IVD CE Marking Services Under the EU IVDR
IVD CE marking is mandatory for every manufacturer that wants to sell in vitro diagnostic devices in the European Union. The process is governed by the IVDR Regulation (EU) 2017/746, which replaced the IVD Directive 98/79/EC. I3CGlobal supports manufacturers through the full IVDR conformity assessment from start to finish: technical documentation, performance evaluation reports (PER), ISO 13485 implementation, risk management, PMS and PMPF, and notified body coordination.
Need Support for IVD CE Marking and IVDR Compliance?
As an IVD CE marking service provider, I3CGlobal guides manufacturers through the complexities of the EU IVDR and supports faster access to the European market. We combine regulatory documentation with product technical consultation, so the evidence and the documents match.
Class A, B, C and D devices
Every risk class, from self-declared Class A to Class D blood screening assays.
Performance evaluation support
Scientific validity, analytical and clinical performance and the PER.
IVDR technical documentation
Annex II and III files prepared and kept audit-ready.
Global regulatory expertise
Support for manufacturers worldwide, with an EU authorised representative where needed.
How We Take Your IVD Through IVDR Conformity Assessment
For a phase-by-phase breakdown, see our IVDR CE marking process. In short, getting the CE mark under the IVDR involves several regulatory and technical steps that demonstrate the safety, performance and compliance of the device before it reaches the European market.
- Classify the deviceConfirm the intended purpose and apply the Annex VIII rules to find the class (A, B, C or D). See IVDR classification.
- Implement the QMSSet up or upgrade an EN ISO 13485 quality management system that meets IVDR Article 10(8).
- Prepare the performance evaluationPlan and document scientific validity, analytical performance and clinical performance in a PER.
- Build the technical documentationCompile the Annex II and III file, including risk management, GSPR checklist, stability, labelling and IFU.
- Appoint an EU representativeManufacturers outside the EU appoint an EU authorised representative.
- Notified body assessmentClass B, C, D and sterile Class A devices are assessed by a notified body; non-sterile Class A is self-declared.
- Declare, CE mark and registerSign the declaration of conformity, affix the CE mark, assign UDIs and register in EUDAMED.
- Maintain complianceRun post-market surveillance, PMPF and vigilance, and keep the technical documentation up to date.
For a phase-by-phase breakdown of what the consultant delivers and what the manufacturer provides, see our IVDR certification statement of work.
IVDR Requirements for IVD Manufacturers
Every IVDR application rests on the same building blocks. The depth of each grows with the risk class. The full requirements are set out in the official text of Regulation (EU) 2017/746 on EUR-Lex.
IVDs are classified by risk. Class A is low risk, such as specimen containers. Class B is moderate risk. Class C is higher risk and includes many infectious disease tests. Class D is the highest risk and includes blood screening tests such as HIV assays.
IVD manufacturers must control design, manufacturing and quality through a QMS. Following EN ISO 13485:2016 is the usual way to show IVDR compliance.
The technical documentation file (TDF) covers device description, intended use, design and manufacturing, risk management, performance evaluation, analytical performance, stability, labelling and IFU.
Shows that the device gives correct results, through scientific validity, analytical performance and clinical performance.
Class B, C and D (and sterile Class A) applicants submit the TDF to a notified body for review and certification.
Manufacturers outside the EU must appoint one. The representative communicates with EU authorities and checks the manufacturer meets its obligations.
The manufacturer signs the EU declaration of conformity in a controlled format, confirming compliance with the IVDR, and keeps it with the TDF.
Evidence of how each Annex I General Safety and Performance Requirement is met, with standards and test reports.
Unique device identification and registration of the manufacturer and devices in EUDAMED.
IVD CE Marking Route by Risk Class
| Class | Route to the CE mark | Notified body |
|---|---|---|
| Class A | Self-declaration after preparing the technical documentation | No |
| Class A sterile | Annex IX or Annex XI, limited to sterility | Yes, sterility only |
| Class B | QMS audit plus sampled technical documentation per device category | Yes |
| Class C | QMS audit plus technical documentation per generic device group | Yes |
| Class D | Full review of every device, EU reference laboratory testing and batch verification | Yes |
Legacy devices may use the extended transition periods. See the IVDR transition timeline.
Common Challenges in In Vitro Diagnostic CE Marking
One of the biggest challenges IVD manufacturers face is meeting the strict requirements for performance evaluation and technical documentation, especially for Class C and Class D devices. These devices need strong scientific evidence, detailed analytical and clinical performance data, and a thorough notified body review.
Many manufacturers find it difficult to collect the required clinical data, prepare compliant documentation and manage the review process. We also see many manufacturers without the know-how to plan and run these studies in real time.
As a result, expert regulatory consultants are often needed to obtain the CE mark successfully. See how our IVDR consultants work.
Plan the timeline and budget
IVD CE marking typically takes 12 to 16 months, depending on the class, documentation readiness, testing needs and notified body review times.
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One Partner for Your IVDR Compliance
From classification to notified body certificate, our IVDR consultants prepare the documentation and evidence your IVD needs and coordinate every step with the notified body.
- Technical documentation and PER
- ISO 13485 implementation and risk management
- PMS and PMPF documentation
- Notified body coordination and EU representative
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IVD CE Marking: Frequently Asked Questions
What is the difference between IVDD and IVDR?
The IVDD (98/79/EC) was the previous European directive for IVD devices. The IVDR (EU) 2017/746 is the current regulation, with much stricter requirements for technical documentation, performance evaluation, risk management, PMS and PMPF, and notified body involvement. See IVDD to IVDR.
Is ISO 13485 mandatory under the IVDR?
The IVDR does not explicitly require ISO 13485 certification, but an EN ISO 13485 quality management system is strongly recommended and generally expected during notified body assessments.
Does every IVD device require a notified body review?
No. Non-sterile Class A IVDs can be self-declared. Class B, C, D and sterile Class A devices need assessment by a notified body.
How long does IVD CE marking take?
It depends on the device class, documentation readiness, testing requirements and notified body review times. The process typically takes 12 to 16 months.
What are the IVDR classification categories?
IVDs are classified as Class A, B, C or D, depending on the intended purpose and the risk associated with the device.
What is an IVD device?
An IVD is a device, instrument or software used to examine samples taken from the human body, such as blood, urine or tissue, to give information about health conditions. Examples include blood glucose test kits, COVID-19 tests, pregnancy tests, PCR diagnostic kits and haematology analysers.
Page updated on 1st November 2026 by I3CGLOBAL QARA Team