IVDR Performance Evaluation: Practical Pathways for IVDs, RUO and In-House Devices

Webinar overview

Getting performance evaluation right under the IVDR is essential - and it doesn't have to be over-engineered. In this focused 60-minute session, ProductLife Group will clarify what manufacturers truly need to demonstrate, what does and does not apply to Research Use Only (RUO) products and how expectations differ for in-house IVDs. You'll leave with clear next steps to accelerate compliance and keep projects on schedule.

Why this session matters

Performance evaluation sits at the heart of the IVDR. Teams often struggle to balance scientific rigor with proportionate evidence, to scope documentation that notified bodies actually expect and to navigate the boundary between commercial IVDs, RUO materials and in-house devices. This webinar translates the regulation into practical, right-sized actions - so you can maintain momentum from strategy through submission.

What you'll take away

• A proportionate strategy: how to design a performance evaluation that satisfies IVDR requirements without over-engineering evidence packages

• Clear classification & obligations: how to distinguish IVDs, RUO products and in-house devices and what regulatory duties apply to each category

• Inspection-ready documentation: what evidence and records notified bodies expect before submission and how to organize them.

• Risk reduction in practice: common pitfalls that delay market access (and how to avoid them) to protect timelines and resources

How PLG supports your roadmap

• Regulatory strategies for IVD companies (portfolio and pathway planning, EU/UK/US alignment)

• Performance evaluation services (planning, evidence generation, documentation, NB interaction)

• Targeted workshops and coaching for teams and stakeholders

• Manage the transition to IVDR with proportionate, stage-appropriate plans

• Streamline performance evaluation strategies and templates across products and geographies

• Understand product-specific requirements based on regulatory status (IVD, RUO, in-house)

Event details

Register here