As part of the introduction of the MDR (Medical Device Regulation), manufacturers of medical devices of all classes will be required to prepare further (safety) reports in addition to the previous clinical evaluation. These reports, like the clinical evaluation, are part of the market surveillance after the medical device has been placed on the market. The plan is for these reports to be submitted to the EUDAMED database and also published there, thus making them accessible to both authorities and notified bodies. We have already informed you in detail about the PSUR (Periodic Safety Update Report) elsewhere.
In August, a guidance document of the Medical Device Coordination Group (MDCG) on the report on safety and clinical performance SSCP (Summary of Safety and Clinical Performance) was published: MDCG Guidance Documents 2019-9. The MDCG guidance documents replace the MEDDEV documents of the MDD in the context of the MDR. Therefore, we would like to take this opportunity to provide information on the report guidance.
First, a brief overview of the various required reports once again:
PMSReport: Post Market Surveillance Report; this report addresses risk class I products and is updated as needed. It contains data on the post-market surveillance activities according to the existing PostMarket Surveillance and their results, i.e. what data were collected and what conclusions were drawn with regard to the risk and benefits of the product, or whether the data collected are still sufficient to confirm the safety and performance of the product within the given intended purpose.
PSUR: Periodic Safety Update Report; this report addresses products in risk classes IIa, IIb, and III and is updated as needed or at least every two years for class IIa; 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 or 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, particularly in relation to the adverse events that occurred, i.e. corrective and preventive actions (CAPAs) carried out, as well as further information on the patient population that 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 line with the SSCP, the SSCP must also be adjusted in this course). In contrast to the PSUR and PMS report, this summary report on safety and performance is addressed directly to the user and thus also to the patient; accordingly, the aim of this report should be to write it in a language that is understandable and easy to follow for the patient. Like the Periodic Safety Update Report, the report is uploaded to the EUDAMED database and is thus available for public retrieval. Before uploading to the database, the draft version is subject to review and approval by the responsible notified body. What the SSCP has in common with the PSUR is that there must be a reference both on the product label and in the instructions for use of the corresponding product as to where the current version of the report can be found. This means an additional effort for the manufacturers to adapt especially the instructions for use beyond the further requirements of the MDR.
According to the guidance document, the SSCP report should now depict the following contents:
Revision history of the SSCP report
Information about the manufacturer of the medical device including the SRN number (Single Registration Number, automatically assigned by the EUDAMED system)
Information on the product itself including trade name and UDI coding
Information about the intended purpose of the product, the indications, the contraindications and possible hazards when using the product
Description of the history of the product with regard to predecessor products and changes in comparison, information on accessories or other products that are used in combination with the medical device under consideration (e.g., stent system: this usually requires a guide wire, an access sheath, etc., for use in accordance with the intended purpose).
Information on diagnostic and/or therapeutic alternative treatment methods, especially in the context of the risk-benefit balance
Information on harmonized standards and norms that are applied to the product under consideration
A brief summary of the currently valid version of the clinical evaluation and PMCF (if performed)
Information on the target user group and the recommended level of training of the user
Information on possible residual risks, warnings
If the SSCP is also addressed to patients, for example to patients who have received implants with a prescribed implant passport, or is directed to Class III devices for self-testing, the report should contain a separate section that addresses this issue; formulated in language that not only professionals, but also patients can comprehend and understand the content.
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 work for manufacturers, especially for implants and class III devices for self-testing. The guidance document requires that the SSCP be available in the languages of the European Union in which the product is marketed. If the product is intended for professional circles only, the already known language requirements for instructions for use with the country-specific specifications will apply. 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. Once the master version has been reviewed and the report has been uploaded by the notified body, the manufacturer usually has 90 days to make the other language versions available. If the evaluated master version was not in English, the notified body again has 15 days after receipt of the English version to upload it.
Only after the SSCP report has been approved by the notified body and subsequently uploaded to the EUDAMED database can (with a few exceptions of IIa and IIb implants) the respective product be placed on the respective market.
Due to the many different reports, a large amount of data has to be evaluated and further processed. Do you lack the time or the necessary resources for this? We would be pleased to support you actively in order to meet the requirements for post market surveillance according to MDR.
Please note that all data and listings are not intended to be complete, are without guarantee and are for information purposes only.
