180:, to which doctors or the general public can voluntarily report adverse reactions to drugs and medical devices. The FDA also conducts active surveillance of certain regulated products. For example, the FDA may monitor safety and effectiveness of medical devices through either a Post-Approval Study or through a 522 Postmarket Surveillance Study. With respect to regulation, two terms are defined: Postmarketing requirements are studies and clinical trials that sponsors are required to conduct and postmarketing commitments are studies or clinical trials that a sponsor has agreed to conduct, but that are not required by a statue or regulation.
125:‘post-market surveillance’ means all activities carried out by 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 devices they place on the market, make available on the market or put into service for the purpose of identifying any need to immediately apply any necessary corrective or preventive actions;
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Further requirements on PMS are given in §83 of the MDR; §84 details PMS Plan requirements and references
Section 1.1 of Annex III of the MDR; §85 details the PMS report, while §86 describes the contents of the Periodic Safety Update Report (PSUR).
54:, which involve relatively small numbers of people who have been selected for this purpose – meaning that they normally do not have other medical conditions which may exist in the general population – postmarketing
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117:. A manufacturer of medical devices is required to report incidents (serious adverse events) to the national competent authority of the member state the company resides in. The Medical Device
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The MDCG Guideline 2023-3 "Questions and
Answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 on medical devices" provides further clarification on the topic.
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can further refine, or confirm or deny, the safety of a drug or device after it is used in the general population by large numbers of people who have a wide variety of medical conditions.
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is the regulatory body which approves drugs, and it has a division called "Marketed Health
Products Directorate" (MHPD) which coordinates Canadian postmarketing surveillance.
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Postmarketing surveillance uses a number of approaches to monitor drug and device safety, including spontaneous reporting databases, prescription event monitoring,
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Zippel, Claus; Bohnet-Joschko, Sabine (2017). "Post market surveillance in the german medical device sector - current state and future perspectives".
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Similar provisions on Post-Market
Surveillance are found in the European regulation on in vitro diagnostic medical devices (
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between health databases. These data are reviewed to highlight potential safety concerns in a process known as
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The guidance document "MEDDEV 2.12-1 rev 8" offers a comprehensive guidance on best practice for
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after it has been released on the market and is an important part of the science of
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121:(MDR) provides in §2 the following definition of post-market surveillance:
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218:"The Value of Patient-Centred Registries in Phase IV Drug Surveillance"
50:. Since drugs and medical devices are approved on the basis of
176:(FDA), which operates a system of passive surveillance called
418:"Postmarketing Requirements and Commitments: Introduction"
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McNeil JJ, Piccenna L, Ronaldson K, et al. (2010).
346:"Post-Market Surveillance and Vigilance: MDR vs IVDR"
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Medicines and
Healthcare products Regulatory Agency
38:, is the practice of monitoring the safety of a
267:"Post-marketing Pharmacosurveillance in Canada"
172:Postmarketing surveillance is overseen by the
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103:medical device post-market surveillance
304:Health Policy (Amsterdam, Netherlands)
403:"522 Postmarket Surveillance Studies"
269:. Health Canada. 2005. Archived from
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105:(materiovigilance). The concept of
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316:10.1016/j.healthpol.2017.06.005
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458:Regulation of medical devices
375:"Post-marketing Surveillance"
154:Commission on Human Medicines
109:is linked to the concepts of
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174:Food and Drug Administration
18:Post marketing surveillance
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156:(CHM) jointly operate the
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63:electronic health records
190:Medical device reporting
119:Regulation (EU) 2017/745
107:post market surveillance
36:post market surveillance
416:FDA (3 November 2018).
389:"Post-Approval Studies"
195:List of withdrawn drugs
81:National implementation
453:Pharmaceuticals policy
405:. U.S. FDA/CDRH. 2014.
391:. U.S. FDA/CDRH. 2014.
377:. U.S. FDA/CDER. 2004.
162:adverse drug reactions
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363:MDCG Guideline 2023-3
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115:market surveillance
40:pharmaceutical drug
234:10.1007/bf03256826
158:Yellow Card Scheme
67:patient registries
443:Clinical research
48:pharmacovigilance
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252:2011-06-17
201:References
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222:Pharm Med
111:vigilance
332:28697849
242:19091146
184:See also
178:MedWatch
164:(ADRs).
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148:The
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