Summary of Safety and Clinical Performance (SSCP) is a new Regulatory requirement applicable for high-risk implantable and class III devices manufacturers. SSCP for these high-risk devices is imposed by the Article 32 of EU MDR 2017/745 and should include information about safety, clinical data and clinical performance of device. The document shall be accessible to the intended end users of the devices, either the healthcare professionals and/or patients. The SSCP shall be validated by a notified body (NB) and made available to the public via the European database on medical devices (Eudamed).
The SSCP is intended to provide public access to an updated summary of clinical data and other information about the safety and clinical performance of the medical device. The SSCP will be an important source of information for intended users – both healthcare professionals and if relevant for patients. It is one of several means intended to fulfil the objectives of the Medical Device Regulation (MDR) to enhance transparency and provide adequate access to information.
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 that will be provided to ensure the safe use of a particular device, nor
- Replace the mandatory information on implant cards or in any other mandatory documents.
The main purpose of this document is to provide guidance on the presentation, content and validation of the SSCP. The word “shall” is used when there is a corresponding “shall” in the MDR, otherwise “should” or “recommended” etc. is used indicating the interpretation of the MDR.
General requirements and recommendations for the SSCP
The information in the SSCP should be sourced entirely from the technical documentation (TD) of the device. 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 IFU includes information extracted from the same sources as the SSCP, but may itself be used as a source for the SSCP if appropriate.
The manufacturer will assign to the SSCP an identifier (reference number) that within the manufacturer’s management system is unique to that SSCP and will remain the same for the entire lifetime of the SSCP. In combination with the manufacturer’s SRN this will allow for the unique identification of the SSCP in EUDAMED and in EU.
The SSCP shall be kept updated in Eudamed. When the PMCF evaluation report and the periodic safety update report (PSUR) are updated at least annually, the SSCP shall be reviewed and updated if needed to ensure that any clinical and/or safety information in the SSCP remains correct and complete. When updating the SSCP, all sections of the document shall be updated if needed so that they are in alignment with the most current version of the relevant parts of the TD of the device.
This guide outlines the minimum content of the SSCP. The manufacturer may add further information from the TD of the device to enhance the comprehension of the mandatory information providing:
- It does not affect the readability of the SSCP and
- It excludes any element of a promotional nature.
The SSCP shall be objective and adequately summarise both favourable and unfavourable data
For further guidance on the contents of the SSCP, please refer to sections 1-8 of this document and to the template in the Appendix. The format and structure of this template is recommended. It addresses all of the SSCP content requirements of the MDR, but the order has been revised to enhance its presentation.
The IFU shall contain all that is needed to directly find the SSCP in Eudamed. The following applies to the IFU
- It shall state that the SSCP is available in the European database on medical devices (Eudamed), where it is linked to the Basic UDI-DI.
- It should provide the URL to the Eudamed public website: https://ec.europa.eu/tools/eudamed
- It should state the value of the Basic UDI-DI. Alternatively, another metadata can be stated provided it can be used to unambiguously search and find the intended SSCP in Eudamed.
Translations to other EU languages
No single language will be understood by all intended users and patients in the EU – see the European Survey on Language Competences initiated by the European Commission. In order to meet the requirement in the MDR that the SSCP shall be written in a way that is clear to the intended user and, if relevant, to the patient, the SSCP should be translated into the languages accepted in the Member States where the device is envisaged to be sold. This is by analogy with the requirement for an IFU. Note that Member States may have different language requirements for an IFU depending on whether the information is intended for health care professionals or for patients. The SSCP part intended for patients should be provided in all the languages required for IFUs intended for patients in the Member States concerned.
If the selection of European languages for the SSCP does not include English, then an English translation of the document should also be provided. English is the most common language used in medical scientific publications and is understood by many healthcare professionals in the EU. Always providing an English-language version of the SSCP further enhances access to information about devices available on the EU market.
There should be one SSCP document for each language. Each SSCP document should state in which language the SSCP was validated by the NB. The manufacturer should ensure, through their quality management system, that the translations are correct.
Other countries, such as the U.S., Canada, Australia, and Japan, have different regulatory mechanisms for clinical data and safety evaluations, but they do not specifically require an SSCP.
In most regions, clinical evaluation reports and safety performance data are mandatory, but the format and specific requirements vary.
Relevant SSCP information for patients
The MDR indicates that patients are also intended recipients of the information in the SSCP, “if relevant”. Devices for which information will be especially relevant for patients include:
- Implantable devices for which patients will be given implant cards, and
- Class III devices that are intended to be used directly by patients.
