SSCP and SCP Translation for Clinical and Performance Summaries

SSCP translation is the multilingual translation of the Summary of Safety and Clinical Performance, a public-facing regulated document required for certain medical devices under MDR. It summarises intended purpose, clinical performance, benefit-risk profile, residual risks and key clinical evidence, often with professional-user and patient-facing versions. AbroadLink delivers SSCP translation with qualified medical and clinical linguists, MDR-aligned terminology, translation memories and traceability through CertLink, under risk-based workflows aligned with device, content, audience and target Member States. The service supports regulated documentation work without replacing client-side clinical, regulatory or QARA responsibilities.

SCP translation is the multilingual translation of the Summary of Safety and Performance, a public-facing regulated document required for certain IVDs under IVDR. It summarises intended purpose, performance, safety and key clinical or performance evidence relevant to the IVD. AbroadLink delivers SCP translation with IVD-aware linguists, IVDR-aligned terminology and structured review aligned with the performance information and audience expectations of the document. The service supports IVD manufacturers as a specialised language partner. Final IVDR compliance, notified body acceptance and EUDAMED publication decisions remain with the manufacturer and qualified bodies.

SSCP (Summary of Safety and Clinical Performance) applies to certain medical devices under MDR (Regulation (EU) 2017/745). SCP (Summary of Safety and Performance) applies to certain IVDs under IVDR (Regulation (EU) 2017/746). Both are public-facing regulated summaries, but they address different product types, frameworks and audience structures. SSCPs often include separate professional-user and patient-facing versions. SCPs focus on performance information for IVDs. AbroadLink supports both with appropriate medical device or IVD linguists, terminology resources and risk-based workflows. The applicability, structure and audience versions are defined by the manufacturer and applicable regulatory framework.

Summary of safety and clinical performance translation is typically requested by Clinical Affairs Managers, Medical Writers, Regulatory Affairs Managers and PRRCs in MedTech and IVD manufacturers. It supports multilingual documentation across Member States and audiences where MDR or IVDR expectations apply. AbroadLink delivers SSCP and SCP translation under ISO-based workflows, with traceability through CertLink. The service supports clinical and regulatory documentation operations. Final regulatory acceptance, notified body decisions, EUDAMED publication, clinical evidence sufficiency and product approval remain with the manufacturer and qualified stakeholders.

SSCPs and SCPs are regulated, public-facing summaries of safety, clinical performance or performance information for medical devices and IVDs. They summarise intended purpose, benefit-risk profile, clinical evidence and key safety information for professional and lay audiences. Translation must accurately and completely reflect the approved source content across terminology, claims, references and benefit-risk wording. AbroadLink supports accurate SSCP and SCP translation under risk-based workflows, but accurate translation does not, by itself, guarantee notified body acceptance, EUDAMED publication, clinical evidence sufficiency, patient understanding or product approval, which depend on broader processes.

No. The accuracy expectation for SSCP and SCP translation does not change with workflow. Exact, complete and source-faithful translation is always the objective. Different workflows manage the risk of failing to achieve accurate clinical summary translation through different review depths, controls and evidence. A lower-risk workflow may be appropriate when the device, content, audience, target markets and client-side controls support that choice. A higher-risk workflow applies when translation errors in clinical evidence, performance wording, benefit-risk language or patient-facing summaries could carry more serious consequences for the manufacturer and intended users.

The legal or regulatory requirement under MDR or IVDR is that SSCP and SCP content accurately reflects the approved source for each Member State and audience. That requirement applies regardless of workflow. AbroadLink's risk-based translation approach is a workflow decision: it determines how translation risk is managed through review depth, ISO 17100 revision, linguistic risk assessment and evidence. It does not change the accuracy requirement. Manufacturers select workflows based on device, content, audience and internal controls. Regulatory approval, notified body acceptance, EUDAMED publication and clinical evidence validation remain owned by the client.

Yes, in a controlled way and with care. Through aiHubLink, AI pre-translation can use client terminology and legacy summaries as references for suitable sections, always followed by qualified human medical validation under ISO 9001, ISO 17100 and ISO 13485-based processes. The AI model used is identified on the signed translation certificate. For benefit-risk wording, clinical evidence, performance claims, patient-facing summaries and high-risk device content, AI is positioned cautiously and used only when suitable. The workflow is agreed in advance with the client, with human review remaining central.

No. SSCP translation, SCP translation, MDR clinical summary translation, AI-assisted translation, linguistic risk assessment and traceable evidence through CertLink support regulated teams handling clinical and performance summaries under controlled processes. However, they do not guarantee MDR compliance, IVDR compliance, notified body acceptance, authority acceptance, EUDAMED publication, clinical evidence sufficiency, clinical validity, benefit-risk acceptability, patient understanding, QMS acceptance, product approval, CE marking, market access or business outcomes. These depend on device design, clinical evidence, regulatory strategy, QMS overall design and the assessments of notified bodies, competent authorities and EUDAMED processes.