In addition to the known clinical evaluation, the introduction of the MDR (Medical Device Regulation) obliges manufacturers of medical devices of all classes to prepare further (safety) reports. Like the clinical evaluation, these 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 informed you about the PSUR (Periodic Safety Update Report)and the experience after 2 years with it in our other blog articles.
In August 2022, the Medical Device Coordination Group (MDCG) published the updated guidance document on the Summary of Safety and Clinical Performance (SSCP). This SSCP is required for class IIb implantable devices and all class III devices – so-called high-risk devices. Class IIa implantable devices may also be affected.
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 post-market 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 2 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 risk-benefit 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. The MDCG Guidance 2022-21 published in 2022 explicitly addresses the requirements for the preparation of the PSUR and also provides a proposal on how a possible reporting form should be designed. Another special feature of the PSUR is that manufacturers of class III devices or implantable devices submit their safety reports to their Notified Body via the electronic system referred to in Article 92 (EUDAMED). The Notified Body shall review the report and include its assessment in that electronic system, together with details on any action taken. These safety reports and the assessment of the Notified Body shall be made available to the competent authorities via this electronic system.
- 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 EUDAMED database 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. In addition, the manufacturer is obliged to indicate on the product label as well as in the instructions for use of the corresponding product where the current version of the SSCP report can be found. For manufacturers, this means an additional effort to adapt the instructions for use, in particular, beyond the further requirements of the MDR; a review of the usability may even be requested here.
According to the Guidance document, the SSCP Report should 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 expenses for manufacturers, especially for implants and class III products used directly by the patient. The guidance document specifies that the SSCP must be 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 versions; 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, the respective product (with few exceptions of IIa and IIb implants) can be placed on the market.
The updated version of MDCG-2019-9 from March 2022 addresses another important topic in the field of labelling – Basic UDI-DI – and establishes the link with the SSCP: In the EUDAMED database, an SSCP is basically always linked to one or more Basic UDI-DI(s). All UDI-Dis/products connected to this Basic UDI-DI will therefore have the same SSCP. If the medical device is a system of multiple components/devices, each device in the system should have a Basic UDI-DI, but the manufacturer is encouraged to also maintain a Basic UDI-DI for the system. The SSCP form provides corresponding sections for this, which should be observed in order to ensure clear allocation.
Due to the many different reports, a large amount of data has to be evaluated and processed. 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.
