4 Challenges of SSP and SSCP Language Requirements

Lionbridge has been exploring Summary of Safety and Clinical Performance (SSCP) language requirements in our blogs since 2019. The SSCP is a new type of regulatory document required under the EU Medical Device Regulation (2017/745). We’re committed to continue sharing guidance and perspectives on SSCP language compliance throughout the implementation of EU reforms on medical devices. This blog will cover our practical recommendations on SSP and SSCP translation requirements and language standards as we receive more customer summaries. Critically, these summaries can be challenging and should ideally be woven into your device’s life cycle language strategy.

A New Content Type with Challenges and Opportunities

 The Summary of Safety and Clinical Performance (SSCP) and the Summary of Safety and Performance (SSP) are regulated documents requiring validation by a Notified Body (NB) during technical conformity assessment under the European medical device regulations. The SSCP is a requirement under the Medical Device Regulation (MDR), and the SSP is required under the In Vitro Diagnostic medical device Regulation (IVDR). Both summaries will be publicly available on EUDAMED - the European database established for medical devices under the EU reforms.  

The summaries are an essential type of information designed for medical device users and part of an ongoing regulatory effort to increase transparency within the European MedTech market. They will provide patients and healthcare professionals with updated information on devices’ clinical and safety performance. For patients, the summaries are an opportunity to become empowered to make informed decisions about their own health and learn about the device’s risks and undesirable effects.  

While industry guidance is available on the SSCP, only a template has been published on the SSP for In Vitro Diagnostic devices (IVDs), which may challenge IVD manufacturers. Since no upcoming guidance is announced in the MDCG plans, Lionbridge recommends that manufacturers of IVDs follow the SSCP guidance when preparing, updating, and translating summaries. Although devices differ, the challenges with developing and translating the summaries are similar.  

Lionbridge Has Observed Four Specific Challenges:

• Stylistic and audience challenges 

• Dependency on multiple living documents 

• Translations into multiple languages 

• Readability testing methodology 

Challenge 1: Stylistic and Audience Challenges

 Since the SSCP/SSP is sourced entirely from the technical documentation, there is a risk that language style is carried over from technical source documents to the summaries. This results in a jargon-filled regulatory language. This impact defeats the core purpose of the summaries, which were built into the European regulations to enhance transparency rather than to serve as a regulatory tick-box exercise. The intended users of the summaries may include professionals and patients, depending on the device’s intended usage. Given the summaries are also disclosed on EUDAMED in local language, the general public becomes a third target audience.  

Writing for multiple audiences in the same document is not ideal due to the language gap between professional medical language and plain language. Manufacturers should, therefore, be mindful of the intent of the summaries and never use them to replace the Instructions for Use.  

To tackle these communication challenges, we recommend manufacturers set up a style guide for the summaries and use plain language as far as possible without distorting the device’s performance and safety evidence. This may mean that phrases such as the intended use statement or risk sections should be worded slightly differently than in the technical sources to ensure they are understandable to all audiences, particularly patients.  

We’ve observed that style guides are notably effective for clinical trial sponsors required to publicly disclose a plain language summary of clinical trial results under the EU Clinical Trial Regulation (536/2014). A style guide will be valuable for writing and translating summaries. For more advice on authoring in plain language, we recommend the Good Lay Summary Practice handbook under EudraLex Volume 10 (co-authored and edited by Lionbridge’s Pia Windelov).  

Challenge 2: Dependency on Multiple Living Documents

 The SSCP/SSP is a written and continuously updated living document based on multiple technical documents that change over the device lifecycle. It must be updated to reflect current knowledge of the device’s safety and performance. Therefore, manufacturers should determine when to update a summary to reflect a device’s current benefit-risk profile and remain transparent about existing data.  

Changes may be triggered when new evidence is generated on a device or during regulatory reporting obligations through the product’s life cycle. Whereas documents such as the Clinical Evaluation Report and Performance Evaluation Report must be updated in regular cycles, the SSCP/SSP must be updated as needed. Controlling data lock points for the summary and across these interdependent documents may challenge manufacturers. We’ve learned from the industry that NBs focus on alignment across all interconnected documents. Based on this info, we recommend manufacturers incorporate SSCPs/SSPs into a product life cycle language strategy that helps ensure control of all interdependent documents and their translations.  

Challenge 3: Translation into Multiple Languages

The MDCG guidance states that translations of the SSCP should be part of the manufacturer’s Quality Management System to ensure accuracy. Notified Bodies (NBs) will only validate a summary in the manufacturer’s language and in English if not identical. The NBs will upload a validated summary on EUDAMED within 15 days of the validation and when the initial certificate is issued. Translated summaries in local languages are required within 90 days of validation of the master SSCP/SSP for member states where the device is sold.  

Translation quality relies heavily on source text quality. Lack of alignment across technical documents will carry over to medical device translations. Again, a product life cycle language strategy will help control all content during the device life cycle in both source and target languages. Simply relying on Translation Memories set up at enterprise or functional levels won’t be as efficient as setting up a strategy and language assets at the product level. Also, when the cross-functional team meets annually to update technical documentation, they’ll benefit from a pre-defined and consolidated language approach.  

Challenge 4: Readability Testing Methodology

Readability testing is used in the Life Sciences industry to confirm that information is written and presented at a literacy level appropriate for the intended users’ level of knowledge. NBs will expect a readability test from manufacturers. However, the MDCG guidance allows manufacturers to determine an adequate methodology to confirm readability.  

At this stage of MDR and IVDR adoption, manufacturers seem to primarily use freely available Flesch-Kincaid scoring system to test readability. This system was established in the 1940s and adopted by the US Navy for technical manuals. The Flesch Kincaid, available via MS Word, has clear limitations. This is because it’s only based on length of sentences and words. A document may have an acceptable score with short sentences and few syllables, but the content may be gibberish and inaccessible to the reader.  

At Lionbridge, we offer a more advanced Linguistic Toolbox with multiple built-in scoring systems to provide a more nuanced result, e.g., by looking at passive versus active voice. Expectations for readability testing may evolve as NBs validate more summaries. In any case, the rounds of questions during NB conformity assessment are limited. Manufacturers should be prepared to justify any omissions of readability testing or choice of methodology.   

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