since March 2015 she is member in the board of the RAPS Netherlands Chapter. RAPS is the Regulatory Affairs Professional Society. As of March 2017, she is the chair of the board of the RAPS Netherlands Chapter. And as of September 2017, she is a member of the REC as well (RAPS European Council).
This workshop is powered by Briskr Validate! – a project funded by EFRO (European Fund for Regional Development)