Person Responsible for Regulatory Compliance according to MDR and IVDR

This one day course will provide a background on Personal Responsible for Regulatory Compliance duties and how this concept is translated into the Medical Device and IVD world, and will cover some of the practical aspects of the implementation of this new requirement

Outcome
In May 2017, the European Union released the Medical Devices Regulation (MDR 2017/745/EU) to replace the Medical Devices Directive. More than one third of the transition period to May 2020 has passed in the challenging work for medical device organisations to understand and start implementing the numerous changes. The new MDR and also the IVDR introduce the new concept of Personal Responsible for Regulatory Compliance (PRRC).
 
This one day course will provide a background on Personal Responsible for Regulatory Compliance duties and how this concept is translated into the Medical Device and IVD world, and will cover some of the practical aspects of the implementation of this new requirement for manufacturers.
 
“Manufacturers shall have available within their organisation at least one person responsible who possesses expert knowledge in the field of medical devices.” Or: “five years of professional experience in regulatory affairs or in quality management systems relating to medical devices.”

Sign up for this course regarding the ”Role of the Personal Responsible for the Regulatory Compliance” and learn about the concept and how to implement the requirements in your organisation.

Content 

  • Review of requirements
  • Review of the role of person responsible for regulatory compliance for devices, including the personal responsibility associated with documentation review and the skills required to approve devices
  • Tasks associated with the role of person responsible for regulatory compliance:
    • QMS compliance
    • Technical documentation – preparation and maintenance
    • Post Market Surveillance obligations
    • Reporting
  • Personal responsiblity – independence
  • How to implement the new requirements in your organisation 

Who should attend
Manufactures, distributors and importers including:
- Regulatory Managers
- Quality Mangers
- General Management
 
Trainers
Pernille Veje, CEO, Mayday Solution ApS
Søren Lyngsø-Petersen, Senior Consultant, Pharma4ever

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Kontakt

Morten Petersen
Uddannelseskonsulent
49184703