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IVD CE Marking and IVDR Certification

  2. Services
  3. Europe
  4. CE for In Vitro Diagnostic Device

We deal with the aspects of professional Consulting for medical devices

We Are A Premium Regulatory Compliance Solutions Provider For IVD CE Marking and IVDR Certification

We are a leading provider of regulatory compliance solutions for IVD CE Marking and IVDR Certification. Our expert team specializes in consultations, audits, GAP analysis, conformity assessments, document reviews, and technical evaluations, ensuring seamless certification. Backed by industry professionals, we deliver tailored solutions for regulatory excellence and global compliance.

IVDR Regulation

The IVDR (In Vitro Diagnostic Medical Devices Regulation) sets stringent guidelines to ensure the safety, accuracy, and reliability of diagnostic devices in the European market. It emphasizes robust clinical evidence, improved traceability, and stronger post-market surveillance, making compliance critical for manufacturers to deliver high-quality products while meeting regulatory expectations.

IVD Device Classification in Europe

IVD device classification in Europe is governed by the In Vitro Diagnostic Medical Device Regulation (IVDR). It categorizes devices into four risk classes: A, B, C, and D, based on their intended purpose and potential risks. Proper classification is essential for compliance, ensuring device safety, and meeting regulatory requirements.

IVDR Transition Timeline

The IVDR transition timeline outlines key deadlines for compliance with the EU In Vitro Diagnostic Medical Device Regulation. It includes extended grace periods based on device classification and mandates manufacturers to meet stringent requirements for clinical evidence, labeling, and performance evaluations, ensuring patient safety and regulatory alignment across the European market.

icon Technical File

The technical file for in-vitro diagnostic (IVD) devices comprises all the essential documents an IVD manufacturer must submit to a Notified Body (NB) or Competent Authority (CA). These documents are crucial for the review and approval process required to obtain CE certification, ensuring that the device complies with applicable regulatory standards for safety, performance, and quality.

icon Performance Evaluation

Performance evaluation helps manufacturers establish robust scientific, clinical, and analytical evidence to demonstrate that their in vitro diagnostic (IVD) devices meet general safety and performance requirements. This critical process ensures compliance with regulatory standards, validating the device's effectiveness and reliability. By conducting thorough evaluations, manufacturers can provide documented proof of conformity, fostering trust and ensuring the safety and accuracy of their diagnostic solutions for users and patients.

icon Post Market Surveillance

Post-market surveillance (PMS) is a comprehensive system designed to continuously monitor and gather feedback on medical devices once they are available in the market. This ongoing process plays a crucial role in identifying potential issues, ensuring product performance, and maintaining high standards of quality and safety. By proactively addressing concerns and improving device functionality, PMS helps manufacturers uphold regulatory compliance and enhance overall patient care.

icon EU Representative

To market In-Vitro Diagnostic devices in Europe, non-European manufacturers must designate an authorized European representative. This representative acts as a liaison between the manufacturer and European regulatory authorities, ensuring compliance with the region's regulatory requirements. They assist with documentation, regulatory submissions, and post-market surveillance, facilitating smooth market entry and adherence to the In-Vitro Diagnostic Regulation (IVDR). Appointing a reliable representative is essential for seamless device distribution within the European Union.

Professional-Consulting-for-medical-devices

icon EUDAMED Registration

The European Database on In-vitro Diagnostic Devices (EUDAMED) is an IT system developed by the European Commission to implement Regulation (EU) 2017/745 on Medical Devices and Regulation (EU) 2017/746 on In-vitro Diagnostic Devices. EUDAMED aims to enhance transparency, facilitate regulatory procedures, and improve the monitoring of medical and in-vitro diagnostic devices across the EU, ensuring compliance with the latest regulatory standards.

icon UDI Labelling

The Unique Device Identification (UDI) is a standardized alphanumeric code designed for global recognition and identification of medical devices. It enables clear, consistent, and harmonized device identification across markets, ensuring that each medical device can be easily distinguished. This system improves traceability, enhances safety, and facilitates efficient regulatory processes, helping healthcare providers and patients make informed decisions while ensuring compliance with international regulations.

icon Performance Testing

Performance testing is essential for demonstrating that an IVD device meets its intended use. It serves as key evidence of compliance with international standards and regulations, ensuring the device operates effectively and safely. By conducting thorough performance tests, manufacturers can confirm that their IVDs meet regulatory requirements and deliver reliable results, supporting their certification process for global market access.

icon Quality Management System

It is a structured system of processes that covers all essential elements an organization must follow when designing, developing, and manufacturing an IVD medical device. This system ensures compliance with regulatory standards and guidelines throughout the entire lifecycle of the device, from initial design to production. By adhering to these processes, organizations can achieve quality, safety, and effectiveness in their IVD medical devices while meeting industry-specific requirements and ensuring regulatory approval.

One-Stop Solution for IVD CE Marking

Our In-vitro Diagnostic (IVD) Device CE Marking services cover a wide range of products, including General IVDs, Self-testing IVDs, and all other device classes. We assist manufacturers in navigating the complex regulatory requirements for obtaining CE Mark certification, enabling them to legally market and sell their products within the European Union. Our expert team ensures that every aspect of the certification process, from documentation to conformity assessment, is handled efficiently. With a focus on compliance and quality, we provide comprehensive support to ensure that your IVD devices meet EU standards for safety, effectiveness, and regulatory approval.

Clinical-Evaluation

CE Marking Consultants

We have a team 20+ talented, skilled & experienced technical consultants. Our CE marking consultants help the manufacturers to place their IVD medical devices on European Market.

Document Control

We take care extra care to maintain control over documentation and client confidentiality which creates value and helps us maintain client’s best interests.

Annual Maintenance

Our Regulatory consultancy provides customizable services to update and maintain your regulatory framework and QMS and complying with the needs of various regulations.

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