The MDR Article 2 point 60 explains post-market surveillance as a proactive and organized process which manufacturers applies and perform (with other economic operators) so as to take corrective and preventive action (CAPA) consistent with information on medical devices and relevant performance metrics. The surveillance and reporting of incidents concerning medical devices permits documentation of problems with the design, production or utilization of medical devices and, eventually, improves patient safety.
The objective of the post-market surveillance system is to vigorously and systematically collect, record and reviews pertinent statistics on the quality, performance and safety of a device during its complete period. This permits manufacturers to uninterruptedly bring up-to-date the risk-benefit assessment and to lead obligatory measures without interruption. Manufacturers are directed to gather and evaluate all information about their medical devices and associated devices from competitors. Post-market surveillance, vigilance and market surveillance requirements of the MDR will be enforced after the date of its enforcement which is 26th May 2020.
Post-market surveillance (PMS)
Comparison between Post-market surveillance and Vigilance
Vigilance is merely one component of the post-market surveillance system, as it discusses the communication of high risk incidents, recalls and field safety corrective actions (FSCAs). It is a sensitive system that manages incidents, instead of the proactive gathering of PMS data. MDR Chapter VII Section 2 of the MDR on vigilance describes the incidents that producers have to report to the pertinent competent authorities and how to defer to these reports. Similarly, it necessitates manufacturers to analyze their vigilance data. Other guidance concerning the vigilance system presently in operation under the MDD (to balance the MEDDEV 2.12-1 rev 8 from 2013) was issued in July 2019. This text discusses the new manufacturer’s incident report form, which by now contains the , UDI (Unique Device Identification), IMDRF adverse incident vocabulary and the single registration number as given in the MDR.
Manufacturers’ post-market surveillance responsibilities
The conformity assessment proceedings for acquiring a CE mark, as drawn in Annexes IX to XI, need that manufacturers develop and keep a post-market surveillance process that is equivalent to the risk class and the nature of the device. This surely explains, post-market surveillance is needed irrespective of the classification of the medical device, but the particulars of the requirements vary.
Manufacturers and producers of medical devices in Europe have to found their post-market surveillance system and mechanism on a post-market surveillance plan (as per Article 84), which is component of the technical documentation and demonstrates compliance with the PMS needs of the MDR. Annex III stipulates the necessities and the material of a post-market surveillance proposal, which has to discourse the gathering and use of the post-market information and encompass as a minimum of following:
- A proactive and efficient process to gather any information needed The process shall permit a correct characterization of the performance of the devices and will also permit a judgement to be performed between the device and similar products accessible on the market.
- Operative and suitable methods and processes to evaluate the collected data
- Appropriate indicators and threshold values that shall be utilized in the constant reconsideration of the benefit-risk analysis and of the risk management as mentioned to in Section 3 of Annex I
- Efficient and suitable methods and tools to examine complaints and analyze market-oriented experience gathered in the field.
- Approaches and procedures to handle the events subject to the trend report as given in Article 88, as well as the methods and protocols to be utilized to develop any statistically noteworthy rise in the occurrence or severity of incidents along with the observation period.
- Approaches and procedures to communicate efficiently with notified bodies, economic operators, competent authorities and users.
- Stipulate reference to procedures to comply with the manufacturer’s obligations stated in Articles 83, 84 and 86.
- Organized procedures to recognize and initiate suitable actions including corrective actions.
- Efficient tools to trace and recognize devices for which corrective actions might be compulsory.
- Plan for Post-Market Clinical Follow-up (PMCF) as stated to in Part B of Annex XIV, or an explanation as to why a PMCF is not needed.
Post-market surveillance requirements for medical devices
Post-market surveillance is needed irrespective of the classification of the medical device, but the particulars of the requirements differ with different classes.
Elements of a Post-market surveillance report
Manufacturers of Class I medical devices (along with classes Is, Im and Ir) are needed to formulate a post-market surveillance report to review the results and conclusions of the data collected as explicated in the PMS plan. The report incorporates the foundation behind and the account of preventive and corrective actions that have been made; and it has to be structured when compulsory.
Elements of Periodic Safety Update Report (PSUR)
A Periodic Safety Update Report is needed from producers of class IIA, class IIB and class III devices. In this account, the outcomes and conclusions of the examination of the PMS data have to be briefed and preventive along with corrective actions have to be explained. The PSUR has to incorporate the outcomes of the benefit-risk resolution, the core conclusions of the post-market clinical follow-up, and the capacity of sales of the device together with statistics on the population utilizing the device.
The PSUR is component of the technical report and documentation and has to be modified repeatedly: as a minimum of every two years for class IIA devices and yearly for class IIB and class III devices.
The PSUR of class III devices has to be reported via the electronic system on vigilance and post-market surveillance mentioned to in Article 92 to the notified body. The notified body enhances its assessment to the report and both documents will be provided to competent authorities via the electronic system. Manufacturers and producers of implantable devices and class III devices are similarly needed to utilize PMS data to modify and update their summary of safety and clinical performance as described in Article 32.
Manufacturers have to prepare PSURs of class IIA and class IIB devices accessible to their notified bodies and, on need, to competent authorities.
The Need of PMCF (Post Market Clinical Follow-up)
PMCF (Post Market Clinical Follow-up) is also a part of PMS. To learn more about PMCF, read about the comprehensive blog on PMCF.
PMS requirements required by appropriate Quality Management System (QMS) and risk management standards
The ISO standards for quality management and risk management also acknowledge the idea of PMS; moreover. Article 83 of the MDR explains that the post-market surveillance system is an integral component of the manufacturer’s QMS.
To confirm the efficiency of the QMS and the safety of medical devices, ISO 13485 necessitates a methodical post-market surveillance. Clause 8 describes the necessities for a constant procedure for feedback dispensation which incorporates the data from production and post-production activities. Information collected in the feedback procedure has to be taken as input for risk management.
ISO 14971 necessities in the post-market stage do not emphasize on reporting responsibilities but intent to allow for PMS data to analyze if the likelihoods and severity of possible damage are properly valued, the risks are fully recognized and if the supposed risk acceptance criteria and benefit–risk ratios are effective.
In contrast with the MDR, the simple PMS requirements forced by ISO 13485:2016 and ISO 14971:2012 are already compulsory, as the standards are synchronized for the Medical Device Directive.
Eudamed Led Changes Concerning the Post-Market Surveillance?
PMS requirements in addition to the episodic update of the clinical evaluation previously occurred before the effect of the MDR. But the MDR has meaningfully amplified the post-market requirements for producers and their responsibility to proactively gather data and state the examination of these post-market activities and data in report. To learn more about Eudamed, please read our expert blog on Eudamed.
Better transparency on post-market surveillance will be presented with Eudamed’s module on post-market surveillance and the organization’s responsibility will also include to feed this information in the database.
TS Q & E can offer relevant consultancy on the changes in the EU Medical Device Regulation, and how it will affect your post-market surveillance (PMS) program. Please let us know through our contact us or ask for quotation form.
