MedicalMountains GmbH Person responsible for regulatory provisions according to Article 15 EU MDR

Content

The following topic areas will be covered within the seminar:

• Regulatory principles from the EU MDR to PRRC
• Designing the role of the Regulatory Responsible Person (PRRC)
• Tools of the trade for the PRRC

In the first two subject areas, the focus is on the following topics:

• Analysis and evaluation of relevant sections from the EU MDR
• Rights & Responsibilities of the PRRC
• Refresh of key regulatory requirements and structures, including Basic Safety and Performance Requirements (GSLA), EU Declaration of Conformity, Technical Documentation, Product Registration (EUDAMED/Basic UDI-DI/UDI)
• Description of the obligations of the manufacturer and the notified bodies
• Design of the PRRC in the company: Interfaces of the PRRC, PRRC in the context of the process landscape in the company

The topic area of hand tools for the PRRC is about teaching the following topics:

• Communication with notified bodies and relevant authorities
• Monitoring regulatory requirements

Topic overview

• Design of the PRRC according to EU MDR in the company
• Regulatory basis for the PRRC, including:
  • Obligations of manufacturers/obligations of notified bodies
  • GSLA/EU declaration of conformity
  • Product registration
• Communication with notified bodies and relevant authorities
• Change management/reporting and action/monitoring of regulatory requirements

target group

People who act or will act in the future as PRRCs in the company.

Prior knowledge

General previous knowledge in the field of medical devices.

Funding opportunity

ESF funding is possible. Further information can be viewed here .

Early bird discount

If you register up to 3 weeks before the start of the seminar, you will receive an early bird discount of 10 percent.

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