As part of the introduction of MDR (Medical Device Regulation), manufacturers of medical devices of all classes are obliged to prepare further (safety)reports in addition to the known clinical evaluation. Like clinical evaluation, these reports are part of market surveillance after the medical device has been placed on the market. It is planned that these reports will be transmitted to and published in the EUDAMED- database, where they will be accessible to both public authorities and notified bodies. We have already provided you with detailed information on the PSUR (Periodic Safety Update Report) elsewhere.
In August, the Medical Device Coordination Group (MDCG) published a guide to the Summary of Safety and Clinical Performance (SSCP): MDCG Guidance Document 2019-9. The MDCG guidance documents replace the MEDDEV documents of the MDD within the framework of the MDR. We would therefore like to take this opportunity to inform you about the guidelines for this report.
First of all, a brief overview of the various reports requested:
- PMS Report: Post Market Surveillance Report: this report is aimed at risk class I products and is updated as necessary. It contains data on postmarket surveillance measures and their results, i.e. which data have been collected and conclusions drawn regarding the risk and benefits of the product or are the collected data still sufficient to confirm the safety and performance of the product within the given purpose.
- PSUR: Periodic Safety Update Report; this report is aimed at products of risk classes IIa, IIb and III and is updated as required for class IIa or at least every two years; an annual update is mandatory for class IIb and class III. In addition to the contents of the Post Market Surveillance Report, the PSUR also contains detailed information / an assessment of the riskbenefit ratio and the resulting conclusions, information on the results of the Post Market Clinical Follow-up (PMCF), an overview of the units sold of the product, in particular in relation to undesirable events that have occurred, i.e. corrective and preventive measures taken (CAPAs), as well as further information on the patient population that has received the product, i.e. ultimately the frequency of use of the product.
- SSCP: Summary of Safety and Clinical Performance; this report is required in addition to the PSUR for products in risk class III and for implants and must be updated annually (if the PSUR has been updated and now contains information that is not in accordance with the SSCP, the SSCP must also be adjusted accordingly). In contrast to the PSUR and the PMS report, this short report on safety and performance is aimed directly at the user and thus also the patient; accordingly, the aim of this report should be to write it in such a way that it is understandable and comprehensible for the patient. Like the Periodic Safety Update Report, the report is uploaded to the EUDAMEDdatabase and is therefore publicly available for download. Before being uploaded to the database, the draft version must be checked and approved by the competent notified body. The SSCP has in common with the PSUR that both the product label and the instructions for use for the corresponding product must indicate where the current version of the report can be found. For manufacturers, this means an additional effort in adapting the instructions for use, in particular, beyond the further requirements of the MDR.
According to the Guidenace-document, the SSCP-Report should now contain the following content:
- Revision history of the SSCP Report
- Information on the manufacturer of the medical device including the SRN number (Single Registration Number, automatically assigned by the EUDAMED-system)
- Information about the product itself including trade name and UDI-coding
- Information on the intended purpose of the product, the indications, contraindications and possible hazards associated with the use of the product.
- Description of the history of the product with regard to previous generations and differences in comparison, information on accessories or other products used in combination with the medical device under consideration (e.g. stent system: this usually requires a guidewire, an access lock, etc. for use as intended).
- Information on diagnostic and/or therapeutic alternative treatment methods, especially in the context of risk-benefit considerations.
- information on harmonised standards and standards applied to the product under consideration
- A brief summary of the current valid version of the clinical evaluation and PMCF (if performed)
- Information on the user profile and recommended training level of the user
- Information on possible residual risks, warning notices, etc.
- If the SSCP is also addressed to patients, for example patients who have received implants with a prescribed implant card or Class-III-products for self-testing, the report should contain a separate section dealing with this issue; worded linguistically in such a way that not only experts, but also patients, can understand the content of the report.
In addition to the content requirements for the SSCP, the Guidance-Document also contains other requirements for the layout and format of the report. In particular, the requirements for availability in different languages will lead to additional costs for manufacturers, especially for implants and Class-III-products used directly by the patient. The Guideance-document provides for the SSCP being available in the languages of the European Union in which the product is marketed. If the product is only intended for specialist circles, the already known language requirements for instructions for use apply with the country-specific specifications. An English version of the SSCP should be made available in any case. The manufacturer is ultimately responsible for all necessary translations of the report. After the master version has been checked and the report uploaded by the notified body, the manufacturer usually has 90 days to provide the other language variants; if the evaluated master version was not written in English, the notified body has 15 days after receipt of the English version to upload it again.
Only after approval of the SSCP-report by the notified body and subsequent upload in the EUDAMED-database can the respective product (with few exceptions of IIa and IIb implants) be placed on the market.
Due to the many different reports, a large amount of data has to be evaluated and processed further. You don't have the time or resources to do this? We are happy to support you actively in order to meet the requirements of Post Market Surveillance according to MDR.
Please note that all data and listings do not have the claim of completeness, are without guarantee and serve the pure information.