Day 1 : October 23, 2025
- AUTHORITIES EXPECTATIONS FROM A PRRC
(Alessandra BASILISCO – Servizio Sanitario Nazionale, Ministry of Health)
- DISCUSSION WITH STAKEHOLDERS
* State of Play of EU MDR & EU IVDR
* Overview about the potential future legislative changes and their potential impact on the role of the PRRC
(Alessandra BASILISCO – Servizio Sanitario Nazionale, Ministry of Health;
Giulia MAGRI – Quality & Regulatory Affairs Director, Confindustria Dispositivi Medici;
Merlin RIETSCHEL – Senior Manager, MedTech Europe ;
Christina ZIEGENBERG – Deputy Managing Director, BVMed)
- EUDAMED: updates
(Richard HOULIHAN – Founder, EirMed )
- LIABILITY
* An example of a concrete case
(Erik VOLLEBREGT – Partners, Axon Lawyers; Alex DENOON – Partner, Bristows Law Firm)
Day 2 : October 24, 2025
- ROUND TABLE WITH PRRCs
* Feedback from daily activities, their feeling in the position
(Silvia ZANCOLA, PRRC from a MF (Theras Lifetech) ; Lyudmila DASHDAMIROV, PRRC working within an AR (HOYA Surgical Optics GmbH) ;
Adam RAE, Outsourced PRRC (Founder of The Other Consultants)
- REGIONAL UPDATES
* PRRC requirements in some various Member States
(Sandra FERRETTI - Lead Representative PRRC, TEAM-PRRC ; Piero COSTA - Representative for Italy, TEAM-PRRC)
- IMPACT OF THE IMPLEMENTATION STUDY ON SHORT-TERM REGULATORY CHANGES
* Changes foreseen within the regulations
(Françoise SCHLEMMER – Director, Team-NB)
- CLINICAL EVALUATION & CLINICAL INVESTIGATION
* What is expected by the PRRC to fulfil the requirements ?
(Amie SMIRTHWAITE – MedTech consultant, Clinical & Regulatory Strategy, BTInternet)
- PMS & VIGILANCE: How the PRRC can ensure the compliance ?
(Breda KEARNEY - Clinical Regulatory Lead, BSI Ireland)
- A CASE STUDY presenting real examples from a SaMD manufacturer who used
their role to support the continuous safety of the devices on the Union market
(Alice RAVIZZA – Founder, InsideAI)
- Q&A and DISCUSSION WITH NOTIFIED BODIES
* MDR & IVDR Certification experiences, Transitional provisions,
overview of the future legislations and impact on the MDR & IVDR
(Maddalena PINSI – Head of MD, BSI Italy ; Daniele BOLLATTI – Technical Manager, IMQ ; Carlo GHERARDI – Lead Auditor, TÜV SUD ; Alessia FRABETTI – Head of MD,
KIWA CERMET Italy ; Selene MALVICINO – MD Manager, BUREAU VERITAS Italy)
- CLOSING SESSION WITH THE BOARD OF TEAM-PRRC
