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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

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+31 (0)71 528 01 12

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Clinical evaluation

The Clinical Evaluation Report (CER) is compulsory for the CE – marking of every medical device, regardless of the product classification. The clinical evaluation is the assessment and analysis of clinical data sets pertaining to a medical device to demonstrate:

  • the clinical performance and safety of the device;
  • that the device technology is state-of-the-art;
  • that the device benefits outweigh the device risks and finally
  • that the device (design) complies with the General Safety and Performance Requirements of the MDR.

Contrary to the MDD, the MDR states explicity the requirements for the clinical evaluation under Article 61 and Annex XIV of the regulations.

Clinical data can be obtained from one or more sources and it shall be assessed according to a defined and sound methodology, based on the EU guidance: MEDDEV 2.7/1 revision 4, from 2016.

The literature search is a mandatory source of clinical data. The results of the systematic search of the literature published about the device in question or equivalent devices as well as publications regarding alternative technologies are processed according to a predetermined method, also based on the guidance provided by MEDDEV 2.7/1. The method and the results of the assessment are respectively described and reported in the Clinical Evaluation Report (CER).

To achieve regulatory compliance, the clinical evaluation must be systematic, thorough and unbiased with the objective of demonstrating the validity of the clinical evidence on the safety and performance of the device. This task requires an expertise that is often not available at companies marketing medical devices. The research and scientific background of the team at BioTop Medical enabled us to develop the required competence for:

  • searching and processing clinical literature;
  • performing the clinical evaluation of medical devices based on literature and other clinical data sets (e.g. Clinical Trials, Post-Market Surveillance Reports);
  • writing the Literature Search Report and the Clinical Evaluation Report.
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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  • Please read our disclaimer
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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