Webinar
Medical Devices

Cracking the Code: MDR, IVDR and UKCA Classification and Indications for Use

Startup Edition Webinars series: Webinar 2 - 9 December 2025 - 16:00 GMT

Getting your device classified is one of the most critical steps

Missteps in defining the intended purpose or indications for use can lead to delays, additional costs, or even rejection of your application.

Breaking down the essentials of MDR and IVDR classification rules.
How to properly define indications for use in a way that aligns with regulatory expectations.
Clear explanations & practical examples in navigating the conformity assessment process.
How startups and small manufacturers can accelerate growth.
Prioritizing quality management and achieving device certification in the EU.

Speakers

Hear from the experts in this webinar

Speaker

Richard Holborow

Global Head Clinical Compliance at BSI

Speaker

Purvi Patel

Regulatory Lead (Medical Devices & IVDs) at BSI

Register for our BSI Insight Series: Startup Edition Webinars

Join us for this webinar series tailored for regulatory, R&D, and quality professionals, as well as founders of startups and small manufacturers.

This webinar series is designed for regulatory, R&D, quality professionals, and founders of startups and small manufacturers.

Team members from larger manufacturers seeking a broader understanding of quality and EU regulatory requirements will also benefit from this series.

11 November 2025 - 16:00 GMT

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In this webinar, we’ll introduce practical approaches to risk mapping that align with MDR and IVDR expectations, while staying realistic for resource-limited organizations.

You’ll learn how to identify risks early, link them to design and development activities, and use your risk map to guide smarter decisions throughout the product lifecycle.

13 January 2026 - 16:00 GMT

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This webinar will break down design controls and clinical planning into clear, actionable steps tailored for resource-limited organizations.

You’ll learn how to connect design activities with risk management, plan clinical evidence in line with regulatory expectations, and document your process effectively to support MDR and IVDR submissions.

10 February 2026 - 16:00 GMT

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This webinar will introduce startups and small companies to the fundamentals of human factors and usability engineering in the context of MDR and IVDR compliance.

You’ll learn how to integrate usability considerations early in development, reduce use-related risks, and strengthen your technical documentation for regulatory submissions.

10 March 2026 - 16:00 GMT

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This webinar will provide clear guidance on evaluating manufacturing pathways, including insourcing versus outsourcing, supplier considerations, and how to align your production strategy with MDR/IVDR requirements.

You’ll learn how to make informed decisions that balance quality, cost, timelines, and regulatory obligations—helping you bridge the gap between early development and successful market launch.

14 April 2026 - 16:00 GMT

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