For these devices, a part of the SSCP specifically intended for patients should be provided.
Note: Devices listed in MDR Annex XVI, and eligible for a SSCP, should always be considered as relevant for patient information.
For devices other than the two groups listed above, including any devices listed in Annex XVI and eligible for a SSCP, the manufacturer may consider whether it is relevant to provide specific information intended for patients. This can be based on the manufacturer’s analysis of the device in question.
Readability
The SSCP should always have one part for intended users/healthcare professionals, and when it is relevant (see above) a second part for patients. Both should be clear and provide information at an appropriate depth to reflect the healthcare professionals’ and the patients’ different levels of knowledge.
For further guidance, see references and in this guide. It should not be assumed that the patient has any formal education in a medical discipline or any prior knowledge of medical terminology or clinical research. It is recommended that the readability of the part of the SSCP intended for patients is assessed for example by a test given to lay persons. The manufacturer may use a method it finds adequate for the readability test to confirm that the SSCP is written in a way that is clear to the patient.
Medical terminology, relevant for the medical device and the clinical context, should be used consistently throughout the part of the SSCP that is intended for healthcare professionals.
Validation and uploading of the SSCP
Validation of the initial SSCP by the NB
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.
In the circumstance that the conformity assessment is performed according to Annex X and XI in the MDR and there are two NBs involved, it is the NB which assesses the TD according to Annex X that shall validate the SSCP.
The validation of the SSCP by the NB covers only one of the language(s) accepted by the NB and agreed with the manufacturer. The manufacturer should state in the revision history in each SSCP document in which language the SSCP was validated by the NB.
The timing of the SSCP validation may depend on the class of device and the conformity assessment routes:
- For class III devices and class IIb implantable devices, except sutures and staples etc., the validation is performed when a draft SSCP as a part of the application documents is submitted to the NB involved in the conformity assessment, prior to issuing the certificate.
- For class IIa implantable and some IIb implantable devices such as sutures and staples etc., a draft SSCP as a part of the application documents shall be submitted to the NB involved in the conformity assessment. The draft SSCP shall be validated by the NB.
In the circumstance if more than one device is covered by the relevant certificate, at least one draft SSCP shall be validated against relevant documents in the TD during the initial conformity assessment, prior to issuing the certificate.
Draft SSCPs that are not validated at the initial conformity assessment, shall be validated against relevant documents in the TD at least once during the period of validity of the certificate.
Validation of updates of the SSCP between certification activities
The manufacturer has an obligation to keep the SSCP updated; for further details, see the section “General requirements and recommendations for the SSCP” in this guide. Furthermore, the manufacturer shall prepare a periodic safety update report (PSUR) that includes data gathered as a result of the post-market surveillance plan, description of any preventive and corrective actions taken, conclusions of the benefit-risk determination, and the main findings of the PMCF. If the PSUR contains information rendering any information in the SSCP incorrect or incomplete, the SSCP shall be updated to be in line with the information in the most recent PSUR.
The manufacturer shall submit a PSUR to the NB at least annually, or for class IIa implantable devices at least every two years.
If the SSCP has been updated with new/changed information, except for strictly editorial modifications, the manufacturer should submit the updated SSCP to the NB when submitting the required PSUR.
- If the SSCP has been previously validated, the NB should validate the updated SSCP against the submitted and evaluated PSUR. Both the NB and the manufacturer should make an effort to keep the validation time short in order to meet the MDR requirement of an update of the SSCP at least annually if indicated
In addition, as part of its surveillance activities, the NB shall verify that the manufacturer has appropriately updated the SSCP. The NB should take into consideration its assessment of the PMS plan and PSUR, the PMCF plan and its evaluation report, and/or other relevant information.
Validation of SSCP at certificate renewal
With each certificate renewal application, the manufacturer should:
- For class III devices and class IIb implantable devices, other than sutures and staples etc. Submit a draft SSCP which has been updated within the previous 12 months, regardless of whether there are new data or conclusions.
- For class IIa implantable and IIb implantable devices, such as sutures and staples etc. Confirm that the SSCP in Eudamed is in alignment with the current version of the TD, or provide an updated SSCP where required.
At certificate renewal, the same principles should apply for the validation of the SSCP documents as at the initial certification.
Uploading of the SSCP in Eudamed
The SSCP shall be uploaded in Eudamed by the NB, which is the only actor that can manage the SSCPs in Eudamed. Timelines for uploading of the SSCP documents in Eudamed:
- The NB shall upload the SSCP validated in conjunction with an initial conformity assessment at the same time that it uploads the issued certificate.
