How a cross-document terminology audit and translation memory review produced three MDR-compliant French documents with zero discrepancies between them.
The client
A manufacturer of coronary intervention systems producing a drug-eluting stent with a bioresorbable scaffold variant, classified as a Class III implantable device under MDR 2017/745. As part of the regulatory transition from the previous MDD framework, the French documentation package required updating across three interconnected documents – the Instructions for Use, the Summary of Safety and Clinical Performance (SSCP), and the Declaration of Conformity.
The challenge
Regulatory updates of documentation under MDR 2017/745 involves three documents: the IFU, the SSCP, and the Declaration of Conformity. They all needed to be terminologically consistent with each other, even though the regulatory register the IFU was originally translated in no longer matches what MDR requires.
The terminology issue ran deeper than individual term updates. The modal voice in contraindication and warning statements – a stylistic choice that carries direct regulatory meaning under MDR – had shifted between frameworks. In practical terms: a legacy MDD translation might render a contraindication as “this device should not be used in patients with…” where MDR-compliant IFU language requires “Do not use this device in patients with…” That distinction isn’t a choice; it reflects a required register shift that is not reflected in a term-by-term search. It requires reading each statement for its regulatory intent.
The SSCP introduced a specific challenge around the bioresorbable scaffold variant. In the clinical evaluation section, benefit-risk language had to preserve the designation “bioresorbable vascular scaffold” precisely – this term carries a defined regulatory meaning under the MDR clinical evidence pathway, and it couldn’t be rendered with synonyms drawn from the broader stent vocabulary without misrepresenting the device’s classification in the French text.
The solution
The three documents were treated as a single terminology project rather than three sequential translations. Before translation work began, we identified every point of terminological intersection – device classification language, intended use statements, and modal-voice warning constructions – and aligned French equivalents with MDR expectations, centralizing them in a shared term record.
The translation memory from the legacy MDD translation was audited for conditional phrasing before re-use, with imperative-register replacements documented and applied consistently across all three documents. Within the SSCP’s clinical evaluation section, the benefit-risk language for the bioresorbable scaffold variant was handled separately, with the “bioresorbable vascular scaffold” designation locked in the term record to prevent synonym drift across the delivery package.
The results
- One terminology framework across three interconnected regulatory documents – IFU, SSCP, and Declaration of Conformity – including full alignment of device classification language and intended use statements.
- Legacy MDD compliant phrasing was audited; imperative register substituted across all contraindication and warning statements, with changes documented in the shared term record.
- The designation “Bioresorbable vascular scaffold” was preserved throughout the SSCP clinical evaluation section, anchored in the shared term record to prevent synonym drift across the delivery package.
