Person Responsible for Regulatory Compliance (PRRC) according to MDR Article 15
The EU Regulation on Medical Devices (MDR - (EU) 2017/745) requires in Article 15 that each manufacturer of medical devices as well as each authorized representative has a Person Responsible for Regulatory Compliance (PRRC). This function includes the responsibility for both: the regulatory conformity of devices and the compliance with processes defined in the quality management system, under which the devices are manufactured, before a device is released.
Important: TÜV SÜD tests and certifies through its Notified Bodies medical devices and their manufacturers. TÜV SÜD Akademie GmbH offers trainings in the field of medical devices.
The neutrality and independence of the conformity assessment procedures carried out by TÜV SÜD must be maintained. In the interest of our customers, hence the seminars of TÜV SÜD Akademie do not contain any product-specific, process-related or company-specific content or solutions that could fulfill the function of individual consulting.
In case of any questions or uncertainties, please do not hesitate to contact us at [email protected].
Who Should Attend?
Manufacturers, importers, distributors and EU representatives of medical devices and employees, who will be appointed to this position and their deputy:
- Clinical Affairs Manager
- Consultants
- Managing Director
- Regulatory Affairs Manager
- Quality Management Manager
Course Agenda
- Introduction of MDR
- Person responsible for regulatory compliance (PRRC) according to Article 15 - requirements of the new role
- Documentation on the responsible person – Proof of Competences
- Registration of the responsible person (EUDAMED)
- Tasks: verification of product conformity, TD, vigilance activities and PMS
- Reporting obligations:
- Post-market monitoring (PMS) – plans and required reports
- Reporting of serious incidents and field safety corrective actions
- Reporting of trends and Management review
- Clinical investigations: declaration for test products
- Availability: special provision for micro, small and medium-sized enterprises
- Responsible person& authorized representatives
- Liability and dealing with deviations
- Workshop
Course Description
The PRRC shall be responsible for ensuring that the conformity of the devices is appropriately checked, the technical documentation and the EU declaration of conformity are drawn-up and keep up-to-date, and the post-market surveillance obligations are complied within accordance with Article 10(10), as well as to ensure reporting of serious incidents. After an introduction to the EU legal framework, the necessary requirements for expert knowledge and the duties associated with the new function as PRRC will be presented by the instructor.
Methodology
Instructor-led training in a virtual classroom. This means the course is Live Online. Participants will learn through online teaching. Lectures, case studies, group exercises, discussions, problem solving, examples with explanation, assignments and/or quizzes happen in the virtual classroom training. Participants need to connect to the class from any internet accessible location. Each module is delivered live using webinar technology, creating a virtual classroom learning environment. Live sessions provide you with direct access to the trainer so you can ask questions, understand complex concepts and share ideas with peers. Webcam and microphone are REQUIRED to interact with the instructor and/or other participants.
The course content and structure are designed by the domain experts from TÜV SÜD.
With immense experience and knowledge in the relevant standards, our team of product specialists and technical experts at TÜV SÜD, developed the course content based on current business landscape and market requirements.
This seminar addresses internationally valid standards. It is a single training.
Learning Assessments
TÜV SÜD Academy certificate of attendance