Article 15 in the MDR/IVDR uses generally defined terms but leaves some room for interpretation. Close reading of Article 15 in conjunction with other articles of the regulations can help to gain a better understanding of this role. However, this still leaves some unclear issues, for example, how an outsourced Responsible for Regulatory Compliance (PRRC), should work or what to do when things are not compliant.
Expert presenters at this workshop will lead an interactive discussion on the role of the PRRC, including where they are working with manufacturers or authorized representatives and whether they are outsourced for micro or small sized companies or in-house for larger companies. For each of these roles, scenarios will be presented with examples of challenges faced by PRRCs and how they can be handled. Scenarios will be presented based on different company situations, to explore a range of possible working methods for the PRRC to employ.
This workshop will also examine Article 15 and the connected parts of the MDR/IVDR and relevant guidance documents that may be explicitly and implicitly relevant. The potential impact of the proposed amendments to the MDR/IVDR published by the European Commission in December 2025 will also be addressed, including the latest regulatory updates. The workshop will be interactive, providing plenty of opportunity for attendees to ask questions and share their own experience.
Learning Objectives
Upon completion, participants will be able to:
- Explain the role of the PRRC in general and describe the different challenges facing PRRCs of a manufacturer or authorized representative, in-house or outsourced
- Apply this information in their daily activities
- Prepare measures to take the necessary steps to handle major issues related to the role of the PRRC
- Attain and maintain compliance with the Regulations
- Differentiate the role of the PRRC from other roles they may have within the organization
Who Should Attend?
Regulatory and Quality personnel, staff who are already appointed as PRRC and those who may be thinking about taking up a post as PRRC. Staff employing and/or managing PRRCs.
- Manufacturers of Medical Devices
- Authorized Representatives based in European Union
Audience Learning Level
Intermediate: Content is designed based upon the assumption that individuals have basic knowledge of the topic(s) and/or demonstrated competence related to the topic(s). Higher-level concepts are introduced during lectures; exercises requiring synthesis and/or application of concepts are incorporated into the activity.
Agenda
|
Time |
Topic |
Speaker |
|
9:00 – 10:00 AM |
Overview of Art. 15 requirements and MDCG 2019-7 Tasks of the PRRC |
Elem Ayne |
|
10:00 – 10:15 AM |
Break |
|
|
10:15 – 11:15 AM |
Choosing appropriate practical working methods Using an example scenario, explore types of activities that could be employed, reporting of non-compliances, escalation of serious issues |
Anne Jury |
|
11:15– 11:30 AM |
Break |
|
|
11:30 AM– 12:30 PM |
Differences of working methods employed in different scenarios a) multiple PRRCs employed within a large global organisation b) single PRRC working also as the RAQA Manager c) external PRRC working for a micro company d) PRRC employed within an Authorised Representative with many clients Consequences of non-compliance within an organization |
Anne Jury
and
Elem Ayne |
|
12:30 – 1:00 PM |
Open questions |
|
Cancellations and Refunds
RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation. All cancellation requests must be submitted in writing to [email protected]. Cancellations will receive a full refund minus a 20% administrative fee. RAPS is unable to accept cancellations by phone.
Substitutions
Paid registration substitutions may be accepted with written approval from RAPS for requests received before the start of the event. To transfer a registration, email [email protected] with the event title, name of the original registrant and the contact information for the new attendee.
Proof of Attendance
A certificate of attendance can be downloaded from the RAPS Learning Portal following the event.
Questions
Contact the RAPS Support Center:
Call +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email [email protected].
Speakers
Elem Ayne
Anne Jury
