As per EU MDR, for class III and implantable devices (other than custom-made or investigational devices), a manufacturer needs to provide a summary of safety and clinical performance (SSCP).
should be written in a way that is clear and easy to understand for patients as well as healthcare professionals. This will be validated by a notified body (NB) and made publicly available and this is expected to be an important source of information for the patients and health professionals.
Some of the key recommendations that manufacturer should consider while developing SSCP to ensure proper acceptance by a notified body.
- As SSCP Is meant for both patients and healthcare professionals as well. Hence it should be drafted appropriately to fulfill the objective for these end users/audience. It should provide information at and language/sentencing for these end customers to understand it easily
- Keeping their perspective in mind, it should be written in a simple, organized, consistent and unambiguous manner. This includes the explanation of medical terms in simple language. It would be appropriate to provide lay terms with a description first along with medical term to serve both types of audience
- The information provided in SSCP must be sourced entirely from technical documentation of the device which should be detailed, systematic and objective. This includes referencing design verification/validation reports, the risk management report, clinical evaluation report, post-market surveillance (PMS) and post-market clinical follow-up (PMCF) reports
- SSCP should also provide a precise and balanced summary of the clinical evaluation results of all the available clinical data related to the device, whether favourable, unfavorable, and/or inconclusive.
- SSCP should not be intended to provide general advice on the diagnosis or treatment of particular medical conditions and also it should not replace the IFU of the device. At the same, SSCP should help inform patients of any residual risks and side-effects with implantable devices and class III devices
- Another challenge is, wherever applicable, SSCP needs to be translated into the languages accepted in the EU Member States where the device is marketed. If SSCP is prepared originally in a non-English language, it is necessary to provide English translation of the SSCP and the document should state that in which language document is validated by NB
- Though SSCP will be validated and uploaded by NB on the Eudamed, it is manufacturer responsibility to ensure that SSCP and any translations have been made ready before placing a device on the EU market
Key elements of SSCP includes
Manufacturer + SRN
Device + UDI
Intended purpose, indications, contra- indications
Description, previous variant(s), differences, accessories, other products intended to be used in combination
Possible diagnostic or therapeutic alternatives
Harmonized Standards / Common Specifications
Summary of the Clinical Evaluation Report + PMCF
Suggested profile and training for users
Information on residual risks, undesirable effects, warnings & precautions