Call Now

IVDR CE Marking Services

Cert3Global offers expert IVDR CE Marking Services to help manufacturers of in vitro diagnostic (IVD) devices achieve compliance with EU IVDR (2017/746). From regulatory assessment to technical documentation and certification, we support you through the complete CE marking process—ensuring your product meets all European regulatory requirements.

Our structured approach helps reduce delays, improve documentation accuracy, and support smooth market entry across the European Economic Area.

Book a Free 15-Minute Compliance Call
Get IVDR Support

Expert IVDR CE Marking Support for IVD Devices

The In Vitro Diagnostic Regulation (IVDR 2017/746) has introduced stricter requirements for IVD devices in the European Union. Manufacturers must now meet enhanced standards for performance evaluation, clinical evidence, risk classification, and post-market surveillance.

Cert3Global provides focused IVDR CE Marking Services to help manufacturers navigate these requirements efficiently. We support you in understanding regulatory expectations, preparing compliant documentation, and managing the certification process.

Our goal is to simplify IVDR compliance and help you move from product development to CE certification with clarity and confidence.

What is IVDR CE Marking?

IVDR CE marking is a conformity process that confirms an in vitro diagnostic device meets the requirements of EU Regulation 2017/746. It allows manufacturers to legally market their IVD products within the European Union.

To obtain IVDR CE marking, manufacturers must demonstrate compliance through technical documentation, performance evaluation, risk management, and quality system implementation. Depending on the classification of the device, involvement of a Notified Body may also be required.

Once compliance is achieved, the manufacturer issues a Declaration of Conformity and affixes the CE mark to the device.

Why is IVDR CE Marking Important?

IVDR CE marking is mandatory for all in vitro diagnostic devices entering the EU market. Without it, products cannot be legally sold or distributed.

The IVDR framework introduces more rigorous requirements compared to previous directives, making compliance essential not only for market access but also for maintaining product credibility and safety.

Key Benefits

  • Enables legal market access in the EU
  • Ensures compliance with IVDR 2017/746
  • Improves product reliability and regulatory acceptance
  • Reduces risks of non-compliance and delays
Working with professional IVDR CE Marking Services helps ensure the process is completed accurately and efficiently.
Contact Us !

IVDR CE Marking Services

Cert3Global provides specialized IVDR CE Marking Services covering the key regulatory requirements for IVD device compliance and certification.

Regulatory Assessment & Gap Analysis

We evaluate your device against IVDR requirements to identify gaps and define a clear compliance strategy.

IVD Classification & Conformity Assessment

We determine the correct classification (Class A, B, C, D) and guide you through the appropriate conformity assessment route.

Technical Documentation Support

We assist in preparing IVDR-compliant technical documentation, including performance evaluation, risk management, and scientific validity.

Performance Evaluation & Clinical Evidence

Support for performance evaluation reports, analytical performance, and clinical evidence as required under IVDR.

Notified Body Coordination

We assist in selecting and coordinating with Notified Bodies for devices requiring third-party assessment.

Quality Management System (QMS) Support

Guidance on implementing and maintaining ISO 13485-compliant systems aligned with IVDR.

Declaration of Conformity & CE Marking

We support preparation of the Declaration of Conformity and correct application of CE marking.

IVDR CE Marking Process

The IVDR CE marking process involves structured steps that must be followed to demonstrate compliance:
  • Classification of the IVD device based on risk
  • Identification of applicable IVDR requirements
  • Preparation of technical documentation
  • Performance evaluation and clinical evidence generation
  • Implementation of a quality management system
  • Notified Body assessment (for Class B, C, D devices)
  • Issuance of Declaration of Conformity
  • Affixing CE marking
Each step must be completed accurately to ensure successful certification and avoid delays.

Who Needs IVDR CE Marking?

IVDR CE marking is required for manufacturers of in vitro diagnostic devices who intend to sell their products in the European Union.
This includes:
  • EU-based manufacturers
  • Non-EU manufacturers entering the EU market
  • Companies transitioning from IVDD to IVDR
  • Businesses launching new IVD products
Non-EU manufacturers must appoint an EU Authorized Representative to comply with regulatory requirements.

Why Choose Cert3Global?

Cert3Global provides structured and reliable IVDR CE Marking Services tailored specifically for IVD manufacturers.
We offer:
  • End-to-end IVDR compliance support
  • Expertise in IVD classification and performance evaluation
  • Technical documentation assistance
  • Notified Body coordination
  • Practical regulatory guidance
Our focus is on helping you achieve compliance efficiently while minimizing delays and regulatory risks.

IVDR CE MARKING PROPOSAL REQUEST

1. IMPORTANT INFORMATION -

Step 1 of 6

You must fill in the details requested to receive a precise IVDR CE Marking service proposal. Based on the data entered below online, we determine the price and timeline. We are aware that this may be quite challenging for startup business owners and manufacturers, but we must have it to properly serve and support you! Do not forget to complete a separate form for each device you intend to CE mark .

2. MANUFACTURER INFORMATION -

Step 2 of 6

Postal Code

3. ADMINISTRATIVE INFORMATION -

Step 3 of 6

4. IVD DEVICE INFORMATION (1) -

Step 4 of 6

What is the purpose of this device?
Find GMDN Code from the below link. https://www.gmdnagency.org/account/login?ReturnUrl=/Terms/SearchFind GMDN Code from the below link. https://www.gmdnagency.org/account/login?ReturnUrl=/Terms/Search
Find EMDN Code from the below link. https://webgate.ec.europa.eu/dyna2/emdn/
Find IVDR Code from the below link. https://www.i3cglobal.com/wp-content/uploads/2024/02/IVDR-CODES.pdf

IVD DEVICE INFORMATION (2) -

Step 5 of 6

5. SUBMITTER INFORMATION -

Step 6 of 6

Start Your IVDR CE Marking Process!

IVDR compliance requires detailed documentation, regulatory expertise, and careful planning. Cert3Global supports you through every stage of the process, ensuring your IVD devices meet all requirements for CE marking and EU market access.
Book a Free 15-Minute Compliance Call

FAQs

What is IVDR CE marking?
MDR CE marking confirms that a medical device complies with EU MDR 2017/745 regulations.
Yes, IVDR compliance is required for all IVD devices sold in the EU.
Most devices (Class B, C, D) require Notified Body involvement.
It includes scientific validity, analytical performance, and clinical performance data.
Yes, but they must appoint an EU Authorized Representative.

Disclaimer

Cert3Global provides regulatory consulting and support services. Registration outcomes, timelines, and market access remain subject to applicable UK regulations and MHRA processes.