White Papers

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The Medical Device and In Vitro Medical Device Regulations represent the most significant change to the European legislation for medical devices for nearly 20 years. Understanding the requirements is key to your ability to develop an implementation plan to ensure continuing regulatory compliance and provide the EU market with safe medical devices.

A new white paper, “Planning for Implementation of the European Union Medical Devices Regulations: Are You Prepared?” focuses on the practical aspects of implementation. It discusses decisions that need to be made and includes questions to ask about your organization’s preparedness to comply with the new requirements.

Download this new white paper to learn how to address:

  • Activities and requirements for manufacturers, authorized representatives, importers, and distributors
  • Existing products and their technical documentation, including clinical evidence
  • Products in the development pipeline
  • Responsibilities of the person handling regulatory compliance, ISO 13485:2016 certification, and lifecycle management
  • Content and maintenance of technical documentation
  • Unique device identification, implant cards, and labelling changes
  • PMS plans, periodic safety update reports (PSURs) or post-market surveillance reports, and post-market clinical follow-up (PMCF)

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