Seminar PRRC - Person Responsible for Regulatory Compliance

MDR 2017/745 and IVDR 2017/746 require in Article 15 that all manufacturers appoint a "person responsible for regulatory compliance" from 26.05.2020 (MDR) and 26.05.2022 (IVDR) respectively. This person is also called:

  •     "Für Regulierungsfragen verantwortliche Person" (German)
  •     PRRC (Person responsible for regulatory compliance)
  •     "Qualified Person" (like in pharmaceutical industry)

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.

Learning objectives

In this training you will learn in detail about:

  •     The tasks and responsibilities of the PRRC
  •     A detailed presentation, analysis, and interpretation of Article 15 MDR / IVDR
  •     The required expertise of the PRRC
  •     The advantages / disadvantages of joint responsibility
  •     The advantages / disadvantages of an internal or external PRRC 
  •     The effects on the organization and the quality system
  •     Best practices for implementation e.g. job description
  •     The possibility of delegating tasks
  •     How to deal with conflicts

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:

  •     Seminar on the basics of MDR / Seminar on the basics of IVDR
  •     Seminar on ISO 13485

 

Target audience

The seminar "PRRC" is mainly aimed at the following roles:

  •     Safety Officer for Medical Devices (what does "promotion" to PRRC mean to me?)
  •     Managing Director (how do you deal with the fact that your PRRC can block the release of your products?)
  •     Quality Manager (who is the responsible in the end?)
  •     Development Manager (what about your responsibility for the conformity of technical documentation?)
  •     Regulatory Affairs Manager

Experience as a safety officer is helpful, but not a prerequisite.

Here you will find information on the next dates and how to register. If nothing to the contrary is noted in the table on the overview page, there are still free places

Contents and Program Schedule

Time Topic
09:00
Beginning of the seminar
09:00 Opening, introduction round, expectations
09:30 Legal basics: MDR Article 15, expertise
Tasks of the PRRC:
  • Conformity of the technical documentation
10:30
Break
10:45 Tasks of the PRRC:
  • Conformity of the technical documentation
  • Post-market surveillance
12:30
Lunch
13:30 Tasks of the PRRC:
  • Reporting of serious incidents and recalls (FSCA, field safety corrective action)
  • Definition of trends and reporting of trends
  • Statement in case of investigational devices
Best practices
  • Job description
15:00
Break
15:15
  • Joint responsibility among several people
  • Advantages/disadvantages - Internal/external PRRC
  • Liability of the PRRC (internal and external liability)
  • Insurance of PRRC
  • Comparison with pharmaceutical industry
  • Penalties and fines (MPDG)- Future German Medical Device Act
  • Conflict management
16:30 Questions (you haven’t asked yet)
17:00
Official ending

We limit the maximum number of participants to 16 to ensure learning success and having enough time to respond to individual questions.

The trainer

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

Currently our registration process is still in German, so in case of any questions or difficulties please contact our Seminar team directly.