Regulation (EU) 2017/745 also known as the MDR, applicable since May 26th 2021, introduced a new obligation for the medical device manufacturers – according to the Article 86, they are obliged to prepare the medical device Periodic Safety Update Report (PSUR) for medical device classes of risk IIa, IIb and III.
As the MDR has significantly increased the requirements for monitoring products, we asked our vigilance experts to look into the new obligations for PSUR creation. Continue reading to discover the details of the new medical device PSUR requirements.
Which medical device class of risk requires the PSUR?
The rules on the classification of the medical device are listed and clearly explained in the Annex VIII of the Regulation (EU) 2017/745.
Table 1: Classes of medical device risk as per Regulation (EU) 2017/745
- Class of Risk I:
- manufacturers are not required to write PSUR
- shall prepare a Post-Market Surveillance Report (PMSR) summarising the results and conclusions of the analyses of the post-market surveillance data gathered as a result of the post-market surveillance plan together with a rationale and description of any preventive and corrective actions taken
- the report shall be updated when necessary and made available to the competent authority upon request.
- Class of Risk IIa, IIb, III:
- Required to produce PSUR for their products due to the major associated risks
In the next sections of this article, we will explore the PSUR requirements for the medical devices of the class of risk IIa, IIb and III.
What are the transitional measures for medical device PSUR submission until Eudamed will be fully functional?
Formally, the MDR is fully applicable since the 26th of May 2021. However, since EUDAMED is not yet completely implemented, a transitional period is allowed.
Medical device coordination group (MDCG) 2021-1 Rev. 1 of May 2021 indicated the following transitional solution for PSUR submission:
“For class III devices and for classes IIa, and IIb implantable devices, manufacturers should deliver the PSURs to the relevant notified bodies by appropriate means.”
“Notified bodies should provide the PSURs and corresponding evaluations to the manufacturers and make them available upon request to the competent authority.”
Table 2. Source: MDCG 2021-1 Rev.1
What are the MDR rules that take immediate effect?
The following obligations regarding the PSUR submission are already applicable according to the Article 86 of the Regulation (EU) 2017/745:
“The medical device PSUR should summarise 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 84 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:
The conclusions of the benefit-risk determination
According to the Article 83 of the MDR, the manufacturer shall plan, establish, document, implement, maintain and update a post-market surveillance system in a manner that is proportionate to the risk class and appropriate for the type of device.
One of the scopes of the manufacturer’s post-market surveillance system is to update the benefit-risk determination and, according to EN ISO 14971, to improve the risk management.
At the end of the risk management activities flow and, according to the information from post-market surveillance, the manufacturer prepares a Risk Management Report, evaluates the benefits and the risks identified for the medical device and writes the conclusions of the benefit-risk determination.
The main findings of the Post Market Clinical Follow-up (PMCF)
According to the Annex XIV part B of the Regulation (EU) 2017/745, PMCF shall be understood to be a continuous process that updates the clinical evaluation referred to in Article 61 and Part A of the Annex XIV and shall be addressed in the manufacturer’s post-market surveillance plan.
When conducting PMCF, the manufacturer shall proactively collect and evaluate clinical data from the use in or on humans of a device which bears the CE marking and is placed on the market or put into service within its intended purpose as referred to in the relevant conformity assessment procedure, with the aim of confirming the safety and performance throughout the expected lifetime of the device, of ensuring the continued acceptability of identified risks and of detecting emerging risks on the basis of factual evidence.
The volume of sales of the device and an estimate evaluation of the size and other characteristics of the population using the device & where practicable, the usage frequency of the device
The above last two points have the scope to estimate a denominator in order to calculate the frequency of the adverse events and of the incidents.
The frequency of update of PSUR
Manufacturers of class IIb and class III devices shall update the PSUR at least annually. Manufacturers of class IIa devices shall update the PSUR when necessary and at least every two years.
Table 3: Frequency of the PSUR update according to Regulation (EU) 2017/745