The transition from the Active Implantable Medical Device Directive (AIMDD) and Medical Device Directive (MDD) to the Medical Device Regulation (MDR) is well underway, impacting all medical devices and their corresponding technical documentation. A new requirement of the MDR for implantable devices and for Class III devices is the summary of safety and clinical performance (SSCP). Read on to learn where the SSCP fits into your MDR submission.
What is a summary of safety and clinical performance (SSCP)?
The SSCP is intended to provide public access to updated information regarding the safety and clinical performance of your implantable and/or Class III medical device (excluding custom-made or investigational devices). The SSCP is considered the core regulatory document for these devices.
9 sections that should be included in the SSCP:
- Identification of the device and the manufacturer, including the basic unique device identifier (UDI-DI) and the single registration number (SRN)
- The intended purpose of the device and any indications, contraindications, and target populations
- A description of the device, including a reference to previous generations or variants (if any exist) and a description of the differences, as well as, where relevant, a description of any accessories, other devices, and/or products intended to be used in combination with the device
- Information on any residual risks and undesirable effects, warnings, and precautions
- The summary of clinical evaluation as referred to in Annex XIV of the MDR and relevant information on post-market clinical follow-up (PMCF)
- Possible diagnostic or therapeutic alternatives
- Suggested profile and training for users
- Reference to any harmonized standards and common specifications applied
- Revision history of the SSCP
The SSCP should provide objective information and include summaries of both favorable and unfavorable data as appropriate. MDCG 2019-9 provides a guide on how to approach the required sections of an SSCP and includes a template. Additional information on the SSCP can also be found in the MDR, Article 32.
Who will read the SSCP, and how can you best address readability?
The SSCP is meant for healthcare professionals first and foremost, but if the device is intended for patient use, it must also include an additional section specifically for the patients who will use the device. Duplicate information is typically presented in both sections, but the language used in each section should reflect the different levels of knowledge held by each target audience (i.e., patients versus healthcare professionals). The patient-specific section of the SSCP should be written using language that will be readable and readily comprehensible to patients with differing levels of knowledge. A safe rule to follow when writing this section is to assume that the patients who will read it have no formal medical training or other knowledge of clinical research. For assistance in determining whether your SSCP meets this requirement, a readability test can be performed on www.readable.com or by using MS Word readability statistics.
In which language(s) should the SSCP be available?
With 24 official languages in the European Union, it’s safe to say that no single language will be understood by all intended users and patients. Therefore, the SSCP should be translated into the languages accepted in the member states where the device is intended to be sold. A good rule of thumb is to provide the patient-targeted SSCP section in all the languages required for the Instructions for Use (IFU) in the different member states. Please note that the notified body (NB) only validates the “master” SSCP; it is the manufacturer’s responsibility to make sure a translation will be made available for the NB to upload to EUDAMED.
How will the SSCP be made available to the public?
The SSCP is meant to be read by the intended user, but how can we make sure this information reaches the correct recipient? Since the SSCP is part of the MDR submission, it has to be validated by the NB. The NB, being the only actor allowed to manage SSCPs on EUDAMED, will upload the SSCP. According to GSPR 23.4(d), a link to the SSCP must be provided in the IFU. While EUDAMED is not yet fully functional, it is advisable to insert a link to the manufacturer’s website where the SSCP has been uploaded.
How frequently is an SSCP update needed?
The manufacturer is responsible for keeping the SSCP up to date after it has been submitted, making the necessary adjustments as regularly as needed to maintain the required consistency of the information provided across the SSCP, CER, IFU, and risk management documentation. An update to the SSCP is required when an update to the periodic safety update report (PSUR) demonstrates that information in the SSCP is incorrect or incomplete.
What common mistakes are typically made?
Notified bodies report that the most common mistakes they encounter are inconsistencies between the SSCP, CER, IFU, and risk management documentation. The SSCP is far more than a simple summary — it is seen as the core regulatory document of a device, so it would be a serious mistake to leave writing the SSCP to the very last moment, or to omit a thorough internal review before submission. It is highly recommended to keep the SSCP in mind when writing related documents, such as the CER, as aligning the information therein with the requirements of the SSCP will make completing certain sections of the latter document a faster and simpler process.
How can Avania help with your SSCP?
Avania is a contract research organization specialized in medical devices. Our medical writing team has extensive experience conducting and writing various regulatory documents concerning — but certainly not limited to — CERs, clinical investigation reports (CIRs), post-market surveillance (PMS), PMCF, and SSCPs.
If you have a Class III and/or implantable medical device, the SSCP will form an important part of your MDR submission. Avania has the technical know-how and experience to support the writing of your SSCP and ensure content alignment with your CER, IFU, and risk management documentation. Our insight and in-depth experience make Avania the perfect choice to assist you in drafting your SSCP.