- For class IIa implantable and IIb implantable devices, such as sutures and staples etc, the NB shall upload the SSCPs of all the devices covered by the issued certificate at the same time that it uploads the issued certificate, even if some of the SSCPs have not been validated yet, and are to be validated during the period of validity of the certificate. The manufacturer should state in a revision history in the SSCP document whether that revision was validated by the NB. It is important and should be transparent to the public46 whether the SSCP document has been validated yet by the NB. See the example of a revision history in section 9 and in the template in the Appendix of this guide.
- The NB shall upload a SSCP whenever it has been validated against relevant documents in the TD, and thus replacing the SSCP uploaded at the initial certification with the currently validated revision.
- The manufacturer is responsible for the translations of the SSCP into other languages, once the “master” SSCP has been uploaded by the NB. If the “master” SSCP is in a language other than English, then an English translation should be provided by the manufacturer within 90 days of the upload of the “master” SSCP. The NB should upload the English translation within 15 days of receiving this from the manufacturer.
- When receiving an updated SSCP document in conjunction with the PSUR, the NB should upload the updated SSCP document within 15 days after it is validated, or within 15 days after deeming the validation to be deferred until a validation against the relevant documents in the TD is planned during the period of validity of the certificate.
- At certificate renewal, the NB shall upload any updated SSCPs of all the devices covered by the reissued certificate at the same time that it uploads the reissued certificate. The NB should ensure the revision history indicates whether or not these have been validated by the NB.
- The manufacturer should provide updated translations to the NB within 90 days of the upload of the updated “master” SSCP. The NB should upload these translations within 15 days of receiving them from the manufacturer.
Guidance for each of the required sections of the SSCP document
1. The identification of the device and the manufacturer, including the Basic UDI-DI and, if already issued, the SRN
The first section of the SSCP shall identify the device and the manufacturer, and should also contain some general information related to the device:
1.1. Device trade name(s) (this include all trade names the device may have on the market in different Member States)
1.2. Manufacturer’s name and address
1.3. Manufacturer’s SRN (single registration number)
1.4. Basic UDI-DI
1.5. Medical device nomenclature description / text
1.6. Class of device
1.7. Year when the first certificate (CE) was issued covering the device
1.8. Authorized representative if applicable; name and the SRN
1.9. NB’s name (the NB that will validate the SSCP) and the NB’s single identification number
2. The intended purpose of the device and any indications, contraindications and target populations
2.1. The device’s intended purpose(s) shall be described.
2.2. The indications shall be described. This includes the stages and/or severities of the pathologies, the specific medical conditions, and the specific anatomical locations or confirmation that no anatomical locations are contraindicated, as applicable. The target population(s) shall be specified, for example if the device is intended for adults and/or children and/or infants/neonates.
2.3. Any contraindications or restrictions for use or limitations of the device shall be included.
The information can be sourced from the IFU, or from the clinical evaluation report.
3. A description of the device, including a reference to previous generation(s) or variants if such exist, and a description of the differences, as well as, where relevant, a description of any accessories, other devices and products, which are intended to be used in combination with the device
3.1.A description of the device shall be presented, including its operating principles and mode(s) of action. Design characteristics should be included, for example key functional elements and any materials or substances in contact with the patient’s tissues. Include information on whether the device is for single use, and its method of sterilization. For absorbable implants the stability retention profile, including time to loss of stability and the absorption time, should be provided.
A picture or drawing can be added accompanied by text.
Information about the constituents should be provided, as required for the IFU, if the device incorporates
- A medicinal substance (including a human blood or plasma derivative), or
- Tissue(s) or cells of human or animal origin, or their derivatives, or
- Substances or combinations of substances that are absorbed by or locally dispersed in the human body, or
- Materials incorporated into the device that contain or consist of CMR (carcinogenic, mutagenic or toxic to reproduction) substances or endocrine-disrupting substances, or
- Materials that could result in sensitization or an allergic reaction by the patient or user.
In Eudamed, the SSCP is associated to one or multiple Basic UDI-DI(s). All UDI-DIs/devices associated to this Basic UDI-DI will be seen as having the same SSCP (a UDI-DI/device must always be associated with one and only one Basic UDI-DI).
