IVDR CE Certification Consultants for IVD Manufacturers

What Is IVDR CE Certification?

IVDR CE certification is the process an in vitro diagnostic device goes through to show it meets the IVDR before being placed on the EU market. When the process is complete, the manufacturer signs an EU declaration of conformity and affixes the CE mark, followed by the notified body's four-digit number where a notified body was involved. The IVDR has applied since 26 May 2022 and replaced the old IVD Directive (IVDD).

Strictly, the CE mark is applied by the manufacturer, and the certificate is issued by an EU notified body. As IVDR consultants, we do not issue certificates. We prepare your device, documents and quality system so that the notified body review goes smoothly and your IVDR CE certification is granted without long delays.

The IVDR applies to reagents, calibrators, control materials, kits, instruments, specimen receptacles and software intended for in vitro examination of human specimens. Read the IVDR (EU) 2017/746 on EUR-Lex.

CE-IVD vs IVDR: What Changed from the IVDD?

"CE-IVD" is the label commonly used for IVDs that carry the CE mark. Under the old IVDD, around 80% of IVDs were self-declared by the manufacturer without a notified body. Under the IVDR, the situation is reversed: around 80% of IVDs need notified body review. The main changes are:

• Risk-based classification – four classes (A, B, C, D) replace the IVDD lists (List A, List B, self-test and general IVDs)
• Notified body involvement – required for Class A sterile, B, C and D devices
• Performance evaluation – stronger evidence of scientific validity, analytical performance and clinical performance
• Post-market duties – post-market surveillance, post-market performance follow-up (PMPF) and periodic safety update reports for higher classes
• Traceability – UDI and registration in EUDAMED
• People – a Person Responsible for Regulatory Compliance (PRRC) and, for non-EU manufacturers, an EU Representative

An IVD that was CE marked under the IVDD is not automatically compliant with the IVDR. It must be re-classified and re-assessed, within the transition deadlines explained below.

IVDR Classification: Class A, B, C and D

IVDR classification follows seven rules in Annex VIII, based on the intended purpose of the device and the risk to the patient and public health. The class decides the conformity assessment route and how deep the notified body review will be.

The difference between Class C and Class D is mainly about public health risk. A Class D device can affect many people at once, for example by allowing an infected blood donation into the blood supply. A Class C device mainly affects the individual patient being tested. Getting the class right is the first step of IVDR CE certification, and we confirm it with a written classification rationale.

IVDR CE Certification Requirements

To achieve IVDR CE certification, a manufacturer must meet the following key requirements:

• General Safety and Performance Requirements (GSPR) in Annex I, with a checklist showing how each one is met
• Technical documentation as described in Annex II, and post-market surveillance documentation in Annex III
• Quality management system under Article 10, usually based on ISO 13485
• Risk management in line with ISO 14971
• Performance evaluation and a Performance Evaluation Report (PER)
• Labelling and instructions for use that meet IVDR Annex I, Chapter III
• UDI assignment and registration in EUDAMED (see our UDI guide)
• Post-market surveillance plan, PMPF plan, and PSUR for Class C and D devices
• Summary of Safety and Performance (SSP) for Class C and D devices
• Person Responsible for Regulatory Compliance (PRRC) and, for non-EU manufacturers, an EU Representative

Devices for self-testing and near-patient testing also need usability evidence, and devices containing software must follow software lifecycle requirements.

Performance Evaluation Under IVDR

Performance evaluation is often the hardest part of IVDR CE certification. It is a continuous process that shows the device achieves its intended purpose and is safe. It rests on three pillars:

• Scientific validity – the link between the analyte and the clinical condition or physiological state
• Analytical performance – how accurately and reliably the device detects or measures the analyte (for example sensitivity, specificity, precision, limit of detection)
• Clinical performance – how well the device's results relate to the clinical condition in the target population

The results are summarised in a Performance Evaluation Plan and Performance Evaluation Report, and kept up to date through post-market performance follow-up (PMPF). We prepare these documents with ready-made templates, review your existing study data and tell you early if additional performance studies are needed.

IVDR CE Certification Process: Step by Step

The IVD CE marking process under the IVDR usually follows these steps:

1. Intended purpose – define the intended purpose, users, specimen type and target population.
2. Classification – classify the device under Annex VIII and choose the conformity assessment route (Annex IX, or Annexes X and XI).
3. Gap assessment – compare your current IVDD file and quality system with IVDR requirements.
4. Quality management system – update or implement your QMS to meet the IVDR.
5. Performance evaluation – complete scientific validity, analytical and clinical performance evidence.
6. Technical documentation – compile the Annex II and III technical file, labelling and IFU.
7. Notified body application – select a notified body designated for your device type and apply.
8. Notified body review – QMS audit and technical documentation assessment; for Class D, EU reference laboratory testing and possible expert panel review.
9. Certificate and CE mark – receive the IVDR certificate, sign the EU declaration of conformity and affix the CE mark.
10. Registration and post-market – register in EUDAMED and maintain post-market surveillance.

Whatever the class, the IVD CE marking process ends with the same result: a CE marked device that can be sold in all EU and EEA countries. Class A non-sterile devices skip the notified body steps, but the manufacturer must still meet all applicable requirements and keep full technical documentation.

IVDR CE Certification for Instruments, Software and Controls

Choosing a Notified Body for IVDR CE Certification

Only notified bodies designated under the IVDR can carry out IVD CE marking for Class A sterile, B, C and D devices, and there are far fewer IVDR notified bodies than under the MDR. Each one is designated for specific device types, so the first check is whether the notified body covers your IVDR codes. Other points to compare are:

• Current waiting time to start the review and typical review duration
• Experience with your technology, for example molecular tests, immunoassays or self-tests
• Fees for the QMS audit, technical documentation review and annual surveillance
• Language, location of auditors and support for your time zone

Notified bodies can be found in the European Commission's NANDO database. We help you shortlist suitable notified bodies, prepare a strong application and answer review questions, so your IVD CE marking project keeps moving.

IVDR Transition Deadlines for Legacy CE-IVD Devices

Regulation (EU) 2024/1860 gives legacy IVDs that need a notified body under the IVDR extra time, provided the manufacturer meets set conditions (an IVDR quality management system, an application to a notified body and a signed agreement by fixed dates):

• Class D: until 31 December 2027
• Class C: until 31 December 2028
• Class B and Class A sterile: until 31 December 2029

Manufacturers who miss the conditions lose the extension. European Commission Q&A on the IVDR transition

IVDR CE Certification Cost and Timeline

Our consulting fees are simple and fixed by IVDR class. Prices are in USD.

Notified body fees are paid directly to the notified body and are not included. Performance evaluation and performance studies are quoted per device. See all our MDR and IVDR fees.

The total timeline depends mainly on the notified body. Preparing the technical documentation usually takes a few months, while notified body review for Class B, C and D devices often takes 12 months or more. Starting early is the best way to protect your EU market access.

Our IVDR Consulting Services

Our IVDR consultants offer complete IVDR consulting services or support for individual steps:

Why Choose MedDeviceCorp as Your IVDR Consultants?

• Regulatory specialists focused on IVD and medical device compliance
• Simple, fixed fees by IVDR class
• Ready-made templates for performance evaluation and technical documentation
• One team for IVDR, MDR CE marking, EU Representative and US FDA requirements

IVDR CE Certification FAQs