EC Offers MDR Guidance on New Safety and Clinical Performance Summary

Regulatory NewsRegulatory News | 30 September 2019 |  By 

The European Commission’s Medical Device Coordination Group recently released guidance to help manufacturers create a new summary of safety and clinical performance (SSCP), as required by the EU’s Medical Devices Regulation (MDR) for implantable devices and for class III devices that are not custom-made or investigational.

The SSCP, which will be validated by a notified body (NB) and made publicly available via the EU database on devices known as Eudamed, is expected to be an important source of information for device users and health professionals.

In particular, the guidance says the SSCP should help inform patients of any residual risks and side-effects with implantable devices for which patients will be given implant cards and class III devices intended to be used directly by patients.

For health professionals, the SSCP will also provide an “objective and balanced summary of the clinical evaluation results of all the available clinical data related to the device in question, whether favourable, unfavourable, and/or inconclusive,” among other information.

But the guidance warns that the SSCP is not intended to give general advice on the diagnosis or treatment of particular medical conditions, nor replace the instructions for use (IFU) as the main document to ensure the safe use of a particular device, nor will it replace the mandatory information on implant cards or other documents.

However, the guidance notes that the SSCP should contain information on at least the same residual risks and undesirable side-effects as included in the IFU.

“It should also be clarified in the SSCP whether quantitative data on side-effects or residual risks relate to clinical data that were obtained proactively, for example from a structured prospective follow-up study of the device itself, or if the expected frequencies come from a systematic review of the scientific literature. It should be disclosed in the SSCP if data from spontaneously reported incidents or serious incidents are used as one of the sources for estimating quantitative data on side-effects or residual risks, in which case significant under-reporting needs to be considered,” the document notes.

And the information in the SSCP also should be sourced entirely from the technical documentation (TD) of the device, the MDCG says. “Examples of such documents are design verification/validation reports, the risk management report/file, the clinical evaluation report, and post-market surveillance (PMS) and post-market clinical follow-up (PMCF) plans and reports,” the guidance says.

The guidance also discusses the validation of the SSCP by notified bodies (NBs).

“When the NB has assessed that all the required elements are included in the draft SSCP, accurately presented and in alignment with the most current version of relevant documents in the TD, the SSCP has been validated by the NB,” the document says.

The required sections of the SSCP, including the identification of the device and the manufacturer, as well as the Basic UDI-DI and, if already issued, the single registration number, are also further discussed in the document.

MDCG 2019-9 Summary of safety and clinical performance A guide for manufacturers and notified bodies


© 2022 Regulatory Affairs Professionals Society.

Discover more of what matters to you

No taxonomy