In order to meet MDR requirements and demonstrate product conformity, manufacturers must prepare the reports listed below periodically and ensure that they are up-to-date.
- Clinical Data Evaluation Report (CER - Clinical Evaluation Report)
- Post-Market Clinical Follow-up Report (PMCF - Evaluation Report)
- Post-Market Surveillance Report (PMSR)
- Periodic Safety Update Report (PSUR - Periodic Safety Update Report)
- Summary of Safety and Clinical Performance (SSCP - Summary of Safety and Clinical Performance)
Clinical Evaluation Report (CER):
According to article 61 (11) of MDR (2017/745), clinical evaluation and documentation shall be carried out throughout the life cycle of the relevant device, in accordance with Article XIV. It is updated throughout the life cycle of the device in question with clinical data obtained from the implementation of the manufacturer's PMCF plan in accordance with Part B of Annex and the post-market surveillance plan referred to in Annex 84.
For all product classes (Class I, IIa, IIb and III), what is expected from us is to evaluate and report our Clinical Data and to keep our data up to date. The Clinical Data Evaluation Report (CER) is a report that must be prepared for all product classes and the frequency of updates will vary depending on the risk and configuration level of the product.
Our recommendation is that the update frequency should be at most 2 years.
Post-market Clinical Follow-up Report (PMCF):
In accordance with MDR Annex XIV Part B (7), the Manufacturer analyzes the findings of the PMCF and documents the results in the PMCF evaluation report, which is part of the clinical evaluation report and technical documentation.
We would like to say that this type of reporting will often remind us that clinical data is an integral part of our lives. Post-market Clinical Follow-up (PMCF) Report is prepared for all product classes (Class I, IIa, IIb and III). In cases where it is not necessary, a justification must be made.
Post-Market Surveillance Report (PMSR):
Manufacturers of Class I devices in accordance with Article 85 MDR must submit a statement to the market summarizing the results of the analysis of post-market surveillance data collected as a result of the post-market surveillance plan referred to in Article 84 and the outputs based on these results, together with a justification and description of each preventive and corrective action taken. Prepares post-surveillance report. This report is updated when necessary and provided to the competent authority upon request.
A Post Market Surveillance Report (PMSR) is not required for class IIa, class IIb, class III devices. Results for products belonging to these risk classes are presented in the Periodic Safety Update Report (PSUR).
Periodic Safety Update Report (PSUR):
In accordance with MDR Article 85; Manufacturers of class IIa, class IIb and class III devices shall, for each device and, where relevant, each category or group of devices, as a result of the post-market surveillance plan referred to in Article 84, together with the justification and description of each preventive and corrective action taken. prepares a periodic safety update report (“PSUR”) summarizing the results of the analysis of the post-market surveillance data collected and the outputs based on these results.
Summary of Safety and Clinical Performance (SSCP - Summary of Safety and Clinical Performance):
In accordance with Article 32 of the MDR, excluding devices manufactured to order or for research purposes; For implantable devices and class III devices, the manufacturer prepares a Summary of Safety and Clinical Performance.
The Summary of Safety and Clinical Performance is written in a manner that is understandable to the intended user and, if relevant, the patient, and is publicly available through Eudamed.
The draft summary of safety and clinical performance is part of the documentation to be submitted to, and validated by, the notified body involved in the conformity assessment in accordance with Article 52. After the approved body validates the summary, it uploads it to Eudamed. The manufacturer indicates the location of the summary on the label or user manual.
The Summary of Safety and Clinical Performance (SSCP) should be designed to create an accurate understanding of the risks and benefits of medical devices for both healthcare professionals and patients. The Summary of Safety and Clinical Performance (SSCP) should be kept up to date in EUDAMED, the PMCF evaluation report and the Periodic Safety Update Report (PSUR) should be updated at least annually to ensure that clinical and/or safety information is accurate and complete. The summary (SSCP) should be reviewed and updated if necessary.
Click to download the information brochure, which you can see by going to the relevant table for each risk class regarding activities requiring notification.
