Technical standards and legislation for implants and implantable medical devices

D. M. Vasconcelos, J. Cortez, M. Lamghari

Research output: Chapter in Book/Report/Conference proceedingChapterpeer-review


Advances in medical devices have had a clear impact on the level and quality of healthcare provided worldwide, as well as on patients’ quality of life and life expectancy. A wide range of medical devices have been developed in past decades, creating a growing global market of €310 billion (2013). Medical devices involve several configurations and features, and their classification and regulatory pathways can be complex, varying from country to country. This highlights the growing need for a consensus regarding medical device regulation. This article provides a simple overview and a practical tool for researchers and manufacturers of implantable medical devices. The definition, classification, technical requirements, conformity assessment, and postmarket surveillance underlying medical devices approval, as well as the future of their regulation, are addressed herein.
Original languageEnglish
Title of host publicationMaterials science and materials engineering
ISBN (Print)9780128035818
Publication statusPublished - 2016
Externally publishedYes


  • CE marking
  • Essential requirements
  • Implants
  • Medical devices
  • Postmarket surveillance
  • Premarket approval
  • Premarket notification 510(k)
  • Regulatory pathways
  • Risk-based classification
  • Technical standards


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