Mastering EU MDR Clinical Evidence with BSI & Eclevar.

Co-authored by BSI Group and Eclevar MedTech. Discover how to align your clinical evaluation, PMCF strategies, and ISO 14155 investigations directly with Notified Body expectations.

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Inside the Whitepaper

A comprehensive guide on bridging the gap between manufacturer data and Notified Body requirements.

Key Insights

What you will learn.

CER Best Practices

Learn the precise architecture of a Clinical Evaluation Report that passes review on the first submission, eliminating costly Major Non-Conformances.

PMCF Strategy

Understand how to deploy Level 4 PMCF surveys and registries with pre-specified SAPs and validated instruments under MDCG 2020-7.

Legacy Devices

Gain actionable strategies for transitioning legacy devices to EU MDR, bridging historical data gaps with active post-market surveillance.

The Authors

A unique collaboration between assessor and builder.

bsi.

BSI Group is a leading global Notified Body, shaping best practices and defining the standards for safety and compliance in the medical device industry worldwide.

Eclevar MedTech is the specialist European CRO, combining regulatory expertise with clinical operations to build the exact evidence packages Notified Bodies expect.

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