We live in a world where medical devices serve as silent sentinels, tirelessly protecting and improving lives. From the subtle hum of pacemakers that synchronize heartbeats to the precise delivery of medication by insulin pumps, these innovations are nothing short of modern marvels. But with every breakthrough comes a duty – to guarantee these devices remain safe, effective, and reliable. This is where the narrative of Summary of Safety and Clinical Performance (SSCP) unfolds, illuminating the path from complex clinical data to informed, life-saving decisions.
the role of safety, security, and compliance
The primary goal of safety standards is to guarantee that medical devices perform their intended functions without causing harm to patients or users. Given the critical nature of these devices, any lapse in safety, security, or compliance can lead to adverse outcomes, including patient injury or data breaches.
- Safety protocols involve rigorous testing and validation procedures to prevent accidental harm and ensure compliance with established safety standards.
- Security protocols protect devices from cyber threats and unauthorized access. As devices become more interconnected, the risk of cyberattacks that could compromise patient data or disrupt healthcare services grows.
- Compliance protocols ensure that medical devices adhere to the regulatory requirements imposed by governing bodies, such as the FDA in the United States or the EMA in Europe. Adhering to these regulations is crucial for obtaining market approval and maintaining device certification.
the genesis of safety, security, and compliance directives & regulations
In the early days, medical devices were simple and mechanical. As technology advanced, these devices evolved, becoming more complex and interconnected. The shift from mechanical to software-driven devices introduced new challenges. It was no longer enough for a device to simply function; it had to do so reliably, safely, and securely, especially in the face of potential cybersecurity threats.
a turning point in medical device development
Consider a revolutionary development: an internet-connected pacemaker that could be monitored and adjusted remotely, offering unprecedented convenience and care. However, this innovation also posed significant cybersecurity risks. Hackers could potentially manipulate the device, leading to life-threatening situations.
Recognizing the need for rigorous standards, scientists, engineers, and regulators collaborated to create a robust regulatory framework ensuring that medical devices operate without compromising patient safety or data security. They realized that safety and security are intrinsically linked: a device isn’t safe if it’s vulnerable to cyberattacks, nor is it secure if its safety mechanisms are flawed. Through a holistic approach and rigorous testing, they launched the device with the highest safety and security standards in place.
fast forward to MDR and SSCPs
This case study became a model for the entire medical device industry, showing that with the right standards and dedication, it is possible to create devices that are both innovative and safe. However, this requires a deep understanding of both the medical and technological landscapes. As technology evolves, standards must be continuously updated to keep pace with emerging threats and innovations. Harmonizing these standards across different regions remains a significant challenge.
implementing the SSCP
The SSCP serves as a comprehensive document that encapsulates key aspects of a medical device’s efficacy and safety. By transforming complex clinical data into clear, patient-friendly insights, the SSCP bridges the gap between technical information and practical understanding, empowering healthcare professionals and patients to make well-informed decisions with confidence.
The SSCP is a critical requirement under the new Medical Device Regulation (MDR 2017/745). According to the Medical Device Coordination Group: “This document is one of several means intended to fulfil the objectives of the MDR to enhance transparency and provide adequate access to information.”
Enforcement of the MDR has been postponed several times due to the COVID-crisis, the lack of transparency and clarity of the recertification requirements of devices, and because of the long waiting list to get reassessed by notified bodies. Enforcement of the new MDR is depending of the class of device, enforcement is currently envisioned for 2027 or 2028.
what the MDR says about the SSCP (article 32(1))
- For implantable devices and for class III devices, other than custom-made or investigational devices, the manufacturer shall draw up a summary of safety and clinical performance.
- The summary of safety and clinical performance shall be written in a straightforward way for the intended user and, if relevant, for the patient.
- The draft of the summary of safety and clinical performance shall be part of the documentation to be submitted by the manufacturer to the notified body involved in the conformity assessment pursuant to Article 52. The notified body will validate the SSCP.
- After its validation, the notified body shall upload the summary to EUDAMED to allow for public access.
