Regulatory Compliance Guide for SSCP Professionals

The Safety and Clinical Performance (SSCP) is a crucial regulatory document that ensures high-risk implantable and Class III medical device manufacturers comply with EU MDR 2017/745 regulations. The SSCP is aimed at providing clear and accessible information about the safety, clinical data, and performance of a device, helping healthcare professionals and patients understand the device’s reliability. 

For manufacturers of high-risk devices, the SSCP is a mandatory requirement under Article 32 of the EU MDR. This document must be updated, validated by a notified body (NB), and made available to the public via the European database on medical devices (Eudamed). BioBoston Consulting offers expert guidance and support in navigating these complex regulatory requirements to ensure full compliance and effective communication with all stakeholders. 

 

Key Components of the SSCP 

The SSCP must provide an updated summary of clinical data, safety, and performance, as outlined in the technical documentation (TD) of the medical device. It serves as a vital source of information for healthcare professionals and patients, improving the transparency and accessibility of critical safety data. 

• Content: The SSCP is derived from various documents, such as design validation reports, risk management files, clinical evaluation reports, and post-market surveillance (PMS) plans. The SSCP should be factual, presenting both favorable and unfavorable data. 

• Target Audience: Healthcare professionals and patients (if applicable) are the primary recipients of the information in the SSCP. The document should cater to both groups by offering information at different levels of complexity. 

 

SSCP for Healthcare Professionals vs. Patients 

A well-prepared SSCP should address the needs of healthcare professionals and, when relevant, patients. 

• Healthcare Professionals: The SSCP for healthcare professionals must focus on clinical data and medical terminology pertinent to the device, offering a comprehensive understanding of its safety and performance. 

• Patients: For devices relevant to patients, particularly implantable devices and Class III devices directly used by patients, a patient-friendly section is essential. This part should be written in plain language, ensuring clarity and ease of understanding. 

 

Translation and Language Requirements for the SSCP 

Since the SSCP must be accessible in the languages of the EU Member States where the device is marketed, it is essential to provide translations in the relevant languages. Typically, a multilingual approach is required, with English being one of the common languages used in medical documentation. 

• Language Options: The SSCP should be available in the languages of the intended market. The EU MDR requires that translations be provided to meet local language requirements for both healthcare professionals and patients. 

• English Version: If the SSCP is not in English, manufacturers should provide an English version within 90 days of uploading the “master” SSCP document. 

 

Validation, Updates, and Public Access of the SSCP 

To ensure the accuracy and relevance of the information, the SSCP must undergo regular updates and validation by the NB. As part of the process, the SSCP must be uploaded to Eudamed, ensuring public access to the most up-to-date information about the device. 

• Initial Validation: During the initial conformity assessment, the NB validates the SSCP before issuing a certificate. This ensures that the SSCP contains the required elements and is aligned with the most current technical documentation. 

• Ongoing Updates: The SSCP must be reviewed and updated annually, particularly if new safety or clinical data becomes available. Any updates must be validated by the NB and uploaded to Eudamed. 

• Periodic Safety Update Report (PSUR): If the SSCP contains information that becomes outdated due to findings in the PSUR, an update to the SSCP is required to maintain alignment with the latest clinical data. 

 

Why BioBoston Consulting? 

At BioBoston Consulting, we specialize in helping manufacturers comply with the latest EU MDR 2017/745 regulations and navigate the complexities of the SSCP requirements. Our team of experts provides end-to-end support, from initial SSCP creation and validation to ongoing updates and translations. BioBoston Consulting ensures that all SSCP documents are tailored to meet diverse needs and comply with all necessary language and readability standards. 

 

Our services include: 

• SSCP Creation: We ensure your SSCP complies with all necessary guidelines and is written clearly for both healthcare professionals and patients. 

• Validation Support: We assist in the validation process with notified bodies (NBs) and guide you through Eudamed submission. 

• Regulatory Expertise: With our deep knowledge of the EU MDR, we help ensure your medical device stays compliant and meets all regulatory requirements. 

Let us help you maintain transparency and patient safety while ensuring your devices meet EU regulations efficiently. 

 

Get in Touch with BioBoston Consulting Today! 

Ready to ensure your device meets the highest standards of safety and clinical performance? Contact BioBoston Consulting today to learn how we can support your SSCP creation, validation, and regulatory compliance. Our expertise is just a call away!