Last updated: 14 January 2022
See update(s) at the end of the post.
The Medical Devices Regulation (EU) 2017/745 (MDR) requires require manufacturers to draw up a Summary of Safety and Clinical Performance (SSCP) for their devices. This post attempts to provide the basics of this requirement.
Where in the MDR can you find information on the Summary of Safety and Clinical Performance (SSCP)?
Information on the SSCP is available in the MDR Article 32.
Which devices require a SSCP?
Manufacturers are required to draw up a SSCP for:
- Implantable devices
- Class III devices
Investigational and custom-made devices are excluded from this requirement.
What is the role of a SSCP?
It is:
- intended to provide public access to an updated summary of clinical data and other information about the safety and clinical performance of a medical device
- an important source of information for both healthcare professionals and IF relevant, for patients.
Its objective is to enhance transparency and provide adequate access to information about a medical device.
What is the SSCP not intended for?
The SSCP is NOT intended to:
- give general advice on the diagnosis or treatment of particular conditions.
- replace the Instructions for Use (IFU) that normally accompanies a medical device.
- replace the mandatory information on implant cards or other mandatory documents.
Where is the information in a SSCP sourced from?
According to the Medical Device Coordination Group guidance MDCG 2019-9 Rev.1, the information in the SSCP should be sourced entirely from the Technical Documentation (TD) of the device. Examples of the technical documents from which information can be extracted include:
- Design verification/validation reports
- The risk management report/file
- The Clinical Evaluation Report (CER)
- Post Market Surveillance (PMS) plans/reports
- Post Market Clinical Follow-up (PMCF) plans/reports
- The Instructions for Use (IFU) if appropriate
How does a Notified Body (NB) deal with an SSCP?
- The draft of the SSCP is included in the documentation to be submitted to the NB involved in the conformity assessment.
- The NB validates the SSCP.
- Once validated, the NB uploads the summary to Eudamed (see below)
It is also important to note that the NB does not validate versions of the SSCP translated into other EU languages but shall upload them to Eudamend within 15 days of receiving them.
Where will an SSCP be stored once it has been validated so that it can be made available to users, including the public?
It shall be kept updated in Eudamed when the latter is ready and in production.
How will it be possible to find the exact location of an SSCP in Eudamed?
The IFU of a device or its label shall contain adequate information to be able to find the SSCP in Eudamed.
How frequently should an SSCP be updated?
- At least once a year when the post-market clinical follow-up (PMCF) and Periodic Safety Update Report (PSUR) are updated, the SSCP should also be reviewed and updated if needed. This ensures that all clinical and or safety information in the SSCP is correct, complete and up to date.
- When updating a SSCP it may be necessary to update all its sections in order to align it with the current version of the relevant parts of the Technical Documentation of the device.
The SSCP shall be objective and adequately summarise both favourable and unfavourable data on the device.
In the SSCP, is there information for healthcare professions and/or patients?
- MDCG 2019-9 Rev.1 states that the SSCP should always have one part for intended users/healthcare professionals, and when it is relevant, a second part for patients.
Devices for which information will be especially relevant for patients include:
- implantable devices for which patients will be given implant cards
- 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.
Is there a requirement for the SSCP to be prepared in a particular European language?
- In the MDR, there is a requirement that the SSCP shall be written in a manner that is clear to the intended user including the patient (if relevant). to meet this requirement, the SSCP should be translated into the languages accepted in the Member States where the device is likely to be sold.
- The SSCP part intended for patients should be provided in all of 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 as it is the most common language used in medical and scientific publications and widely spoken by EU healthcare professionals.
- There should be an SSCP for each language.
- Each SSCP should state the language of validation of the SSCP by the Notified Body.
What are the required sections of the SSCP?
It is important to note that the SSCP should be presented in an organised and unambiguous manner. The SSCP shall include at least the following aspects:
- The identification of the device and the manufacturer, including the Basic UDI-DI and, if already issued, 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 generation(s) or variants if such exist, and a description of the differences. Where relevant, a description of any accessories, other devices and products, which are intended to be used in combination with the device should be included.
- Possible diagnostic or therapeutic alternatives
- Reference to any harmonised standards and Common Specifications (CS) applied
- The summary of clinical evaluation as referred to in Annex XIV, and relevant information on post-market clinical follow-up (PMCF).
- Suggested profile and training for users
- Information on any residual risks and any undesirable effects, warnings and precautions
The guidance MDCG 2019-9 Rev.1 also includes a one further aspect in addition to the eight above i.e. revision history. It states that the SSCP should include a revision history.
More detailed information on each of the above aspects is available in the guidance.
Is there any other information that should be added to the SSCP?
As stated in MDCG 2019-9 Rev.1 , the manufacturer may add further information from the Technical Documentation 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.
Sources:
Medical Devices Regulation (EU) 2017/745
MDCG 2019-9 Rev.1 Summary of safety and clinical performance A guide for manufacturers and notified bodies – March 2022
Updates
| Date | Update |
|---|---|
| 14 Jan 2022 | Links to MDCG 2019-9 (August 2019)updated to MDCG 2019-9 Rev 1 March 2022 |