...
+91-7490017774 (For Enquiry Only) +91-7490017774 (For Enquiry Only) +91 9429952147 (For Career Only)
enquiry@mavenprofserv.com
Maven
Template
CE-for-In-Vitro-Diagnostic-Device-IVD

In Vitro Diagnostics Devices (IVDs) CE Marking or Certification Consultancy

  2. Services
  3. CE Certification Consultancy
  4. CE Consultancy for In Vitro Diagnostic Device (IVD)

We are a leading in vitro diagnostic device(IVD) regulatory consultants specializing in regulatory solutions for CE Marking for In Vitro Diagnostics Devices (IVDs).

When it comes to In vitro Diagnostic Devices (IVDs), our team offers consultation for techincal file preparation as per Regulation (EU) 2017/746, GAP analysis, compliance with Common Specifications (CS) for certain class D in vitro diagnostic medical devices (ivd) in accordance with Regulation (EU) 2017/746, performance evaluations, scientific validity writing, etc.

With years of experience and a large number of in-house In Vitro Diagnostic Devices (IVD) experts, we offer solutions that ensure smooth and effective CE marking process for In Vitro Diagnostic Devices (IVDs) and global compliance. So if you are looking to work with experienced CE mark In Vitro Diagnostic Devices (IVD) consultants, we’re here to help you every step of the regulatory pathway.

Regulation (EU) 2017/746 for In Vitro Diagnostic Medical Devices (IVDR)

The Regulation (EU) 2017/746, or IVDR (In Vitro Diagnostic Medical Devices Regulation) has a set of rules designed to make sure in vitro diagnostic medical devices that are placed in the EU market are safe, accurate, and trustworthy. This regulation focuses on requiring strong clinical evidence in the form of scientific validity, analytical performance studies and clinical performance studies, better tracking of devices, and more monitoring after the product is sold by having a Post-Market Surveillance Plan and Post-Market Performance Follow-up plan in place. Following the Regulation (EU) 2017/746 or IVDR (In Vitro Diagnostic Medical Devices Regulation), is essential for manufacturers to ensure their products meet General Safety and Performance Requirements (GSPR) by adhering to safety standards and regulatory requirements.

IVD Device Classification

IVDR Article 47 & Annex VIII introduce 4 classes based on risk levels possessed by the IVD device for CE marking, namely Class A, B, C, and D. Annex VIII provides 7 classification rules that apply based on intended use, target population, and technology. The classification of the In Vitro Diagnostic Devices (IVD) device is crucial as it determines the conformity assessment pathway, impacts whether a notified body is required, and also affects clinical evidence, performance evaluation, and PMS requirements. The higher the risk, the more testing and checks are needed before In Vitro Diagnostic Devices (IVD) CE marking.

If you need help in classifying your In Vitro Diagnostic Devices (IVD) for CE certification, a medical device regulatory consultancy can guide you through the process, so that you can determine the conformity assessment route.

IVDR Transition Timeline

The IVDR transition timeline highlights important dates for meeting the requirements of the In Vitro Diagnostic Regulation 2017/746 (IVDR).. Depending on the device classification, there are extended grace periods to help manufacturers stay on track with their obligations. This timeline is key for medical device manufacturers to achieve IVD CE marking and ensure their In Vitro Diagnostic Devices (IVD) meet the necessary standards for market access.

The EU In Vitro Diagnostic Medical Devices Regulation (IVDR – Regulation (EU) 2017/746) came into force on May 26, 2017, with a transition period replacing the IVDD (Directive 98/79/EC). However, due to the significant challenges faced by manufacturers and Notified Bodies, the EU Commission implemented a staggered transition timeline for legacy In Vitro Diagnostic Devices (IVD) to ensure smoother compliance.

Updated IVDR Transition Deadlines for Legacy Devices

To support a smoother shift from the In Vitro Diagnostic Medical Devices Directive (IVDD) to the new In Vitro Diagnostic Regulation (IVDR – Regulation (EU) 2017/746), the European Commission introduced revised transition deadlines for legacy IVD devices. These updates aim to give manufacturers additional time to meet the stricter requirements under IVDR, based on the risk classification of the devices.

