MDR Clinical Evaluation Report authored for a Class IIb device — every claim source-linked, submission-ready in 8 weeks

Pain points before the engagement

• MDR clinical evidence burden was overwhelming the small in-house medical writing team
• Clinical data spanned multiple studies with different data-collection standards
• Auditors and Notified Body reviewers were asking for traceable claims — not just cited claims
• Prior CER drafts had gone through multiple rounds of Notified Body questions on evidence provenance
• The submission window was fixed and non-negotiable

Problem

The device supports clinical treatment planning and had been developed over several years alongside investigator-led studies. MDR requires a CER with clinical evidence that a Notified Body reviewer can walk end-to-end. Prior CER submissions from similar devices had cycled through multiple rounds of NB questions on whether specific clinical claims were adequately supported. The team needed a CER where the answer to "where does this claim come from?" was one click, not one week.

Approach

TraceDraft ingested the source clinical data across the contributing studies. The CER template was populated section-by-section with claims linked to their source clinical facts. The review queue put source-link counts in front of the reviewers so they could focus attention on any thinly-grounded claims before submission. The evidence pack travelled with the exported CER so the Notified Body reviewer could see the traceability chain without a separate request.