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K E Y R E Q U I R E M E N T S F O R
MEDICAL DEVICE POST MARKET SURVEILLANCE www.vista
ar.ai
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Presentation Outline
TOPICS Medical Device PMS Building an
Effective PMS Reactive (Incident-driven)
PMS Proactive (Review-driven) PMS The FDA
approach The EU approach
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Medical Device PMS

• The post-market surveillance(PMS) systems that
  monitor medical device safety after launch reduce
  both costs and demands on resources and
  increase product safety and performance. 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.

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Building an effective PMS
As a medical device or IVD manufacturer, it is
essential to ensure up-to-date procedures for
PMS to guarantee regulatory compliance and avoid
product recall. Building a PMS process, the
first thing to do manage product safety and
quality. This may include QA/RA, manufacturing,
design, field sales, and technical
support. There are two types of PMS reactive
and proactive. Reactive is the most common
approach used when setting up a PMS system, but
that doesnt mean a proactive approach isnt
important. A good PMS system can become great by
adding proactive measures to ensure only quality
products are in the field.
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Reactive (Incident-driven) PMS
Part of this process will involve the maintenance
of risk management files and a clear definition
of the prompt events that require further
investigation of complaints. The examples of
reactive PMS are
Information about serious incidents, including
field safety corrective actions Records
referring to nonserious incidents and data on any
undesirable side effects Information and
actions from trend reporting Information
(including feedback and complaint) provided by
users, distributors, and importers Proactive
(Review-driven) PMS This can include many
nontraditional sources, such as social media
(e.g., Facebook and Twitter), online product
reviews, online discussion forums, or blogs. As
part of PMS activities, have a plan or method for
evaluating this information. The examples of
proactive PMS are Relevant specialist or
technical literature, databases, and/or (patient)
registers Publicly available information about si
milar medical devices, such as FDAs Total
Product Life Cycle database Information from
other industries using the same technology as
your device (e.g., network connectivity)
Innovations from your competitors and
introduction of alternatives to your device, as
these lessen the clinical benefit of your device.
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The FDA approach
The EU approach

• Under section 522 of the Federal Food, Drug and
  Cosmetic Act in the Safe Medical Devices Act of
  1990 (SMDA), the FDA is authorized to require
  manufacturers to conduct PMS for certain class
  II and class III medical devices. These are
• Devices where failure would have serious adverse
  health consequences
• Devices that are implanted within the body for
  more than one year
• Devices intended to be life-sustaining or
  life-supporting being used outside a facility
• Devices expected to have significant use in
  pediatric populations
• Examples infusion pumps (class II) implantable
  pacemakers (class III) and HIV diagnostic tests
  (class III). The FDA can require a surveillance
  period of up to 36 months or longer, and
  manufacturers are required to comply with an
  order for PMS within 15 months of receipt.

• Post-market clinical follow up (PMCF) studies,
  detailed in the MEDDEV 2 .12/2 Rev 2 in January
  2012, are required for some devices that carry
  potential residual risks or need more clarity on
  long-term clinical performance, for example
• Innovative products
• Products that have undergone significant changes
• High risks relating to the product, its
  anatomical location of use, or the patient
  population
• Severity of disease
• Unanswered questions concerning safety or
  performance
• Issues with trial results, long-term safety,
  performance, adverse events, surveillance data
• Emerging safety or performance data

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