Post-market surveillance (PMS) is defined as "a systematic process to derive necessary corrective and preventive actions (CAPA) from information on medical devices already placed on the market".
ISO 13485:2016 and ISO 14971:2012 require post-market surveillance. Moreover, the FDA published a revised guidance document in May 2016.
Update: MDR's requirements have been amended. Distinction between post-market surveillance and post-market clinical follow-up further specified.
Both the Medical Device Regulation (MDR) and the FDA define the term "post-market surveillance":
„all activities carried out by the manufacturers in cooperation with other economic operators to institute and keep up to date a systematic procedure to proactively collect and review experience gained from their devices placed on the market, made available or put into service for the purpose of identifying any need to immediately apply any necessary corrective or preventive actions“
The FDA's definition is comparable:
„The active, systematic, scientifically valid collection, analysis, and interpretation of data or other information about a marketed device.“
The FDA's definition may be conveniently short. However, the MDR's more long-winded explanation seems to be more helpful as it not only describes actions but also objectives of post-market activities.
Before bringing medical devices to market, manufacturers must minimize their risks and ensure patients' safety. This is monitored by authorities and notified bodies during authorization and conformity assessment procedure.
However, some risks manifest over time, when medical devices are used daily by practitioners.
Post-market surveillance aims at
Only due to a constant systematic market surveillance (post-market surveillance) can manufacturers guarantee that medical devices provide the promised benefit to patients as well as the lack of any unrestrained risks.
Please read below which data you can considered for market surveillance.
Closely connected to post-market surveillance are the terms "post-market clinical follow-up" (PMCF) and vigilance.
As already explained, post-market surveillance aims to continuously verify the benefits of medical devices and to identify previously unknown risks by observing and analyzing daily practical usage. If "regular market surveillance" does not provide sufficient data, post-market clinical follow-up studies regarding the manufacturer may become necessary.
If the PMS reveals information requiring changes to be made to the clinical evaluation, an update must be made. PMCF studies shall collect clinical data with the immediate aim to update and enhance clinical evaluations.
„A continuous process to update the clinical evaluation referred to in Article 49 and Part A of this Annex [XIII]“
Hence, post-market clinical follow-up (PMCF) is about systematically collecting clinical data to answer important questions regarding the safety or performance of medical devices which have been left unsolved.
Post-market surveillance involves collecting all kinds of meaningful practical information, for example also in form of service reports, hotline calls, customer complaints etc.
PMCF aims at updating clinical evaluation. The objective of post-market surveillance is to decide on necessary measures guaranteeing the safety of patients and practitioners. The decision takes the results of clinical evaluation into consideration. Therefore, PMCF is a subset of post-market surveillance.
The MDR regards post-market clinical follow-up as part of post-market surveillance. The MDR says, for example, that
The manufacturer shall undertake to institute and keep up to date a post-market surveillance plan, including a post-market clinical follow-up
However, the FDA does not differentiate between the two aspects as precisely as the MDR: The FDA requires the post-market surveillance plan to include data determined when conducting studies, such as the participant number, the study objective and declarations of consent.
A vigilance system refers to a market surveillance and reporting system. During vigilance, manufacturers must not only regulate how they surveil the market, but also how the report incidents to the responsible authority. Laws and regulations such as the MPSV leave manufacturers little scope for specifying the reporting system.
The activities within the scope of post-market surveillance, market surveillance, reporting, post-market clinical follow-up and vigilance are partly overlapping. Thus, the terms are often used as synonyms - although they aren't.
Regulatory requirements usually refer to several aspects.
The Medical Device Directive (MDD) explicitly requires (Appendix IX, clinical evaluation): manufacturers must update the clinical evaluation with data coming from post-market surveillance. They must justify if this process does not involve post-market follow-up.
The new Medical Device Regulation, which will replace the MDD from mid-2017 on, offers a way more detailed and specific description of the requirements put on post-market surveillance. As many as four articles and an appendix are dedicated to this topic.
Important requirements of the MDR regarding post-market surveillance are:
Appendix III lays down which sources must be analyzed and how they must be assessed.
ISO 13485:2016 obliges manufacturers to guarantee the effectiveness of QM systems a medical devices' safety amongst other through systematic market surveillance (post-market surveillance).
The norm on risk management too lays down requirements about the "subsequent phase". However, the norm's focus is not reporting. Rather, the norm is about using information coming from production or following stages (e.g. products' usage) to assess
Manufacturers acting under ISO 14971 must not only search for problems in the subsequent phase. All information aiding to verify or falsify the own assumptions' correctness is significant.
Please read below which data you can consider for market surveillance.
The risk management report must confirm that the planned activities are appropriate.
In 21 CFR part 822, the FDA provides precise regulations on:
On May 16, 2016, the FDA published a Guidance Document specifically on 21 CFR part 822 that was intended to give manufacturers additional guidance. A new draft of this Guidance Document was published in 2021.
Further information on the FDA requirements can be found in this article on 21 CFR part 822 and in the aforementioned Guidance Document.
The International Medical Device Regulators Forum (IMDRF) has adopted documents from the defunct Global Harmonization Task Force (GHTF) which incorporates guidelines mainly regarding reporting.
Although the MPG and MPSV demand a market surveillance, they impose specific requirements only on reporting and recalls.
The FDA lays down provision precisely governing
On May 2016, the FDA has issued a Guidance Document particularly on 21 CFR part 822 which offers manufacturers further assistance.
Please find further information on the FDA's requirements in this article on 21 CFR part 822 and the mentioned Guidance Document.
The European legislation on reporting (especially MEDDEV 2.12-1 and MPSV) is so extensive, specific and detailed. Therefore, manufacturers have little leeway when formulating respective process instructions.
However, European provisions on the actual market surveillance have not had as much impact on decision making so far - in contrast to the FDA's requirements. Now this will change due to the MDR with its much more comprehensive, precise and in-depth description of post-market surveillance. The following detailed tips assist you with implementation.
As a manufacturer of medical devices, you should structure your post-market surveillance, e.g. through respective standard operation procedure SOP, subject to the following aspects: