Summary of Safety and Clinical Performance (SSCP)

A free guide to understanding and producing SSCPs for compliance with the MDR.

What is a Summary of Safety and Clinical Performance (SSCP)?

A 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 (MDR). 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 as well as the general public. It will therefore need to be written in two sections, with appropriate choice of language to suit a professional and lay audience respectively.

A 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, as appropriate. 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when PMS, PMCF, Risk Management or Clinical Evaluation processes change such that the information in the SSCP becomes outdated.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.

The SSCP, at a minimum, should include the following 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, 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
  • Harmonised standards applied
  • Revision history

Each language version of the SSCP should be a separate document, headed with a clear indication of the language used throughout. SSCPs will be reviewed for quality of content as well as choice of language and its suitability for the intended audiences.

Where can I find additional help in producing a Summary of Safety and Clinical Performance?

A SSCP is a core document in the regulatory portfolio of Class III and implantable products. It should be produced after consulting recognised guidelines and, preferably, 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 the MDR. MDCG 2019-9 - Summary of safety and clinical performance - a guide for manufacturers and notified bodies is an authoritative source of guidance that also provides a detailed template 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.

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FAQs

We have compiled some of our frequently asked questions. If you'd like to know anything else about what we do, feel free to ask us a question.

  1. We can work with the majority of medical device manufacturers seeking compliance of their devices in accordance with Medical Device Regulation (EU) 2017/745, including both hardware and software devices. We also offer a free, no-obligation consultation, so please feel confident about discussing your requirements with a member of our team.

  2. No. We will work with you to produce systems and to support your EU MDR compliance, but we do not conduct research ourselves. We will provide tools for you to conduct your own Post-Market Surveillance. Our range of services are designed to assist you in this matter.

  3. Yes. We adhere to the highest standards of professionalism and regard maintaining confidentiality and data security as a cornerstone of our practice. We also comply fully with the requirements of GDPR.

  4. Our medical device regulatory consulting is built around a strict quality framework and we only work with clients who share this commitment to quality. Our CEO is a medical doctor with years of experience in the medical device industry and assumes personal responsibility for every project. Our product development process integrates client feedback throughout product production, ensuring a constant focus on your needs.

  5. We work with clients of all sizes and at all stages of their regulatory compliance journey. Our team are here to help and are happy to respond to general enquiries, even if you don't feel like you know where to start. We are experts at 'tuning in' to your requirements and will guide you through the entire process. Our free MDR Compliance Guide and suite of MDR downloads stand as proof of our commitment to help you understand your obligations under the MDR.

  6. Yes. Software as a Medical Device is an increasingly-important segment of the medical device market. We have extensive experience in building regulatory systems for medical software and offer a special application of all our MDR services for software products. We also offer unique downloads and white papers that focus specifically on Software as a Medical Device.

  7. At its core, working with the MDR is about working with clinical evidence. Whether you need to generate evidence for PMCF, analyse data for writing a CER, or build an MDR-ready PMS system, our medical experts have the clinical acumen to ensure that your clinical evidence is produced and interpreted with the highest levels of professionalism. Medical professionals work with clinical evidence all day. We bring their specialist capabilities directly to your MDR strategy.

  8. We believe in transparency and aim to build long-term relationships with our clients. This commitment is demonstrated by our customer-focused pricing strategy. You pay a small deposit upfront, only paying the balance when the work has been completed to your total satisfaction. For higher-value projects we offer flexible payment packages on an individual basis — please contact a member of our team to find out more.

  9. Yes. Our unique business model allows us to scale to accommodate almost any amount of work. Many of our medical professionals remain clinically active, meaning that we have trained more than we presently need. This system allows us to have ready availability of redundant capacity that can be called upon in the event of a surge in demand. Whatever your requirements, our unique business model allows us to step in faster than any of our competitors.

  10. Yes. We run a number of events throughout the year focusing on specific aspects of MDR compliance. We also offer a limited number of free webinars on a limited basis — subscribe to our newsletter to be notified early when we publish new events. Of course, we also have our extensive MDR Compliance Guide and free MDR downloads suite, both of which offer extensive training on all aspects of MDR compliance.

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