The new regulations (MDR: Regulation [EU] 2017/745 and IVDR: Regulation [EU] 2017/746) create an enhanced level of protection for users, and a high standard of both quality and safety for these devices. The update also includes additional requirements for traceability and information transparency, increased oversight of notification bodies, revised clinical investigation practices and improvements to other areas, such as post-market surveillance.
These changes are designed to tackle common safety concerns and risks associated with these types of devices, and to provide a straightforward and efficient framework in which to work. The implementation of these changes requires device manufacturers to assess their own standards and practices to ensure full compliance.
While these changes were made in 2017, the COVID-19 pandemic delayed enforcement until 26 May 2021. Now the regulations are in place, manufacturers must implement any necessary changes.
Part of the new requirements (article 32 of the MDR) includes considering patients as a target audience. Manufacturers will also have to prepare a summary of safety and clinical performance (SSCP) annually to remain compliant. This presents a significant challenge that requires comprehensive planning and execution.
What is an SSCP?
Regulation (EU) 2017/745 requires device manufacturers to create a summary of safety and clinical performance (SSCP). This applies to implantable and class III medical devices, excluding custom-made or investigational devices.
Once created, the SSCP needs to be validated by a notified body (NB). It will then be publicly available from Eudamed, the EU database for medical devices.
After the validation, manufacturers are required to submit the SSCP and periodic safety update reports (PSURs) to the NB, providing annual updates in line with each device’s technical documentation (TD).
Implantable devices that require patient implant cards and class III devices for patient use
The SSCP must include a section for patients who are using devices that either require a patient implant card or are classified as class III devices for patient use. However, the SSCP should not provide advice concerning diagnosis or treatment of any medical condition. Furthermore, it should not be used to replace any medical device document, such as the implant card or any instructions for use (IFU).
Article 32 of MDR 2017/745 describes the requirements of the SSCP in detail. For further guidance on the SSCP, the EU published MDCG 2019-9: Summary of safety and clinical performance, A guide for manufacturers and notified bodies.
Key elements required on an SSCP
- Device identification and general information
- Device’s intended use (purpose, indications, contraindications and target populations)
- Device description
- Risks (any residual risks and undesirable effects) and warnings
- Summary of the clinical evaluation and relevant information on post-market clinical follow-up
- Possible diagnostic or therapeutic alternatives to the device
- Suggested profile and training for users
- Reference to any harmonised standards and common specifications
- Revision history
Writing SSCP templates
If you’re writing an SSCP template for your company, it’s vital to ensure you cover all the requirements. To help you get it right, we’ve created a summary of the key points, necessary steps and essential content:
Create two templates
It’s important to create two different SSCP templates in line with the MDCG 2019-9 guide. A technical template should be designed for use by healthcare professionals, and a lay person-friendly template should be designed for patients and other users.
Use an appropriate style and layout for each audience. Ensure the use of audience-appropriate language, considering comprehension for differing literacy levels.
If you are required to create and submit both healthcare professional and patient sections of the template, the section for use by healthcare professionals should precede the section for use by patients.
Content
- Include product information for users
- Summarise available clinical data for the device, whether favourable, unfavourable or inconclusive.
Ensure the SSCP content is fully up to date with the latest version of any technical documentation supplied with the device.
Potential sources for content information
- Device instructions for use (IFU)
- Design verification and validation reports
- Risk management reports
- Clinical evaluation reports
- Post-market surveillance (PMS)
- Post-market clinical follow-up (PMCF) reports.
Use appropriate medical and technical terminology
For healthcare professionals
When designing the SSCP template for use by healthcare professionals, use appropriate medical and device-specific terminology, clinical context and abbreviations commonly used in medical care settings.
For patients
The SSCP template for patients should be written for the lay person. This means omitting the use of any non-essential medical or technical terminology, clinical context of medical abbreviations.
Target your language to an 11 to 14-year-old’s reading level to ensure maximum comprehension while also providing all the necessary information. If it isn’t possible to replace any specific medical terminology, it should be explained clearly in lay person-friendly language.
The readability of the document should be assessed by using a valid metric tool. If possible, ask a relevant patient advocacy group to review the document.
Graphs and tables
Include graphs and tables to enhance readability where possible and appropriate. This may include quantitative data, such as the side effects and residual risks of using a device.
Simple infographics can improve reader comprehension and provide a better overall reading experience. Make sure you consider people with disabilities when creating infographics: for example, the use of alternative fonts or colours can improve legibility. Ensure any infographics are assessed to avoid a promotional appearance or any intellectual property/copyright violations.
Localise all content
You are required to produce an English version of your SSCP. The MDR also recommends the creation of the SSCP in the official language of each EU member state where the device will be sold, as well as the languages required for IFUs in that member state.
Translations should be carefully checked to ensure accuracy using back translation methods.
Disclaimers
Add disclaimers to your template that make it clear that the SSCP isn’t intended to provide advice or information regarding treatment of any medical conditions. Ensure the content directs patients or users to contact a medical professional for such advice or information.
In addition, make it clear that the SSCP is not intended to replace an implant card or the IFU, nor should it be used as a replacement. Furthermore, the SSCP is not intended to provide any diagnostic advice or information about potential therapies, treatments or other device uses.
What action do manufacturers need to take immediately?
As soon as Eudamed goes live, SSCPs will be accessible to the public. Device manufacturers need to take action immediately to ensure compliance with the MDR guidance for SSCPs, including verifying the language translations required, in order to bring a device to market in the EU.
Presenting the information is challenging and time is now critical to ensure SSCPs are in place, including translated SSCPs for all EU member states.
Semantix can help you write the templates you need for your medical devices and in vitro diagnostics, including translations to more than 200 languages. We have specialist medical translators waiting to help you make sure that your SSCPs are fully compliant with the new regulations.
