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Course Overview
The Person Responsible for Regulatory Compliance (PRRC) role was created under article 15 of the Medical Device Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR). However, the exact details of the role such as qualifications required, tasks, liability and administrative elements have been unclear for many.
Led by Anne Jury of Team-PRRC, this course will provide you with clarity on the role and all its responsibilities, so your organisation is compliant. You will examine key topics such as qualifications, appointment, registration, tasks, compliance and admin. It is designed for professionals who are a PRRC or considering becoming a PRRC for their organisation. It is also beneficial for management to attend so they fully understand the role of the PRRC.
Key Learning Objectives
Review the regulation and understand why the role was set up as part of the MDR
Examine the qualifications required to be a PRRC and how to document this
Discuss the important elements of appointing a PRRC such as having an agreement / job description
Registration of the PRRC under Eudamed
Review the responsibilities of a PRRC of a manufacturer and Authorised Representative and analyse the tasks needed to perform these responsibilities
Discuss the liability of the PRRC – what does this mean for me?
In groups examine real-life scenarios to fully cement the course learnings
What is Included?
Direct access to an expert trainer
Interactive and engaging sessions
Access to the Educo Life Sciences Training Portal
Unlimited access to the recordings for 2 weeks after the session
Download the Agenda
You can view the agenda below or if you would like to receive a pdf version with all the course information, please complete the form below.
Learn more about the course by toggling through the tabs below (trainer, venue, who should attend?)
The course begins at the time stated at the top of the page
The course is broken up into modules outlined below
There will be breaks between modules
Session 1
26 April 2023 | 180 mins | 9:30 AM UK
Introductory overview of MDR 2017/745
Context of the Person Responsible for Regulatory Compliance (PRRC) according to Article 15 MDR / IVDR and associated recitals
Comparison with similar roles in other regulations / History of PRRC
Qualifications for the PRRC
Required qualifications
Documentation on the responsible person – proof of qualification and competences
Appointment of PRRC
Job description – scope / duties
Importance of agreement / contract
Location of PRRC
Registration of the responsible person
Eudamed – where and what to register
Practical implications for PRRC
Tasks of the PRRC
For PRRC of a manufacturer
Verification of product conformity, technical documentation, vigilance activities, post-marketing surveillance (PMS), compliance of investigational or performance evaluation devices with Annex I
For PRRC of an authorised representative (AR)
Ensuring compliance with the mandate between AR and Manufacturer
Session 2
26 April 2023 | 180 mins | 1:30 PM UK
Choosing the appropriate practical working methods to demonstrate compliance
Reports
Audits
Spot checks
Review and approval of relevant procedures/ forms / documents
Inclusion of PRRC responsibilities within the QMS
Administrative considerations
Availability
Liability
Implications of the special provision for micro, small and medium-sized enterprises I.e. dealing with the external PRRC
Aptitudes required for successful PRRCs
Ensuring the PRRC has the organisational freedom to operate effectively (from both employer and PRRC perspective)
Interdepartmental and interpersonal communication requirements
Dealing with difficult situations
Workshop
Work through a real-life scenario, tasks required, methods to use, consequent actions and results.
Anne Jury is a consultant and trainer in medical devices EU & UK regulatory compliance and quality assurance systems. Starting out as company microbiologist for Smith & Nephew Textiles Anne went on to work for Notified Bodies, BSI and then TÜV Product Service as a lead auditor and later as UK Regional Manager.
Anne has run her own consultancy business since 2000 providing medical device regulatory support to companies ranging from research institutes and start-up companies to SMEs and multi-national market leaders. Anne was one of the founders and visiting lecturers to the MSc in Medical Technology Regulatory Affairs run by TOPRA and Cranfield University where she was also external examiner from 2009 to 2012.
Anne has extensive MDR expertise, supporting her clients transition from the MDD as new guidelines and ISO standards are published. As a result, she can draw on multiple case study examples and experience when delivering MDR training courses. Anne has led both in-house and public courses on medical device EU regulatory affairs for several years.
Anne is also Vice-President of Team-PRRC, a non-profit organization set up in March 2020 to support individuals in the role of PRRC under the EU medical device regulations.
This course is designed for professionals who are currently a PRRC or looking to take on the responsibility of PRRC in the Medical Device and IVD industry. It also applicable to senior management who would like to get to grips with the role.
Could your team benefit from this course?
We can customise this course to meet the requirements of your organisation, delivered as a classroom and/or online course.
For more information you can email us at [email protected] or call +44 (0) 203 111 7357.
Or please summarise your objectives by following the link. Get in touch.
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• This course is delivered online
• For live online courses, module durations are approximate
• You will have full access to the training portal and the recordings for 2 weeks after the training
