The Summary of Safety and Clinical Performance (SSCP) is a regulated document which will be validated by the Notified Body (NB) during technical conformity assessment and made publicly available on Eudamed, the European database on medical devices. The SSCP, which is required under Article 32 of the EU Medical Device Regulation (MDR, 2017/745), is an important piece of information designed for the users of medical devices. It will provide both patients and healthcare professionals access to an updated summary of clinical and safety performance on medical devices.

On 26 September 2019, the Medical Device Coordination Group (MDCG), released a guidance on this summary. Once the MDR enters into force in May 2021, the SSCP will become mandatory for certain medium- to high-risk devices, including class IIa / IIb implantable devices and class III devices.

The Importance of Language and Translation

The SSCP is yet another regulatory enforcement within the ongoing transparency movement in the European medical community. Although public disclosure of research results is not a novel concept, both the new MDR and the new Clinical Trial Regulation (CTR) will now legally enforce public access to research and performance results for clinical trials and medical devices in the EU. With the SSCP, we see a requirement similar to the CTR, where a plain language summary of clinical trial results for laypersons must be made available after clinical trial completion.

In both new EU regulations, language and readability are key vehicles for bringing results to patients in non-technical, plain and local language. The importance of language is cemented in the MDCG guidance, which states that translations of the SSCP should be part of a manufacturer’s Quality Management System.

How to Comply with New Regulations from a Language Perspective

It will be your responsibility as a medical device manufacturer of high-risk devices to update the SSCPs during the lifecycle of your devices. The Notified Body is obligated to validate the SSCPs as part of the technical conformity assessment as well as at CE certificate renewals. After the Notified Body validates the initial SSCP based on a single, agreed-upon language, you need to translate the master SSCP into all relevant EU languages according to your market scope.

A note of caution here: the master SSCP may be accepted in a non-English EU language depending on the EU Member States in which your device is expected to be sold. If that is the case, you are also obligated to provide an English version within 90 days of the master being uploaded to Eudamed by the NB. The English version will subsequently be uploaded by the Notified Body within a further 15 days.

Upload of the remaining relevant languages depends on your launch plan as per EU Member State. As a principle, the translated summary must be available in Eudamed in local language before your product is distributed for sale in the concerned Member State. The translated versions beyond the master and English version are not subject to NB validation. However, the Notified Body is required to upload the summaries within 15 days after receiving them from you, the manufacturer.

How the Audience Impacts Language

Translations will be aligned with the language requirements for your Instructions for Use (IFUs) and may be subject to variations in language requirements across EU Member States. A particular linguistic challenge when authoring an SSCP for devices used directly by patients is that it is split into one part intended for healthcare professionals and another part for patients. As a manufacturer, you need to consider two different target audiences in the same summary. These audiences have very different health literacy skills for understanding and processing medical content.

You may even need to consider more than two audiences. If your device is intended for children, you need to consider if you direct your summary to the parents, to the children or to adolescent audiences. In addition, some devices may be intended for patient populations that are elderly or living with dementia, which will impact how well they understand the summary.

I will address the language challenges of the SSCP in more detail in our next blog in the MDR series.

How Medtech Manufacturers Can Manage Additional Regulations

To best prepare for the new EU requirements and reporting obligations, you should consider centralizing translations and establish a language workflow which can be adapted to any needed timeline. The SSCP requirement should be part of your gap assessment for MDR implementation and will require continuous document navigation.

The regulatory requirements on revision history, change control and validation status of the SSCPs are complicated by the multilingual nature of the EU market. The SSCP must be regularly updated across the device lifetime and contain information on which language version was validated by the NB. For manufacturers with extensive product portfolios, the management of documents and language versions will inevitably become a compliance activity.

Furthermore, the SSCP is cross-linked to other essential documents including the IFU, the Periodic Safety Update Report (PSUR), and Post-Market Clinical Follow-up (PMCF) reports. Updates of technical documentation require that the SSCP is revisited, revised with new relevant information in all languages, and then re-submitted to Eudamed. The PSUR and PMCF require annual updates or updates every two years.

Needless to say, because of the interdependencies across these core documents, content consistency and file management across all versions and languages will require increased resources and budget. This is where many manufacturers can and should look to language services providers. Such providers can help manufacturers manage the cycle of documentation updates as well as the language challenges of addressing more than one target audience in the same content piece.