As we know, the European Medical Device Regulations introduced in new requirements for medical device manufacturers, especially in the field of post-market surveillance and of these new requirements is related to the Summary of Safety and Clinical Performance (SSCP). In fact, specific documents like the Periodic Safety Update Report , post-market surveillance plan or the Post-market Clinical Follow-up are now required for medical device sold in Europe and new requirements have been introduced as well in the field of vigilance reporting, combination products and for the necessity to have a Person Responsible for Regulatory Compliance.
General Requirements for the Summary of Safety and Clinical Performance (SSCP)
The requirements for the Summary of Safety and Clinical Performance (SSCP) are established in the article 32 of EU MDR; moreover there is an MDCG guideline to further help manufacturers on the interpretation of the SSCP requirements.
The Summary of Safety and Clinical Performance (SSCP) is required for Class III and implantable medical devices. It is a document that will be published within the EUDAMED and it has to be written in such a way that it is clear to the end user, healthcare professional or patient.
The Summary of Safety and Clinical Performance (SSCP) shall be submitted to the notified body that has responsibilities to validate it. After validation, the notified body will publish the SSCP in the Eudamed database.
Particular attention shall be given to the readability of the Summary of Safety and Clinical Performance (SSCP). Firstly, there is the requirement about languages: in fact, the SSCP should be translated into the languages accepted in the Member States where the device is to be sold. Moreover, one section of an SSCP is for medical professionals and, for implantable devices or devices that are used directly by patients, one part is for the intended patients. Thus the document shall be clearly written as to be fully understood by patient with no medical expertise.
The Contents of the Summary of Safety and Clinical Performance (SSCP)
The European MDR describes clearly what shall be included in the Summary of Safety and Clinical Performance (SSCP).
Identification of the device
The first section of the Summary of Safety and Clinical Performance (SSCP) is related to the all the information needed to properly identify the medical device. This includes, for example:
- Device Name
- Manufacturer name, address and SRN (single registration number)
- Basic UDI-DI
- Classification of the device
- etc
Intended Use of the Device
The intended purpose of the device shall be included in the Safety and Clinical Performance (SSCP). The indications shall also be described (pathologies, specific medical conditions, etc) along with all the contraindications or restrictions/limitations for use.
Description of the Device
A description of the device shall be presented, including its operating principles and mode(s) of action. The main characteristics in terms of design (key functionalities, material in contact with the patient) shall also be mentioned.
Moreover, particular attention shall be given to the constituents of the device, such as medical substances, tissues or human cells, materials that can be absorbed into the human body or material that could have adverse effect on the patient.
Information on any residual risks and any undesirable effects
Residual risks are defined as “risk remaining after risk control measures have been taken”. According to the MDR, IFU shall contain information on any residual risks and any undesirable side-effects; thus the Summary of Safety and Clinical Performance (SSCP) should contain at least the same residual risks and side-effects mentioned in the Information for Use (IFU).
The summary of clinical evaluation
This section is intended for the healthcare professional and not for the patient. The goal of this section is to summative the clinical evaluation results, including evaluation of undesirable side effects and the acceptability of the befit-risk ratio.
All clinical investigations of the device in question, conducted before the CE- marking, should be summarised. A detailed list of information to be included is provided in the MDCG guideline .
Moreover, a summary of clinical data available for the device shall be included as well. This might include results of literature review, relevant information based on clinical data obtained from the implementation of the manufacturer’s PMCF and PMS plans or analysis of clinical data on medical device registries.
Therapeutic Alternatives
This section shall explain how the device is positioned in terms of risk/benefit analysis to therapeutic alternatives and the situations where these alternatives could be considered.
Training for Users
Education and training of the intended user shall be described, potentially including mandatory training before using the device.
Conclusions
In conclusions, we have been describing the main requirements associated to the SSCP – Summary of Safety and Clinical Performance, an essential document for Class III and implantable medical device. The requirements are coming from Article 32 of the European Medical Device Regulation 2017/745.
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