We have dedicated “Medical Writing Team” with extensive experience in authoring SSCP, PSUR PER, CER and literature search reports.
The team has successfully supported and delivered SSCP, PSUR, PER, CER and literature search projects for multiple companies with utmost quality meeting regulatory requirements.
Summary of Safety and Clinical Performance (SSCP)
Summary of Safety and
Clinical Performance (SSCP)
Summary of Safety and Clinical Performance (SSCP)
Current Challnges Related to PR
Shortfall of expertise in authoring and updating Summary of Safety and Clinical Performance (SSCP)
Effective planning to compile and submit the SSCP’s to Notified bodies meeting regulatory requirements
Scarcity of qualified writers and evaluators with profound knowledge on In Vitro diagnostic devices
Client management to adhere to timelines meeting regulatory changes
Artixio's Expertise
In the case of devices classified as class III and implantable devices, the manufacturer shall draw up a summary of safety and clinical performance.
It shall be written in a way that is clear to the intended user and, if relevant, to the patient and shall be available to the public via EUDAMED.
The draft of this summary shall be submitted to the notified body and shall be validated by that body. After validation the notified body shall upload this summary report to Eudamed. The manufacturer shall mention on the label or instructions for use where the summary report is available.
SSCP Authoring
Updates
Gap Analysis & Submission to NB
Authoring SSCP Medical devices and IVDs
SSCP for Patient
SSCP for HCP
Translation
Annual updates for class III and implantable devices Medical Devices
Annual updates for Class C and D IVDs
Gap assessment of existing SSCP for compliance to MDR and IVDR
Follow up with NB Address Gaps
Article 32 - Summary of Safety and Clinical Performance (SSCP)
In the case of devices classified as class III and implantable devices, the manufacturer shall draw up a summary of safety and clinical performance.
It shall be written in a way that is clear to the intended user and, if relevant, to the patient and shall be available to the public via EUDAMED.
The draft of this summary shall be submitted to the notified body and shall be validated by that body. After validation the notified body shall upload this summary report to Eudamed. The manufacturer shall mention on the label or instructions for use where the summary report is available.
Article 49 – Clinical Evaluation
For devices classified as class III and implantable devices, the PMCF report and, if indicated, the summary of safety and clinical performance shall be updated at least annually with these data.
Format of SSCP
Manufacturer + SRN
Device + UDI
Intended Purpose, Indications, Contra-indications
Description, previous variant(s), differences, accessories, other products intended to be used in combination
Possible diagnostic or therapeutic alternatives
Harmonised Standards / Common Specifications
Summary of the Clinical Evaluation Report + PMCF
Suggested profile and training for users
Information on residual risks, undesirable effects, warnings & precautions
SSCP – two versions in some cases
Art. 32(1) requires SSCP SHALL be written in a way that is clear to the intended user and, if relevant, to the patient
This implies a different literacy levels when intended for healthcare professionals (HCP) and patients, respectively
Hence TWO versions of SSCP!
One for HCP
One for patients!
Language requirements - SSCP
The version of the SSCP uploaded to Eudamed should be:
Protected against modification;
Readily searchable (when downloaded);
Readily printable (when downloaded).
SSCP should be TRANSLATED into the languages of all MS where it is envisaged device will be sold (similar to IFU);
Version for the patient, one language per document!
SSCP for Patient
Written in clear, concise language
Medical terms should be explain in simple language
12 point font
Written at level 2-3 in International Adult Literacy Survey
Somewhere between “understandable by a 12yo” and “high school completion” level
Summary of Safety &
Clinical Performance SSCP in Vitro Diagnostic Devices
Updates throughout the life cycle of the device with data obtained by post market follow-up according to respective plan
Periodic Safety Update Report acc. to Article 58c when necessary, at least annually for class C and D
Summary of Safety and Performance Report (Article 24) to be updated soon as possible (class C and D)
Post-market surveillance report for class A and B acc. to Article 58ba when necessary
Getting it to Eudamed
Submit SSCP as part of packet of info to NB for Conformity Assessment
Once they have issued the CE certificate, NB upload to Eudamed WITHIN 30 DAYS
NB will validate the SSCP submitted meets all requirements of Art 32 (content) and is consistent with TD submitted
NB will validate BOTH the version for HCP and PATIENTS
Somewhere between “understandable by a 12yo” and “high school completion” level
SSCP as per IVDR
For class C and D devices, other than devices for performance studies, the manufacturer shall draw up a summary of safety and performance. The summary of safety and performance shall be written in a way that is clear to the intended user and, if relevant, to the patient and shall be made available to the public via Eudamed. The draft of the summary of safety and performance shall be part of the documentation to be submitted to the notified body involved in the conformity assessment pursuant to Article 48 and shall be validated by that body. After its validation, the notified body shall upload the summary to Eudamed. The manufacturer shall mention on the label or instructions for use where the summary is available.
The summary of safety and performance shall include at least the following aspects:
(a) the identification of the device and the manufacturer, including the Basic UDI-DI and, if already issued, the SRN;
(b) the intended purpose of the device and any indications, contra-indications and target populations;
(c) 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;
(d) reference to any harmonised standards and CS applied;
(e) the summary of the performance evaluation as referred to in Annex XIII, and relevant information on the PMPF;
(f) the metrological traceability of assigned values;
(g) suggested profile and training for users;
(h) information on any residual risks and any undesirable effects, warnings and precautions.
The Commission may, by means of implementing acts, set out the form and the presentation of the data elements to be included in the summary of safety and performance. Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 107(2).
PSUR Requirements
Manufacturers of class C and class D devices shall prepare a periodic safety update report (‘PSUR’) for each device and where relevant for each category or group of devices summarising the results and conclusions of the analyses of the post-market surveillance data gathered as a result of the post-market surveillance plan referred to in Article 79 together with a rationale and description of any preventive and corrective actions taken. Throughout the lifetime of the device concerned, that PSUR shall set out:
(a) the conclusions of the benefit-risk determination;
(b) the main findings of the PMPF; and
(c) the volume of sales of the device and an estimate of the size and other characteristics of the population using the device and, where practicable, the usage frequency of the device. Manufacturers of class C and D devices shall update the PSUR at least annually. That PSUR shall be part of the technical documentation as specified in Annexes II and III.
Manufacturers of class D devices shall submit PSUR by means of the electronic system referred to in Article 87 to the notified body involved in the conformity assessment of such devices in accordance with Article 48. The notified body shall review the report and add its evaluation to that electronic system with details of any action taken. Such PSUR and the evaluation by the notified body shall be made available to competent authorities through that electronic system.
For class C devices, manufacturers shall make PSURs available to the notified body involved in the conformity assessment and, upon request, to competent authorities.
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