Why Join This Series
Each webinar is led by the people who guide manufacturers through this process every day: our Notified Body regulatory specialists, IVD technical teams, alongside our commercial team.
Behind every submission are real people. Our team is approachable, open and ready to share the support, experience and expertise built over decades, all focused on supporting you as you move forward with confidence.
- Direct access to our experts -Talk with our regulatory specialists and dedicated technical experts, who bring deep scientific knowledge of the industry.
- Ask the questions that matter - An open fireside discussion and live Q&A in every session. Submit your questions when you register.
- Avoid the common pitfalls - Understand regulatory requirements and the deficiencies most often raised during assessment, before they cost you time.
- Built for the long term - Certification is just the beginning. Prepare for ongoing compliance across the full product lifecycle.
Who Should Attend
The series is designed for Class B and Class A sterile IVD manufacturers starting their IVDR journey, Class C and D manufacturers on their certification journey and for any other professionals involved in the regulatory process.
- Regulatory Affairs Managers And Specialists
- Regulatory Affairs Directors
- Quality And Regulatory Professionals
- SME Leadership, Including Managing Directors
Webinar 1 – The First Step: Navigating Your IVDR Conformity Assessment
📅 8 October 2026 |⏰ 09:00 BST or 16:00 BST
This webinar has now taken place.
Engaging a Notified Body under the In Vitro Diagnostic Medical Devices Regulation (IVDR) for the first time raises a lot of questions. This session explains the conformity assessment process step by step and the role of the Notified Body in your IVDR conformity assessment, giving you a greater understanding of where to start with your IVDR certification journey.
Webinar 2 – Building The Foundation: Structuring Technical Documentation Is Key
📅 22 October 2026 |⏰ 09:00 BST or 16:00 BST
Learn what Notified Bodies expect from IVDR technical documentation during an assessment; including how to align clinical evidence and quality management processes, and how to strengthen your documentation to avoid delays in your conformity assessment.
Webinar 3 – Life After Certification: Thrive In The Era Of IVDR Compliance
📅 10 November 2026 |⏰ 09:00 GMT or 16:00 GMT
Understand your ongoing obligations after IVDR certification: post-market surveillance, performance follow-up, and managing the changes that require Notified Body involvement.
Key Takeaways
Participants will leave the series with:
- Greater confidence engaging with Notified Bodies.
- A clearer understanding of IVDR conformity assessment expectations.
- Practical considerations for preparing robust regulatory documentation.
- Knowledge of how to sustain compliance throughout the product lifecycle.
- Best practice guidance from experienced regulatory experts and interactive discussions.