If the device is a system of several components/devices, each device in the system should have a Basic UDI-DI but also one Basic UDI-DI for the system. It is the Basic UDI-DI for the system that is intended to be provided in section 1.4 in the template, and that will be associated with the SSCP in Eudamed. The device system, and any Basic UDI-DIs of included devices, should be described in section 3.1
The device description in the SSCP shall therefore include all the device(s)/device system associated with the same Basic UDI-DI. The description of the device(s)/device system should be comprehensive and can be presented in different ways to include, if such exist, any configurations / combinations / different sizes / specification of any soft-ware versions that can be related to safety and/or performance and their release dates / etc. The description should also include any model number or similar designation used to identify the device(s)/device system.
3.2.A reference to previous generation(s) or variants shall be provided, if such exist. This applies both to changes/variants of the device itself (same Basic UDI-DI) and to previous generation(s) or variants associated with other Basic UDI-DIs, if available. A description of the differences shall be provided, highlighting the reasons for the change; for example, changes to the intended clinical benefits, changes to reduce identified clinical risks, or changes for manufacturing reasons etc.
In the part of the SSCP that is intended for patients, section 3 may be limited to the device(s) in question (Basic UDI-DI) including relevant and necessary accessories from a patient’s perspective; see suggested headings for section 3 in the template in the Appendix.
4. Information on any residual risks and any undesirable effects, warnings and precautions
4.1. Residual risks and undesirable effects
This section of the SSCP guide and template includes residual risks, other than those contraindications, limitations, warnings and precautions that are included in sections 2.3 and 4.2.
Description of residual risks and undesirable effects
Risk is defined in the MDR as the combination of the probability of occurrence of harm and the severity of that harm. Harm is defined in the standard ISO 14971:201257 as physical injury or damage to the health of people, or damage to property or the environment. Thus the term ‘risk’ includes both clinical and non-clinical harms.
The term ‘residual risk’ is defined in the standard ISO 14971:201258 as “risk remaining after risk control measures have been taken”.
There is a requirement in the MDR that the IFU shall contain information on any residual risks and any undesirable side-effects, i.e. no sort of residual risk or undesirable side-effect related to the device is excluded from disclosure. The SSCP should contain information on at least the same residual risks and undesirable side-effects as included in the IFU.
For example, some events indicated in the MDR by the terms ‘adverse events’, ‘undesirable side-effects’ or ‘incidents’, may all be annotated as ‘adverse events’ in the scientific literature.
Any further discussion on risks can be included in the SSCP if needed for clarity or comprehension.
Quantitative data
The definition of risk includes the probability of occurrence of harm. Therefore, the information in the SSCP on risks shall also include quantifications. This information can be sourced from the clinical evaluation report where an updated examination of qualitative and quantitative aspects of clinical safety is available, with clear reference to the determination of residual risks and side-effects.
To use tabulated lists for the presentation of side-effects and residual risks with quantitative data and a relation to time, may enhance the readability.
In the part of the SSCP that is intended for patients, residual risks and side effects should be explained and quantified in a way that patients and lay persons can understand. A statement should be included about how potential risks have been controlled or managed, and also a statement on what to do if the patient believes that he/she is experiencing side-effects related to the device or its use. See the example in the template in the Appendix.
4.2. All warnings and precautions pertaining to the device should be presented. However, warnings and precautions solely related to for example installation/preparation of a device or relating to special procedural steps can be discussed on a general level in the SSCP if a link (URL) to the IFU on the manufacturer’s website is provided.
Always include any warnings, precautions or measures to be taken by the patient or a healthcare professional with regard to reciprocal interference with reasonably foreseeable external influences, medical examinations or environmental conditions.
If any particular clinical follow-up is necessary and mentioned in the IFU, that information should also be included in the SSCP.
4.3. Other relevant aspects of safety should be described. If the device has been subject to any field safety corrective action (FSCA including FSN), the date of the FSCA and a summary of the associated circumstances and any actions undertaken should also be included.
5. Possible diagnostic or therapeutic alternatives
This part of the SSCP document should contain a review of how the device relates, in terms of benefit-risk, to diagnostic or therapeutic alternatives and the specific conditions under which the device and its alternatives can be considered.
If reference is made to the “state of the art”, that statement should be supported for example by referring to relevant recognized guidance documents generated by specialty medical societies or educational bodies.
In the part of the SSCP intended for patients the text should include a recommendation to discuss any possible diagnostic or therapeutic alternatives with a healthcare professional who can take into consideration the individual patient’s situation. See the proposed text in the template in the Appendix
6. Suggested profile and training for users
The experience, education and/or training of the intended user(s) shall be described. This includes any specific mandatory training before using the device, and any update training for continued safe use of the device.
If the device is intended to be handled directly by the patient, section 7 should be included in the SSCP part intended for patients and any required training should be described.
