MDR 2017/745 and IVDR 2017/746 require in Article 15 that all manufacturers appoint a "person responsible for regulatory compliance" from 26.05.2021 (MDR) and 26.05.2022 (IVDR) respectively. This person is also called:
The PRRC replaces the Medical Device Safety Officer - which is currently only required by German and Austrian law (Medical device act). However, the tasks and area of responsibility of the PRRC go far beyond those of the Safety Officer. The PRRC is now required for all manufacturers of medical devices who CE mark their devices, so not only if you are located in Europe, but worldwide. The PRRC is - similar to the Qualified Person in the pharmaceutical industry- personally responsible for the conformity of the shipped medical devices, from development to production and release.
In this training you will learn in detail about:
This seminar constitutes the basis for becoming a PRRC. We recommend further seminars in order to be able to cover the extensive area of responsibility:
|09:00||Beginning of the seminar|
|09:00||Opening, introduction round, expectations|
Legal basics: MDR Article 15, expertise Tasks of the PRRC:
Tasks of the PRRC:
Tasks of the PRRC:
|16:00||Questions (you haven’t asked yet)|
We limit the maximum number of participants to 16 to ensure learning success and having enough time to respond to individual questions.
Alexander Thern is lead auditor for MDD 93/42, ISO 13485, MDSAP and MDR. For the Johner Institute he is the trainer for "Internal Auditor" and "Medical Device Consultant and Safety Officer" since many years. He shares the common vision of lean QM systems that contribute to real quality improvement and more cost-effective development and production. Alexander Thern looks back on many years of consulting and auditing practice. He has been working for the Johner Institute since 2010. Alexander has lived in England and speaks fluent (British) English
The seminar "PRRC" is mainly aimed at the following roles:
Experience as a safety officer is helpful, but not a prerequisite.
Currently our registration process is still in German, so in case of any questions or difficulties please contact our Seminar team directly.