Multilingual SSCPs and SSPs: how to ensure consistency with instructions for use and technical documentation

A differently worded indication, an omitted contraindication or a discrepancy in a numerical value is enough to undermine the consistency of a regulatory dossier. In a multilingual environment, this risk increases when the SSCP or SSP, the instructions for use and the technical documentation are translated separately, from different versions or without common terminology.

Ensuring their consistency therefore goes beyond simple linguistic proofreading. This requires a unified documentation process, a clear hierarchy of sources, version control and systematic verification of critical information before publication.

Understanding the respective functions of SSCPs, SSPs and instructions for use

The SSCP, or ‘Summary of Safety and Clinical Performance’, is required under Regulation (EU) 2017/745 on medical devices. It applies to implantable devices and class III devices in particular. It provides the public with an up-to-date summary of the key information relating to safety and clinical performance.

The SSP, or ‘Summary of Safety and Performance’, serves a similar purpose under Regulation (EU) 2017/746 on in vitro diagnostic medical devices. It applies to class C and D devices and must be clear to the intended user and, where applicable, the patient.

These summaries do not replace the instructions for use. The instructions for use remain the primary document for the safe use of the device. The SSCP or SSP provides greater transparency, but must neither modify nor contradict the operating instructions.

Under Article 10(11) of the MDR, manufacturers must provide the information accompanying medical devices in the official Union language(s) determined by the Member State in which the device is made available, while Article 10(10) of the IVDR sets out the equivalent requirement for in vitro diagnostic medical devices.

Why do inconsistencies occur in multilingual versions?

The primary cause is the use of unsynchronised source documents. The instructions for use may have been revised after the SSCP was prepared, while the technical documentation may already contain a new indication, a different software version or an updated frequency for an adverse effect. If each translation follows its own schedule, discrepancies may arise even when each one accurately reflects its source document.

The second cause relates to terminology. The same concept may have several linguistically acceptable translations, but these may be incompatible from a document consistency perspective. Terms relating to the intended use, target population, residual risk or user action must not vary depending on the translator or file type. Terminology consistency should be managed at product level, rather than separately for each project.

Building consistency into the process before translation

The first step is to identify the approved version of each document and the reference source for each category of information. SSCPs, SSPs and instructions for use must not be treated as separate files, but as a single set of documents. Some fields must remain identical, while others can be adapted to the target audience without altering the underlying facts.

Creating a device-level glossary

The glossary should cover device names, components, indications, contraindications, target populations, risks, adverse effects and required user actions. Each entry should include the source term, its approved translation, its definition and, where necessary, prohibited wording.

This glossary is then applied to the instructions for use, SSCP or SSP, the labelling and other regulated content. Specialised medical device translation therefore goes beyond simply assigning the text to a medical translator: it requires consistent terminology management throughout the documentation lifecycle.

Using a shared translation memory

A shared translation memory facilitates the reuse of approved segments, particularly for warnings, indications and wording related to the intended use. However, it does not replace the glossary or regulatory validation and may contain outdated wording. Critical segments must therefore be associated with a clearly identifiable document version.

Performing a cross-document review

A cross-document review compares the instructions for use, the SSCP or SSP and the relevant sections of the technical documentation. Performed by someone familiar with the product, it verifies terminology, data, conditions of use and the scope of warnings.

Which elements should be systematically compared?

The cross-check should focus on information that could affect the identification, intended purpose, safety or performance of the device.

For each element, the matrix identifies the approved source, the relevant documents, the target translation and its validation status:

• the trade name, models, variants and Basic UDI-DI (Unique Device Identifier);
• intended use, indications and target populations;
• limitations, contraindications and exclusion criteria;
• warnings, precautions and user actions;
• residual risks and undesirable effects;
• components, materials, substances and accessories;
• performance characteristics and claimed clinical benefits;
• storage, transport, installation and operating conditions;
• quantitative data, units, durations and frequencies;
• software versions or configurations that could affect safety.

Organising a cross-document review of medical documentation before publication

A possible workflow includes the following steps:

1. confirm the version and approval status of the source documents;
2. extract the critical fields into a comparison matrix;
3. apply the approved glossary and memory;
4. have the translation carried out by a specialised linguist;
5. carry out an independent review in the target language;
6. compare the translated SSCP or SSP with the corresponding instructions for use;
7. carry out automated checks on numbers, units, codes and prohibited terms;
8. refer discrepancies to regulatory affairs;
9. record decisions and approvals;
10. check the laid-out files before publication.

Automated checks can quickly identify formal discrepancies, but they cannot determine whether two formulations have the same clinical or regulatory implications. This decision requires human assessment. Good IFU translation therefore combines linguistic tools with a contextual review focused on the actions that the user actually needs to understand and perform.

EU regulatory requirements emphasise the importance of controlled processes for ensuring that the information supplied with medical devices, including labelling and instructions for use, complies with the applicable requirements.

Managing versions and post-market updates

Consistency must be maintained throughout the device’s life cycle. A change to the clinical evaluation, performance evaluation, PSUR (Periodic Safety Update Report), PMCF (Post-Market Clinical Follow-up) or PMPF (Post-Market Performance Follow-up) may render part of the summary or instructions for use obsolete. Each approved change should therefore trigger a documentation impact assessment. To explore this topic further, see our article on the concepts of ‘accurate’ and ‘up-to-date’ translation under the MDR.

The manufacturer remains responsible for the accuracy of translations and must ensure their effective management through its quality management system. The traceability of linguistic approvals is therefore essential.

Adapting the text to the target audience without changing its meaning

The SSCP may include a section intended for healthcare professionals and, where relevant, a section intended for patients. The MDCG guidance recommends consistent medical terminology in the section intended for healthcare professionals and clear, plain-language explanations in the section intended for the general public.

Adapting the text to the target audience must not result in the omission of an important restriction. A technical term may be explained, but the risk, its frequency and the appropriate course of action must remain aligned with the approved source documents. It is useful to record the professional term and its plain-language equivalent in the glossary to prevent each translator from creating their own simplified version.

The role of a specialised language service provider

The manufacturer retains regulatory responsibility for its documents and their approval. A specialised provider can, however, structure linguistic assets, apply the agreed controls and provide the traceability records needed to integrate translation into the manufacturer’s quality management system.

A translation company working on this type of content must be able to work with the approved versions, preserve safety-related wording, organise an independent review and document terminology decisions. It must also be able to distinguish between a purely linguistic correction and a discrepancy that may require the involvement of the regulatory affairs.

Before the launch, the provider should be given the approved instructions for use, the relevant technical documentation, previous versions, glossaries, regulatory decisions and the critical field matrix. The more comprehensive the context provided, the less likely the translator will be to interpret an ambiguity that should instead be referred to the manufacturer.

Conclusion

Ensuring consistency between the translation of an SSCP or SSP and the instructions for use requires these documents to be managed as consistent versions of the same regulatory information. The reference sources, product glossary, translation memory, consistency matrix, cross-document review and change control should be integrated into a single traceable process.

This approach reduces terminological discrepancies and, above all, contradictions concerning the intended use, risks, warnings and performance. When integrated into the quality management system from the source preparation stage, translation becomes a controlled step in the documentation lifecycle rather than a late-stage check before market launch.