This seminar will be held in English! Every manufacturer of medical devices must appoint at least one „Responsible Person“ who is familiar with the provisions of the EU MDR and / or IVDR regulations and monitors compliance. Get the necessary knowledge about the areas of responsibility with this seminar!
What are my responsibilities as the person in charge? How do I plan for long-term compliance with these requirements?
In this seminar, in addition to the regulatory framework, you will receive many practical tips and learn how the requirements can best be implemented.
Seminar contents
- Introduction
- General, purpose, regulation, definitions
- Legacy device, transitional provisions
- Person responsible for regulatory compliance
- Qualifications, responsibilities, availability
- Liability
- Technical documentation (Annex II):
- Structure incl. content
- Technical documentation (Annex III):
- Post-Market Surveillance System, Vigilance, Market surveillance
- Conformity assessment (Annex IX, X, XI)
- EU declaration of conformity (Annex IV)
Participants
This seminar is not recommended for participants without prior knowledge. Basic knowledge of the MDR and / or IVDR would be ideal.
The requirements for the role of the responsible person are precisely defined here: https://medizinprodukteregister.at/PRRC
Costs
- Early booking (up to 4 weeks before the seminar): Euro 540,- (excl. VAT)
- Standard (from 4 weeks before the seminar): Euro 610,- (excl. VAT)
- incl. seminar documents as PDF and certificate of participation
- All seminar discounts at a glance
Your trainer
Daniel Rubisoier, BSc, MSc, Conformity Assessment Procedure Specialist MDR, TÜV SÜD Product Service GmbH