The Person Responsible for Regulatory Compliance - The MDR and new responsibilities and challenges for medical device companies

Since the publication of the MDR with the new EU regulatory framework for medical devices, many innovations need to be  implemented. One of them is the person responsible for regulatory compliance (PRRC).

This 'responsible person' has important tasks and responsibilities, which, together with liability risk, will be discussed in detail in this seminar. How must the responsibilities be defined? What are the internal interfaces? What preparation is required for this new role?
Our seminar will address precisely these questions and show you how to make the necessary preparations. Our team of  experts will give you practical tips on how to meet the upcoming challenges and explain the most important issues in practice.

PARTICULAR TOPICS INCLUDE

• Legal and regulatory requirements for the PRRC in Europe

• Interfaces within the company

• Effective preparation and practical challenges

• Audit and compliance readiness

• Liability risk for the PRRC and manufacturer