- The manufacturer shall:
- mention on the label or instructions for use where the summary is available
- have its location mentioned on the device label or instructions for use by the manufacturer
- respect the stylistic and readability recommendations within MDCG 2019-9
- The information in the SSCP should be sourced entirely from the technical documentation of the device.
Key aspects of an SSCP also include medical device identification (intended purpose, classification, and unique identifiers), safety and clinical performance data, risk-benefit analysis, instructions for use, target audience information, and post-market surveillance follow up. Again, the SSCP is intended to be accessible and understandable to both healthcare professionals and patients, promoting informed decision-making and enhancing the overall safety and transparency of medical devices in the EU.
What makes the creation and publication of SSCPs challenging?
While SSCPSs are crucial for transparency and safety under the new MDR, their creation and management present significant challenges for manufacturers and regulatory bodies.
increased complexity, volume, and requirements
Compiling and harmonizing comprehensive data on safety and clinical performance is particularly challenging for high-risk or innovative devices. The sheer volume of data – including post-market surveillance, clinical evaluations, and risk management – is a challenge as it often comes from different trials across different geographies. And keeping this information up-to-date and resubmitting revised SSCPS for validation can be overwhelming.
balancing readability with technical accuracy
SSCPs must strike a balance between being scientifically accurate and understandable to non-experts. Ensuring that complex medical or technological information is conveyed clearly without oversimplifying is critical, especially for advanced or innovative devices.
SSCP translation and localization
SSCPs must be available in all official EU member state languages where the device is marketed. Ensuring accurate SSCP translations while maintaining the integrity of the information across multiple languages, often under tight deadlines, can be both challenging and costly without the right translation partner.
resource constraints
Developing, updating, and maintaining SSCPs requires significant resources, including expertise in clinical, regulatory, and technical fields. For many manufacturers, particularly smaller SMEs, allocating sufficient resources to meet MDR requirements can be a major and costly challenge.
timing and coordination
The SSCP must be finalized and approved before a device can be marketed, necessitating careful coordination with the overall regulatory submission timeline. Delays in SSCP preparation can impact market access. The MDR requires SSCPs to be audited annually, be regularly updated based on post-market data and resubmitted to the notified body for revalidation. Keeping these documents current in response to new clinical evidence or safety information can be an ongoing burden.
public availability and confidentiality
Since SSCPs are publicly accessible, they may expose sensitive commercial information. Manufacturers must carefully manage data privacy and security concerns during the creation, updating, and translation of these documents.
expert review and validation
SSCPs must undergo rigorous review and validation by Notified Bodies before publication. This process can be time-consuming, requiring multiple rounds of revisions and clarifications to ensure all regulatory requirements and standards are met.
post-market surveillance and vigilance
Vigilant post-market surveillance is essential to maintain device safety and performance. Manufacturers must implement robust systems to track and analyze safety data, including adverse events and corrective actions. Ensuring this data remains accurate and up-to-date within the SSCP requires constant monitoring and effective communication.
meet regulatory & compliance goals with CQ fluency
Creating and managing SSCPs under the new MDR (MDR 2017/745) presents numerous challenges for manufacturers, from increased complexity and language requirements to regulatory compliance and resource allocation. At CQ fluency, we understand these complexities and are committed to supporting our medical device customers in navigating the MDR and SSCP translation requirements. Leveraging our regulatory and scientific expertise, we ensure multilingual SSCP content is compliant, accurately translated, and delivered promptly, allowing our customers to meet their regulatory submission deadlines.
AUTHOR
Clio Schils
vice president, global life sciences
As VP of Global Life Sciences at CQ fluency, Clio ensures the highest quality and efficiency across a broad spectrum of clinical translations, from pharmacovigilance to linguistic validation. She has played a pivotal role in fostering global partnerships with leaders in pharmaceuticals, medical devices, biotech, and more. With a passion for patient understanding and advocacy, Clio continues to drive innovation in multilingual communication. Reach out to Clio and her team to learn how CQ fluency can help bridge communication in the life sciences industry.