Medical Device Labeling Requirements | VISTAAR

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Medical Device Labeling Requirements
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• Agenda

• Medical Device Labeling Requirements
• Summary of labeling requirements for some
  important Countries
• UDI requirements / Recent labeling updates
• Understanding the US FDA UDI and EU MDR
  Regulations
• Get your free copy of Whitepaper

www.vistaar.ai
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Medical Device Labeling Requirements

• The Medical device industry is well regulated by
  the FDA in the US, and many regional bodies
  internationally, including the EU MDD (Medical
  Device Directive) and the ASEAN MDD. These
  agencies detail requirements for the life cycle
  of medical devices from design, trials,
  documentation, labeling, packaging, delivery, and
  adverse event reporting all in the name of make
  the most of device safety and providing the
  utmost opportunity for positive patient outcomes.
  Managing the life cycle poses many challenges,
  most notably the challenge of meeting diverse
  requirements set by regional and local markets,
  and the constantly evolving nature of these
  requirements.

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Medical Device Labeling Requirements

• Medical device labeling is any information
  assists patients or their lay caregivers in
  understanding the device its operation, care,
  and maintenance the way it interacts with the
  body to accomplish its purpose its place and
  purpose in the patient care regimen and any
  safety or disposal issues.
• Medical device labeling is essential to assure
  safe and effective use of many, but not all,
  devices. It informs patients or their lay
  caregivers about proper use, risks, and benefits
  of the device in a language they can understand.
  Adequate directions for operating the devices are
  needed to make devices safe and effective. For
  example, as more patients use complex medical
  devices at home, medical device patient labeling
  becomes necessary to better communicate to the
  layperson how to operate the device.

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Topics covered in this Whitepaper include 

• Summary of labeling requirements for some
  important Countries
• UDI requirements / Recent labeling updates
• Understanding the US FDA UDI and EU MDR
  Regulations

www.vistaar.ai
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DOWNLOAD Medical Device Labeling Requirements
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