Italy LNG Virtual Event: Navigating the IVDR: Notified Bodies’ Expectations and Regulatory Updates

This event will take place in Italian

The transition to the In Vitro Diagnostic Regulation (IVDR) represents a significant regulatory and operational challenge for many IVD manufacturers, particularly for those engaging with a Notified Body for the first time. Increased scrutiny, evolving guidance, and higher expectations around evidence generation require a clear understanding of regulatory requirements and practical implementation strategies.

This webinar provides a comprehensive overview of the IVDR landscape, with a specific focus on the expectations of Notified Bodies and the latest regulatory developments. Participants will gain insight into key elements of IVDR compliance, including the structure and content of technical documentation, transition strategies from the IVDD, post-market surveillance (PMS) requirements, and the generation and maintenance of robust clinical evidence.

The session is designed to support companies at an early stage of their IVDR journey, offering practical guidance on how to prepare for interactions with Notified Bodies, common pitfalls observed during conformity assessments, and best practices to ensure a smoother certification process. Real-world perspectives and regulatory insights will help attendees better align their internal processes with current regulatory expectations.

This webinar is particularly relevant for regulatory affairs professionals, quality managers, and companies new to the IVDR Notified Body process who are seeking clarity, structure, and actionable guidance to navigate compliance with confidence.

Registration Fees & Deadlines

Speakers

Marta Carnielli
Head of Certification IVD, TÜV SÜD

Sara Fabi
Regulatory Lead IVD, BSI

Paolo Acquafondata
Industrial engineer - Lead Auditor, 13485:2016 - RCC IVDR - Lead Implementer ISO 22301:2019Expert in: IVDR 746/2017-ISO 15189:2013-ISO 20387:2018-ISO 14971:2019-ISO 31000:2018, UCB

Carlo D'Alessandro
Direcetor, Quality and Regulatory, Donawa Lifesciensce Consulting

Malagari Christina
Quality Assurance Officer, ProGnosis Biotech

Proof of Attendance

A certificate of attendance can be downloaded from the RAPS Learning Portal following the event.

Questions