As per the amendments to IVDR, the new transition timelines are as follows:

  • Class D Devices: Deadline extended to 26 May 2025
  • Class C Devices: Deadline extended to 26 May 2026
  • Class B Devices and Class A (sterile) Devices: Deadline extended to 26 May 2027

These extensions only apply to legacy devices—those that were certified or self-declared under the IVDD before 26 May 2022—and provided certain conditions are met, including:

  • The devices must continue to comply with IVDD requirements.
  • No significant changes to design or intended purpose.
  • The manufacturer must have applied for IVDR conformity assessment and signed a contract with a Notified Body by the relevant deadlines.

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.

Complete CE Marking Solutions for IVD Device Compliance with IVDR 2017/746

Maven is a CE consultancy for IVD devices, covering various types of products like general High to low risk In Vitro Diagnostic Devices (IVDs), self-testing IVDs, and other general In Vitro Diagnostic Device (IVD) consumables. Our In vitro diagnostic medical device regulatory consultants team supports you in preparing essential technical documentation, including GSPR, LOA, Declaration of Conformity, PerformanceEvaluation, Scientific Validity, Risk Management, Post-Market Surveillance, Software Validation, and also helps comply with Common Specifications (CS) compliance with our wide network of associate Clinical Research Organisations (CROs), testing laboratories.. We also provide guidance during conformity assessments and audits, ensuring a smooth and simplified process, so you can focus on delivering safe and effective medical devices to the market.

The In Vitro Diagnostic Device Regulation (IVDR) imposes stricter regulatory requirements. Our in vitro diagnostic medical device regulatory consultancts helps you avoid costly delays and ensures that your devices remain on the EU market with IVDR 2017/746.

Clinical-Evaluation

CE Marking Consultants

We have a team 100+ 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.

Frequently Asked Questions

CE marking for In Vitro Diagnostic (IVD) devices is a certification mark that indicates the device complies with the European Union’s regulatory requirements, specifically the In Vitro Diagnostic Medical Device Regulation (IVDR). It signifies that the IVD device meets essential safety, performance, and quality standards, allowing it to be legally marketed and sold within the European Economic Area (EEA). The CE mark assures users and regulators that the device is safe, reliable, and effective for its intended diagnostic use.

To achieve IVDR certification, IVD devices must be correctly classified (A–D) and supported by complete technical documentation, including design, safety, and manufacturing details. Manufacturers must provide robust performance evaluation, implement an IVDR-compliant QMS, and establish post-market surveillance. Additional requirements include UDI labelling, EUDAMED registration, and appointing an EU Authorized Representative (for non-EU companies). These steps ensure regulatory compliance, device safety, and market access under the EU IVDR framework.

The IVDR replaces the older IVDD, introducing stricter, enforceable regulations across the EU. Key changes include a risk-based classification system (Classes A–D), enhanced clinical evidence requirements, and greater involvement of notified bodies. IVDR also mandates robust post-market surveillance, UDI labeling, and centralized transparency via EUDAMED. Unlike the guideline-based IVDD, IVDR ensures higher safety, traceability, and regulatory oversight for IVDs in the EU market.

Under the IVDR (In Vitro Diagnostic Medical Device Regulation), involvement of a Notified Body is required for IVD devices classified as Classes B, C, and D due to their higher potential risk to patients and public health. Class A devices, except those intended for self-testing or those available in sterile form, generally do not require Notified Body assessment and can be self-certified by the manufacturer. The Notified Body’s role includes reviewing technical documentation, conducting conformity assessments, and verifying compliance with the regulation to ensure safety and performance before the device can be CE marked and marketed in the European Union.

Maven offers comprehensive regulatory consulting services to support manufacturers throughout the entire IVD CE marking and IVDR compliance process. Our expert team provides tailored guidance on device classification, gap analysis, technical file preparation, performance evaluation, and conformity assessments. We assist with documentation reviews, audits, and post-market surveillance strategies to ensure your IVD devices meet the stringent requirements of the EU In Vitro Diagnostic Medical Device Regulation (IVDR). Additionally, we support EUDAMED registration, UDI labeling, and quality management system implementation, helping you achieve seamless certification and market access in Europe with confidence and regulatory assurance.

Click Here to play Video

Connect With Us