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In Vitro Diagnostic (IVD) Registration


In Vitro Diagnostics (IVD) Registration - Overview

The In Vitro Diagnostics (IVDs) sector is a rapidly expanding global market with a profound impact on healthcare. It employs laboratory equipment to detect diseases and infections, offering vital diagnostic information to both doctors and patients. In 2022, its global value stood at $117.8 billion, and it is estimated to reach $138.4 billion by 2027. This growth is propelled by factors like the surge in chronic diseases, heightened demand for diagnostic tests, an aging population, and advancements in technology.

Global Regulatory Scenario for IVD Registration

The worldwide Regulatory landscape for IVD registration is intricate and differs between the nations. IVDs are usually categorized by risk, with higher-risk IVDs subject to stringent regulations. Manufacturers of IVDs should meticulously examine the specific Regulatory demands of each target market. Furthermore, IVD manufacturers facing the complexities of global regulations should consider the following:

  • IVD Regulatory processes are intricate and time-intensive, emphasizing the importance of early planning.
  • IVD regulations vary by country. Manufacturers must diligently assess each market’s prerequisites for product introduction.
  • Engaging qualified Regulatory consultants aids in grasping market-specific requirements and preparing essential documentation.
  • The dynamic IVD Regulatory environment necessitates the ongoing awareness of changes to guarantee product compliance.

Registering IVDs in the international markets necessitates a tailored approach, involving close collaboration with the relevant Health Agencies for approval. The typical process for IVD registration involves the following steps:

  • Assessing whether a specific device meets the criteria for classification as an IVD.
  • Categorizing devices based on the associated risks.
  • Identifying the relevant standards and data prerequisites specified by the respective Health Agency.
  • Generating the necessary data as mandated by the Agency.
  • Compiling a technical file in accordance with the specific requirements of each country.
  • Submitting the application and addressing any queries or concerns until approval is obtained.
  • Managing the device's lifecycle post-approval.

Our Competencies

  • Initial risk analysis
  • Market research - Product-specific market insights
  • Staff augmentation
  • Draft Regulatory strategy
  • Potential markets and routes
  • Design file and risk analysis
  • Quality Management System (QMS) ISO 13485
  • Medical Device Single Audit Program (MDSAP)
  • QMS ISO 13485 pre-assessment
  • Regulatory strategy
  • Freyr IMPACT (Regulatory Intelligence Platform)
  • Design verification and validation
  • Risk management
  • Draft technical documentation
  • Regulatory strategy
  • Regulatory requirements
  • Freyr rDMS tool (Data/Documentation Management System)
  • Process and clinical validation
  • Final labeling and artwork
  • In-country representation
  • Regulatory submission
  • The European Union (EU) Conformité Européenne" (CE) marking and UK Conformity Assessment (UKCA) marking
  • Global market access certification
  • Notified Body (NB)/Approved Body audit support
  • In-country representation
  • Regulatory approvals
  • Post-market Surveillance (PMS)
  • Post-market Clinical Follow-up (PMCF)
  • Annual maintenance of technical file (Clinical Evaluation Report (CER)/Risk Management)
  • Regulatory renewals
  • New market launches
  • Competent Authority/Notified/Approved Body communication
  • Automated Pharmacovigilance (PV) solutions

Why Freyr?

Resource Centre

  • Blogs

    Understanding the Classification System for In Vitro Diagnostic Devices under the EU IVDR 2017/746

    Read More

  • Blogs

    5 Best Practices for Preparing Class C IVDs for Regulatory Approval Under EU IVDR 2017/746

    Read More

  • Blogs

    EU IVDR 2017/746 & Important Elements to Consider in Class B Regulatory Lifecycle

    Read More

Freyr Expertise and Advantages

Freyr Expertise

  • Comprehensive Regulatory strategy for IVDs.
  • Regulatory support for product development documents such as Design History Files (DHFs).
  • QMS compliance strategy. 
  • Regulatory compliance, gap analysis, and remediation of technical documents and quality systems.
  • Regulatory labeling and technical writing services.
  • Regulatory and market intelligence services.
  • Document and labeling translation services.
  • Health Agency liaising and service.
  • Regulatory artwork services.
  • Pharmacovigilance and PMS services.
  • Publishing services.
  • Medical writing services.

Freyr Advantages

  • Successful submissions for various classes of IVDs.
  • Dedicated and expert personnel to provide medical device and IVD Regulatory support.
  • On-time submission of deliverables.
  • Local affiliate access to meet the challenges of the Authority and language-specific requirements.
  • In-country or legal representative support with a cost-effective model.
  • Regulatory resource management/Staff augmentation services.

Contact us today Book a meeting to learn more about how we can help you navigate the Regulatory landscape and confidently bring your innovative IVDs to the market.