EU MDR 2017/745 AND IVDR 2017/746 PERSON RESPONSIBLE FOR REGULATORY COMPLIANCE TRAINING – upon request
(To calculate the correct time zone, please feel free to use the button “Time zone converter” and use Berlin as a reference European Time)
The Person Responsible for Regulatory Compliance (PRRC) is a new and critical role under the MDR and IVDR. As this is a new expectation of the incoming regulations, many manufacturers have questions regarding what the requirements are applying to their organization. PRRCs under the new regulations will have responsibilities regarding the Declaration of Conformity (DOC), technical documentation, post-market surveillance (PMS) and reporting (vigilance, serious incidents, trend reporting and field safety corrective actions (FSCA)) as well as clinical investigations. In this training session, you will gain a detailed understanding of the requirements under Article 15 for the responsibilities of a PRRC, expectations of MDCG 2019-7 and have confidence in your strategy to fulfil the new requirements.
• Opening remarks
• Introduction to EU MDR / IVDR
• Responsibilities of PRRC under EU MDR and IVDR and examples of involvement in organization
• Requirements and considerations for manufacturers and assignment of a PRRC
• MDCG 2019-7 Guidance on Article 15
• Q&A session
• Closing remarks
- Start 02:00 PM – End 06:00 PM. Attendees are recommended to login 15 min in advance.
In order to keep the training interactive, the exact content schedule cannot be provided.
Certification:Personal Certificate will be provided in PDF
Presentation:Presentation will be provided in PDF