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    • Auditing
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    • In-Vitro Diagnostic Devices Regulations
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+31 (0)71 528 01 12

Contact us

Technical Documentation

  • Medical Devices Regulations
    • Risk management
    • Clinical evaluation
    • Biological Safety Asessment
    • Other
  • In-Vitro Diagnostic Devices Regulations
    • Risk management
    • Performance evaluation
    • Other

For direct contact call
+31 (0)71 528 01 12

Technical Documentation

In Vitro Diagnostic Medical Devices Regulation (IVDR)

The European regulation on in vitro diagnostic medical devices, Regulation EU 2017/746 ‘IVDR’, came into effect in May 2017. This regulation repealed Directive 98/79/EC ‘IVDD’ with a five-year transition period to achieve compliance and has been in force since May 2022. Full compliance with the regulation is obligatory for manufacturers who wish to place their products in the European market.

Manufacturers are required to create a technical documentation composed of highly detailed product information. This documentation must be prepared in compliance with the regulation and applicable standards and other relevant guidance documents. Additionally, these files must be maintained and updated on a regular basis.

Due to the complexity of the task and the extensive amount of documents that needs to be prepared, compiling the technical documentation can be overwhelming. BioTop Medical can take over this responsibility for you.

Get in touch

BioTop Medical

  • Poortgebouw Noord
  • Rijnsburgerweg 10
  • 2333 AA Leiden, The Netherlands
  • T:+31 (0)71 528 01 12
  • F:+31 (0)71 528 10 15
  • info@biotopmedical.nl

Quality Managment System

  • QMS Implementation
  • Auditing

Technical Documentation

  • Medical Devices Regulations
    • Risk management
    • Clinical evaluation
    • Biological Safety Asessment
    • Other
  • In-Vitro Diagnostic Devices Regulations
    • Risk management
    • Performance evaluation
    • Other

Let us help with your documents

  • We conduct literature searches
  • We collect and assess clinical datasets and write clinical evaluation reports (CERs)
  • We lead and oversee the risk management process
  • We write the biological safety assessment report
  • We prepare your technical documentation
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Contact us
  • Quality Management System
    • QMS Implementation
    • Auditing
  • Technical documentation
    • Medical Devices Regulations
    • In-Vitro Diagnostic Devices Regulations
  • Market access
    • Start-ups
    • Medium sized companies
    • Established multinationals
    • Areas of the world
  • About BioTop Medical
    • History
    • Our Team
    • Jobs
    • Mission
    • Links
    • Let us help you with your documents

BioTop Medical

  • Poortgebouw Noord
  • Rijnsburgerweg 10
  • 2333 AA Leiden, The Netherlands
  • T:+31 (0)71 528 01 12
  • F:+31 (0)71 528 10 15
  • info@biotopmedical.nl

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