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Dealing with post-market surveillance, or PMS, is a very important part of having medical devices on the EU market. It is also one of the focus areas of the notified bodies. This makes it essential for all manufacturers and others working within the medical device industry.
The following video explains PMS more thoroughly. It is taken from our Introduction to the Medical Device Regulation (EU) 2017/745 online course.
The requirement to perform PMS is found in Article 83 of the MDR. It is clear from the beginning that there needs to be a system for the PMS activities, meaning procedures describing the process, and also tools to conduct the work.
The PMS system needs to be proportionate to the risk class of the device: the higher the classification of the medical device, the more rigorous the system should be. It also needs to be an integrated part of the manufacturer’s QMS.
This part of the QMS shall include instructions on how to plan, document, maintain and update the PMS system.
This PMS system shall actively and systematically gather, record, and analyse relevant data on the quality, performance, and safety of a device throughout its entire lifetime. This data needs to be recorded and analysed to determine any necessary corrective or preventive actions that the manufacturer needs to implement, as well as monitor their effectiveness.
In the case of identified corrective and/or preventive actions, they need to be reported to the competent authorities concerned and, if applicable, to the notified body.
Actively and systematically collecting data means that one should be proactive and not reactive, meaning it is always better to prevent than correct – which saves both time and money. Preventive actions are always preferred over corrective actions, and preventive actions can only be taken if you have a proactive PMS system since reactive PMS systems would normally only result in corrective actions.
Searching for information can be done by screening relevant information relating to the medical device in question or similar devices in the market using databases like EUDAMED, the US Maude database, or clinical study databases like, for example, Pubmed.
One of the key considerations for the PMS plan is to include where and how to search for relevant information.
The PMS data shall also be used to review and potentially update the benefit-risk determination and improve the risk management system, to update the design and manufacturing information, as well as the instructions for use and labelling.
The PMS data shall also be used to update the clinical evaluation through the PMCF part of the PMS system, and also, where applicable, the summary of safety and clinical performance for the manufacturers of implants and class III devices.
The PMS data collected and analysed might trigger the need to implement field safety corrective actions. And in the case where the manufacturer needs to take such actions, they must also follow the requirements for proper handling of them.
The PMS data is considered to be able to potentially improve the usability of the devices which needs to be understood as being very tightly linked to risk management.
Finally, the PMS data is used is to detect trends and potentially report them to EUDAMED if needed. Requirements on trend reporting is also covered more in details in the vigilance part of the MDR (article 87).
Considering the above, it is clear that PMS is not only about managing customer complaints. Even if customer complaints are an important part of PMS input, there are obviously many other things to consider also.
Other things to consider are authorised representatives, importers and distributors who are also involved in the PMS activities, since they can be the ones forwarding PMS data to the manufacturer and potentially support the manufacturers in management of actions related to products on the market.
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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