Clinical Affairs
PSUR & SSCP
Regularly updated reports about safety and summary about safety and the clinical services.
You have created a clinical evaluation report? Very good; but have you also taken the time to think about the Periodic Safety Update Report and the Summary of Safety and Clinical Performance?
PSUR & SSCP under the MDR
Both documents are used for comprehensive monitoring of the medical device sector in Europe. Although all companies are expected, because of the rising requirements in a Post-market surveillance system, to proactively self- monitor their devices. Additionally, the notified bodies are now also taking a closer look. Increased transparency should also enable the public to respond to potential security risks.
These exact facts are the kinds of topics that the clinical evaluation report researches. The report analyzes the risk-benefit ratio and questions the indications which can be used on the device. At the same time, the risks are studied. To aid this, scientific articles, clinical studies, and information from the Post-Market Surveillance System are used.
Subsequently, all risks are set against the benefits and compared with the state of the art. From this, one can confirm or deny if a device is safe, and if the intended therapy is appropriate for the time. The most important question to be asked in this situation is if there is an alternative that will provide the same outcome with less of a risk factor. One example is the insulin therapy pen pump or shot.
PSUR: The regularly updated report on safety
In the Medical Device Regulation (EU) 2017/745, all manufacturers which have medical devices from the class lla are required to periodically submit an updated report about the topic of safety (Periodic Safety Update Report, PSUR). This report will create an overview of all the updated safety pertaining changes in correlation with the medical device and replaces the PMS report. The requirements for the PSUR are defined in article 86 from the MDR. The article consists of marketing information for medical devices and the most important results from the risk management and Clinical evaluation.
By the way; the pharmaceutical industry has been aware of the periodic safety update report for some years now. The introduction of the PSUR in the Medical Device sector shows once again that the two fields are moving ever closer together in regulatory terms!
SSCP: The Safety and Clinical Performance Summary Report
The Summary of Safety and Clinical Performance (SSCP) is based on article 32 from the MDR and is used for implantable medical devices and medical devices of the highest risk class III. The summary encompasses an overview of the Medical Device itself and the Clinical Evaluation. The SSCP is created by our team, in cooperation with the European guidelines of the MDCG (MDCG 2019-9).
Why is it necessary that I acquire the PSUR as well as the SSCP? What is the difference between the two documents?
The SSCP is created in addition to the PSUR, although some of the content is identical. The document will be available online for patients and users and should therefore be prepared with great care and updated regularly. The PSUR is usually given to the Notified Body; and even though it is simply called a summary, the SSCP is noticeably more detailed than the PSUR.
News
Clinical evaluation of eyeglasses
Both prescription and non-prescription eyeglasses are considered medical devices under the regulatory framework of the Regulation (EU) 2017/745.
Clinical Evaluation for Medical Devices in China
The field of medical devices is rapidly evolving, and as technological advancements continue, so do the regulatory frameworks governing their approval and marketing.
20 years of medical technology approval
We are celebrating our anniversary. We have been a partner to the healthcare industry for 20 years and support companies with the approval of medical products
Regulatory Affairs Update 25/23
Areas: Europe, Worldwide / Updates, New regulations and guidances 25/23
