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CE Marking Consultancy for In Vitro Diagnostic Devices (IVDs)

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

Maven Profcon Services LLP provides professional IVD CE Marking consultancy for in vitro diagnostic devices manufacturers to comply with the EU IVDR Regulation (EU) 2017/746. We support at every stage of the IVD CE Marking process, device classification, technical documentation preparation, performance evaluation, notified body support, and post market compliance, and many more.

IVD device classification as per IVDR

Under IVDR Annex VIII, IVD devices are classified into Class A, B, C, and D based on risk, type of clinical condition, intended use, and target population. Correct classification is critical because it determines the conformity assessment route, the level of Notified Body involvement, the depth of performance evaluation, and post-market surveillance and PMPF requirements.

Our experienced IVDR consultants help you accurately classify your IVD medical device for CE marking, ensuring alignment with regulatory expectations and avoiding delays or non-compliance.

CE Marking Support for IVDs – How We Help

We help manufacturers of in vitro diagnostic devices get CE marked and meet EU IVDR 2017/746 requirements.

  • We check what EU IVDR requirements apply to your IVD device.
  • Guide you on the right selection of the conformity assessment route.
  • We prepare and review technical documents.
  • Help in the selection of Notified Bodies.
  • Support you during audits and the closure of non-conformities.

We make the CE marking process easier so you can focus on creating safe and effective diagnostic devices.

Technical Documentation (EU IVDR)

icon Analytical Performance Protocol & Report

Our team helps you prepare Analytical Performance Protocol as per the requirements of IVDR and compile the data for Analytical Performance Report. These documents present key data on accuracy, precision, sensitivity, and specificity, giving a clear and reliable view of the device’s analytical performance. They support regulatory review by presenting results in a structured, simple, and transparent manner.

icon Scientific Validity

Our team helps you prepare Scientific Validity Plans and Reports that clearly demonstrate the link between your IVD device, the target analyte, and the clinical condition it is intended to detect. Using scientific literature, clinical guidelines, and accepted evidence, we ensure the data proves the clinical relevance of the test results. These documents are prepared in line with IVDR requirements and support both regulatory submission and ongoing performance evaluation of your device.

icon Technical File

Our IVDR consultants prepare technical file for in vitro diagnostic (IVD) devices as per the requirement of IVDR 2017/746. Our team will identify the requirements of technical documentation as per the IVDR and product application.

Professional-Consulting-for-medical-devices

icon Clinical Performance Protocol & Report

Our team helps you prepare Clinical Performance Protocol in line with IVDR requirements and compile data for Clinical Performance Report. These documents demonstrate how well your IVD performs in real clinical settings and confirm that the test results are clinically relevant. They support regulatory review by presenting clinical evidence in a clear, structured, and transparent way.

icon Performance Evaluation

Our team will help in preparing the performance evaluation plan and report which helps manufacturers prove that their in vitro diagnostic (IVD) devices are safe, accurate, and work as intended. It brings together scientific validity, analytical, and clinical performance to meet general safety and performance requirements under IVDR 2017/746. A clear and well-documented performance evaluation make the easy way for the CE marking for your IVD device.

icon Post Market Surveillance

Our IVDR consultants prepares PMS documentation in accordance with the requirements of IVDR. PMS documentation for IVDs includes the PMS plan and report, PSUR, and PMPF plan and report.

Complete IVD CE Marking Solutions for your IVD Device under IVDR 2017/746

Maven provides expert CE consultancy for in vitro diagnostic devices, supporting low to high risk IVDs, self-testing IVDs, and IVD consumables. We help manufacturers achieve IVD CE Marking by preparing complete IVDR-compliant technical documentation, including GSPR, performance evaluation, scientific validity, risk management, post-market surveillance, and software validation. Our consultants also guide you through conformity assessments and audits, helping you meet IVDR (EU) 2017/746 requirements and maintain smooth access to the EU market.

CE Marking Solutions for IVD Device

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 A(sterile), B, C, and D due to their higher potential risk to patients and public health. Class A devices, those available in non-sterile form, generally do not require Notified Body assessment and can be self-certified by the manufacturer.

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.