Case Study: Regulatory Intelligence Consulting Support for an EU Medical Device Manufacturer

Background – Client Needs:

An EU medical device manufacturer was looking to expand its market beyond Europe for a new medical device (Class IIb). The manufacturer was looking for Regulatory Intelligence for 48+ countries to market this new product leveraging their CE mark approval in the EU.

Celegence Solution & Approach:

Celegence was awarded a contract to provide Regulatory Intelligence services detailing information required for obtaining registration certificate in 48 countries. The initial research was done by the offshore Celegence team by using secondary research methods.

The information was gathered using public regulatory sources for each market including the following:

  • 1
    Regulatory agency websites, Regulatory Laws, Legislations or Policies, Guidance documents
  • 2
    Concept Papers
  • 3
    Drug Authorities Presentations
  • 4
    For countries or regions where the data was not accessible from initial research, the following approach was taken:

    • – Opinion and advice from Celegence’s internal operations team including publishing, submission, and clinical professionals
    • – Input from local Subject Matter Experts with experience registering devices in the concerned countries
    • – Email correspondence, and telephone enquiries with the concerned Health authorities and local agent
  • 5
    The output of the research and analysis was a comprehensive Regulatory Intelligence report with the required information for registration, including local classification, clinical trial requirements, import/export requirements, and local representative requirements. The report also included detailed steps for registering the device leveraging the CE mark and hence finding accelerated registration pathways.

Project Achievements

Celegence delivered the following value and business impact to the client:

  • Comprehensive and accurate registration requirements including steps, fees, and average timeline in order to inform regulatory strategy and minimize potential delays

  • Reduction of operational cost
  • Ongoing compliance improvement with access to Celegence’s regulatory expert network

  • Ability to digest only the useful and necessary information rather than a ‘data dump’ through simple and comprehensive RI report format

  • Consistent information across countries with an established report format for future expansion

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