Post-market surveillance reporting requirements are different depending on the classification of the devices the PMS system is covering. This article provides an overview of PMS reporting according to medical device classification.
For class I devices, the manufacturers shall set up a PMS report summarising the results and conclusions of the analyses of the post-market surveillance data. This is gathered as a result of the PMS plan, together with a rationale and description of any preventive and corrective actions taken.
This report shall be updated by the manufacturer when necessary and made available to the competent authority upon request.
For class IIa devices, the manufacturer must set up a periodic safety update report, a PSUR. This is the PMS report for manufacturers of class IIa, IIb and III devices.
| Medical device class | Report | Update frequency | Make available to notified body |
|---|---|---|---|
|
Class I
|
PMS report
|
Updated as necessary
|
|
|
Class IIa
|
PSUR
|
Updated as necessary but at least every second year
|
Yes
|
|
Class IIb and III
|
PSUR
|
Updated as necessary but at least annually
|
Yes
|
|
Class III and implantable devices
|
PSUR
|
Uploaded to EUDAMED for notified body assessment
|
|
The PSUR shall, as well as the PMS report required for class I devices, summarise the results and conclusions of the analyses of the PMS data gathered according to the PMS plan together with a rationale and description of any preventive and corrective actions taken.
The PSUR shall also include (not for class I devices):
(a) the conclusions of the benefit-risk determination;
(b) the main findings of the PMCF; and
(c) the volume of sales of the device and an estimate evaluation of the size and other characteristics of the population using the device and, where practicable, the usage frequency of the device.
For class IIa devices, the PSUR shall be updated when necessary, but at least every two years.
For class IIb and III devices, this PSUR shall be updated as necessary but at least annually.
For class IIa and IIb, the PSUR shall also be made available to the notified body.
How to make the PSUR available to the notified body is not stipulated in the MDR, so this is something that the notified body of the manufacturer should state in its agreements.
If the manufacturer creates implantable devices or class III devices, the PSUR shall be uploaded to EUDAMED for notified body assessment. The notified body, in turn, needs to upload its conclusions of the assessment to EUDAMED. This notified body assessment is not publicly available but only available for competent authorities.
If you want to know more about understanding the European regulation for medical devices, take a look at our online Introduction to the Medical Device Regulation (EU) 2017/745 course. This online course is an in-depth overview of the Medical Device Regulation according to (EU) 2017/745 as well as related guidances, like MDCG, and how to apply to a notified body for conformity assessment.
It is suitable for anyone working with regulatory questions, such as RA and QA engineers, PRRC or management.
Pontus Gedda is a dedicated medical device specialist that has worked both in the industry, as a design engineer and project manager, and in the notified body world as a medical device lead auditor and manager.
He has vast experience in the MDR and its implementation thru hands-on experience from implementing the MDR at a notified body and leading that notified body through a joint assessment and getting designated as an MDR notified body.
He was a senior manager at a notified body during the transition from MDD to MDR and also a member of the NB-MED group.
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