Die SSCP (“Summary of Safety and Clinical Performance”) is not the only relationship that the MDR required by many medical device manufacturers. The content of the SSCP even overlaps with the PSUR and PMS report.

Die IVDR presents with that SSP (“Safety and Performance Summary”) almost identical requirements.

How do all these relationships differ from each other? How can manufacturers avoid duplication of work and wasted effort? This article provides answers and seven plus a tip.

1. SSCP/SSP: Why another relationship?

The SSCP (“Summary of Safety and Clinical Performance”) or SSP on the one hand and the PSUR (“Periodic Safety Update Report”) on the other both report on safety. However, they have different goals, audiences, and guidelines on when and how they should be created and updated (Table 1).

Manufacturers are burdened with an additional report with the SSCP, the Summary Report on Clinical Safety and Performance (or the SSP for IVD manufacturers). At the same time, it allows producers to control and formulate audience information more specifically for the target group.

2. What should the SSCP/SSP contain?

a) MDR and IVDR compliant content

When selecting content, producers are subject to legal requirements. The MDR sets them out word for word in Article 32 and the IVDR in Article 29. Accordingly, SSCPs must include:

1. the product and manufacturer identification including the basic UDI-DI and, if already issued, the SRN;
2. the intended purpose of the product and all indications, contraindications and target groups;
3. a description of the product, including a reference to any previous generations or variants and a description of the differences and, where applicable, a description of all accessories, other products and products intended to be used in combination with the product;
4. possible diagnostic or therapeutic alternatives;
5. a reference to all harmonized standards and GS applied;
6. the summary of the clinical evaluation in accordance with Annex XIV and relevant information on post-marketing clinical follow-up;
7. the proposed profile and user training;
8. Information on possible residual risks and side effects, warnings and precautionary measures.

b) MDCG specifications

In MDCG Guideline 2019-9, the MDCG specifies a chapter structure for the SSCP and MDCG 2022-9 similarly specifies a chapter structure for the SSP. The latter distinguishes between self-test products (directly aimed at patients/non-professionals) and non-self-diagnostic products (aimed at professional users and, if necessary, at patients/non-professionals).

The chapter structure proposed by the MDCG specifies even more precisely the content required by the MDR and IVDR. A simplified representation is shown in Figure 1.

3. Where does the data come from?

The content summarized in the Short Report on Safety and Clinical Performance (SSCP) or SCP comes almost exclusively from the technical documentation (see Fig. 2).

IVD and medical device manufacturers are required to translate the SSP or SSCP into the relevant languages ​​of the EU destination countries where the product is to be marketed.

Manufacturers then send all versions to the respective notified body, which checks one (!) language version. The notified body can verify whether the data contained in the short report actually corresponds to the data contained in the TD. For example, compare the information contained in the V&V reports, risk management, clinical evaluation or performance evaluation, post-market surveillance, PMCF/PMPF and IFU with the information contained in the SSCP/SSP.

If successful, the notified body will upload all language versions to EUDAMED (see Fig. 3).

4. Tips for creating the SSCP

Tip 1: Get the right people involved

The short safety and clinical performance report can be understood as the essence of the technical documentation intended for the public.

Experts from the following areas should be involved in creating this short report:

• Clinical Affairs (most important role)
• Regulatory Affairs (ggf. Legal)
• Quality Management, also the PRRC
• Risk management
• Product management

Tip 2: Update the report along with the PSUR

As new data becomes available, the SSCP should be updated. This will happen at the latest when a new version of the PSUR (“regularly updated safety report”) becomes available.

Tip 3: Avoid discrepancies between TD and SSCP/SSP

Informing the public – including competitors – of all risks and issues can be difficult and can lead people to “embellish” the data. But the same applies here too: honesty lasts longer.

You should also avoid unintentional discrepancies. A slightly different indication or differently worded safety instructions quickly lead to unnecessary discussions with the notified bodies.

Tip 4: Use clear language

Unlike clinical evaluations or performance evaluations, the SSCP or SSP should not be formulated like a scientific publication with many “internal abbreviations” and (incomprehensible) technical terms, but should be adapted to the target group. This also includes lay people.

If necessary, it is useful to divide the SSCP/SSP into areas intended for lay people and specialized users. For IVDs this is even specified by MDCG 2022-9.

Tip 5: Get a professional translation

DeepL and Google Translate do a great job. But they do not replace a professional translation. At least the fine tuning of the SSCP/SSP must be carried out by a person who knows the target language and understands its content.

Tip 6: Use the 2019-9 or 2022-9 MDCG guidance

You will avoid discussions with your notified body if you stick to both the chapter structure and the content specified in the MDCG 2019-9 and MDCG 2022-9 guidelines.

Tip 7: Don’t forget to include usability engineering

Even lay people should understand the brief report. This means that, in addition to the instructions for use, you have another document that you should take into account when checking suitability for use, for example during the summative evaluation.

Bonus Tip: Automate SSCP creation

Almost all of the information that the “Safety and Performance Brief Report” must contain comes from the technical documentation. Often even identical letters. Therefore, much of the work consists of copying, structuring and formatting content.

These are tasks that a computer can complete without errors in a fraction of a second.

5. Conclusion and summary

For higher class products the “Summary of Safety and Clinical Performance” (SSCP) is mandatory. For IVDs, this report is called the “Summary of Safety and Performance” (SSP). Both result in additional costs for the manufacturers of these products.

These reports provide transparency into product risks and effectiveness. This may not please all manufacturers, especially since the competition also has an idea.

But there is also good news:

1. The requirement to publish an SSCP applies only to higher class products.
2. For safe, high-performance products, SSCP/SSP and EUDAMED create another channel through which manufacturers can communicate the quality of their products.
3. Thanks to the MDCG 2019-9 and MDCG 2022-9 guidelines there is clarity on what the report must contain and how it must be structured.
4. There is no need to collect new data for the report. They can already be found in the technical documentation.
5. Thanks to digitalization, it is possible to minimize the work required to create SSCPs or SSPs.

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