• 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
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    • Our Team
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    • Mission
    • Links
    • Let us help you with your documents

+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

Medical Devices Regulation (MDR)

Technical Documentation

The European regulation on medical devices (Regulation EU 2017/745, ‘MDR’) applies since 26 May 2021, following a four-year transition period. Manufacturers must comply with the Regulation when placing new medical devices on the market. The MDR repeals Directive 93/42/EEC on medical devices and the Directive 90/385/EEC on active implantable medical devices.

Manufacturers of devices other than custom-made devices shall draw up and keep up to date technical documentation for those devices. The technical documentation shall be such as to allow the conformity of the device with the requirements of the Regulation to be assessed. The technical documentation shall include the elements set out in Annexes II and III of the MDR.

Preparing the technical documentation including writing the underlying documents can be quite overwhelming.  BioTop Medical can help you with this task.

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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