Summary of Safety & Clinical Performance (SSCP)
A free guide to understanding & producing SSCPs for compliance with the MDR
What is a Summary of Safety and Clinical Performance (SSCP)?
The SSCP is a document that must be produced by manufacturers of all Class III and implantable devices (other than custom-made or investigational devices) under the Medical Device Regulation (EU) 2017/745. The Summary of Safety and Clinical Performance is an expression of one of the key aims of the MDR - to improve public access to the clinical data that underpins the safety and performance of medical devices.
All SSCPs must be submitted to and approved by a Notified Body. Once approved, the Notified Body will upload the completed SSCP into the EUDAMED database.
A well-written SSCP will provide information that will be relevant to healthcare professionals. Depending on the device, it may also need to contain information for patients and the general public. It will therefore need to be written in one or two sections, with appropriate choice of language to suit a professional and lay audience, as relevant.
The SSCP is not a replacement for the Instructions For Use (IFU) or implant cards that are associated with a device, nor is it intended to give general advice on the management of medical conditions. It should contain device-specific information with a focus on relevant safety and clinical data.
What are the specific requirements for the Summary of Safety and Clinical Performance (SSCP)?
The SSCP must be objective, including summaries of both favourable and unfavourable data. It should draw entirely upon information contained in the technical documentation relating to the device and should be updated when PMS, PMCF, Risk Management or Clinical Evaluation processes change such that the information in the SSCP becomes outdated.
The SSCP must be made available in English as well as the dominant language in all EU territories where the device is intended to be sold. The manufacturer is responsible for ensuring the accuracy of any translations.
A compliant SSCP will include the following nine sections:
- General device and manufacturer details (including UDI details)
- Intended purpose of device
- Indications, contraindications and target population
- Detailed description of device, including a description of any components such as medicinal products and any previous versions or variants of the device. Should include reference to alternatives to using the device
- Details of residual risks, warnings and precautions
- A summary of the Clinical Evaluation of the device and its PMCF activities in language that is appropriate to the reader, outlining evidence-based conclusions regarding the safety and performance of the device
- A description of necessary training and qualifications for use of the device
- A description of diagnostic and theraputic alternatives
- Harmonised standards and common specifications applied
Each language version of the SSCP should be a separate document, headed with a clear indication of the language used throughout. SSCPs will be formally reviewed for quality of content and readability, with approved SSCPs being published on EUDAMED.
Where can I find additional help in producing a Summary of Safety and Clinical Performance?
The SSCP is a core document in the regulatory portfolio of Class III and implantable products. It should be produced after taking professional advice regarding content and writing style.
The Medical Device Coordination Group has produced a range of guideline documents which have been updated to reflect changes introduced by MDR Article 32. MDCG 2019-9 rev 1 - Summary of Safety and Clinical Performance is an authoritative source of guidance that also provides a basic outline for structuring the SSCP.
Alongside structure, it is vital to ensure access to the level of medical writing expertise necessary to meet the challenge of writing for both technical and lay readers. Medical writing requirements may necessitate the involvement of dedicated professionals with the necessary levels of medical communication experience.
Mantra Systems offers a comprehensive SSCP service as part of our MDR consulting support, which has a 100% success rate for submissions under the EU MDR. Our team combines medical device regulatory specialists with clinicians who are experts in writing for professional and lay audiences. Please contact us to discuss this service in more detail.