European Medical Device Regulation (EU-MDR)

The new EU-MDR brings about many changes, including many definitions, reclassifications, new conformity assessment routes, new Notified Body designations and more. Stricter requirements on the safety of ingredients, on clinical evidence and on consistency in regulatory compliance. Much more detailing in the essential principles, and above all: no grandfathering!

Training Courses:

Fundaments of the European Medical Device Regulation 

Do you need to know more than the basics of the MDR? Take the 2-day course as there are a lot of changes. Build a solid foundation to ensure compliance.

MDR - Transition

Understand the regulatory impact of remediation, retire, and transition of your product portfolio (portfolio rationalization). Transition timelines and strategy options.

MDR/IVDR - Executive course

This course is provided in-house and geared towards executive management of MedTech companies.

MDR - PMS/PMCF

Learn in a practical way to look at PMS, understand the options for compliance.

MDR - Economic Operator/ Supply Chain

How to establish, monitor and maintain the mutual agreements of manufacturers with the other economic operators (including Authorized Representative and importer) and suppliers/ subcontractors.

MDR - Clinical Investigation


How to deal with clinical requirements in the MDR. The start point is your current intended use. What do you claim, or want to claim, how is this related to risk management, and how do you know if your current data is sufficient?

MDR/IVDR - How to write a technical file

This training focusses on practical guidance to fulfill the technical documentation requirements in the EU-MDR 

 

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