Introduzione
The Periodic Safety Update Report (PSUR) is an entirely new type of report that has been introduced in Article 86 of the Medical Device Regulation (MDR).
It requires manufacturer of class IIa, class IIb and class III devices to prepare a Periodic Safety Update Report (PSUR) for each device and where relevant for each category or group of devices summarizing the results and conclusions of the analyses of the PMS data gathered.
The regulatory requirement is set, yet the PSUR is a new document and manufacturers often do not have a clear view of what it entails:
- What do MDCG guidelines say?
- What are the expected data sources that need to be analysed and presented?
- Which type of preventive and corrective actions need to be listed in the PSUR?
- What are the main findings that should come out of the PSUR?
- Where does it fit within the PMS context and other post-market documents such as the PMCF Evaluation Report, the CER and the SSCP?
This workshop will provide relevant information to draft a PSUR, including what data should be presented and how it should be reported. It will offer the experience of an industry-expert for all representatives involved in working with medical devices under the MDR umbrella.
- The regulation, the guidelines and their context
- Submission obligations and timelines
- Data to be presented and how it should be presented
- Reportable data and main findings
- Challenges and lessons learned from first experiences
The course is addressed to:
• Clinical Affairs
• Post-Market Surveillance
• Regulatory Affairs
• Medical Writers
• Product Managers
• CROs
Interactive training
Docente/i
Markus Pöttker
Markus holds the position of Director of Global Post-Market Surveillance, overseeing global PMS teams for the Orthopaedics, Sports Medicine and Advanced Wound Management business units at Smith+Nephew, a leading global medical technology company. In his previous role within the EU MDR Project team, Markus led the Post-Market Surveillance work stream. In this capacity, Markus ensured the accurate interpretation and implementation of EU MDR requirements throughout the organization.
With a background in law specializing in information law, Markus is deeply passionate about data. He endeavours to transition from traditional document-centric work to more data-driven methodologies. Markus is a founding member of MDKU e.V. and currently serves as the co-chair of MedTech Europe’s PMS & Vigilance Working Group. Additionally, he contributes his expertise as a member of the MDCG Task Forces for Vigilance, PSUR, and PMS, showcasing his dedication to advancing post-market surveillance in the medical technology sector.
Online Training – 2 modules
Module 1 | 01 April 2025 from 09:30 am to 12:30 pm CEST
Module 2 | 02 April 2025 from 09:30 am to 1:00 pm CEST
The course admits maximum 12 attendees
After the registration, you will receive all details about the connection.
The course will proceed with a minimum number of participants. Should this number not be reached the registered participants will be notified one week prior to the commencement of the course.
Early Bird: € 690,00* (until 11 March 2025)
Ordinary: € 875,00*
Freelance – Academy – Public Administration**: € 495,00*
* for Italian companies: +22% VAT
** Early Bird discount not applicable to Freelance – Academy – Public Administration fee
The fee includes: tuition, organizational office assistance, teaching materials and attendance certificate that will be sent after the training via e-mail.
Registrati
Versione Stampabile
Cosa saprai fare dopo il corso
Online interactive training on Zoom platform.
LS Academy will provide the access link to the virtual platform a few days before the training.