Date : 22/10/19
SUBJECT: 2019-09 – Guide relating to the “Summary of Safety and Clinical Performance” (SSCP) – Manufacturers’ Guide – August 19
PERSONS CONCERNED: Regulatory Affairs and Quality Managers
COMPANIES CONCERNED: Medical Device and In-Vitro Diagnostic Medical Device Companies
MDR 2017/745 (article 32) states that manufacturer must produce a Summary of Safety and Clinical Performance (SSCP) for implantable devices and Class III devices other than customised devices or those under investigation.
The SSCP must be validated by the Notified Body, which must then proceed to download it onto the “EUDAMED” European database (when it goes live in May 2022).
The SSCP is intended to provide public access to the updated clinical data summary and other information relating to the safety and clinical performance of the medical device and will constitute an important source of information for target users (Health Professionals and Patients).
It is a way to meet MDR objectives -> enhance transparency and provide appropriate access to information.
The main aim of this document is to provide recommendations on the presentation, content and validation of the SSCP.
SUMMARY OF SAFETY AND CLINICAL PERFORMANCE
This Summary of Safety and Clinical Performance (SSCP) is intended to provide public access to an updated summary of the main aspects of the safety and clinical performance of the device.
This SSCP is not intended to replace the Instructions for Use as the main document ensuring the safe use of the device or to provide recommendations in terms of diagnosis or treatment for target users or patients. The following information is intended for users / health professionals.
If the SSCP includes a part intended for patients, the following phrase can be added:
Following this information, a summary dedicated to patients is also included.
- Device identification and general information:
- Commercial name of the device,
- Manufacturer’s name and address,
- Manufacturer’s single registration number (SRN),
- Basic UDI (Unique Device Identification),
- Description / text of the medical device nomenclature,
- Device class,
- First EC certificate issue year covering the device,
- Agent, if applicable (name and SRN),
- Name of the NB (Notified Body) (that will validate the SSCP) and the single identification number of the NB.
- Device purpose:
- Intended purpose,
- Instructions and target population(s),
- Contraindications and / or restrictions.
- Device description:
- Device description,
- Reference to the previous generations or versions, if applicable, and a description of the differences,
- A description of all accessories intended to be used in combination with the device,
- A description of any other device or product intended to be used in combination with the device.
- Risks and warnings:
- Residual risks and adverse effects,
- Warnings and precautions,
- Other important safety aspects, including a summary of any Corrective Safety Action (FSCA (Field Safety Corrective Action) including the FSN (Field Safety Notice)), if applicable.
- Summary of the clinical evaluation and post-market clinical follow-up (PMCF):
- Summary of the clinical data relating to the equivalent device, if applicable,
- Summary of the clinical data resulting from investigations carried out on the device prior to CE marking, if applicable,
- Summary of the clinical data from other sources, if applicable,
- General summary of the clinical and safety performance,
- Post-market clinical follow-up in progress or planned.
- Possible diagnostic or therapeutic solutions.
- Suggested profile and training for users.
- Reference to the harmonised standards and common specifications (CS) applied.
- Review history
|SSCP review number||Issue date||Description of change(s)||Review validated by the Notified Body|
Validation language :
🞎No (Only applicable to Class IIa and certain Class IIb implantable devices (MDR Article 52 (4) 2nd paragraph) for which the SSCP is not yet validated by the NB)
Validation languagee :