CE Marking for IVD Devices under EU IVDR: Class A, B, C & D
We take your in vitro diagnostic device from classification to CE certificate under EU IVDR 2017/746: technical documentation, performance evaluation, PMS and PMPF planning and Notified Body coordination, so your IVD reaches the EU market without avoidable delays.
What is CE marking for IVD devices?
CE marking for IVD devices shows that your in vitro diagnostic device meets the General Safety and Performance Requirements of the EU In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746. It replaced the IVD Directive (98/79/EC) on 26 May 2022.
The biggest change is Notified Body involvement. Under the IVDD most IVDs were self-declared. Under IVDR, Class B, C and D devices, and sterile Class A devices, all need a Notified Body to audit the quality system and review the technical documentation.
Which IVDR conformity route applies to your device?
Classification under Annex VIII decides who assesses your IVD and how deep the review goes. Timelines are typical and depend on the number of models, file readiness and the Notified Body queue.
| Class | Example devices | Conformity route | Notified Body | Typical timeline |
|---|---|---|---|---|
| Class A | Specimen receptacles, general lab reagents, buffer solutions, instruments | Self-declaration (sterile Class A: Notified Body for sterility) | No (yes if sterile) | 3–6 months |
| Class B | Pregnancy, fertility, cholesterol and glucose self-tests, urine test strips | Annex IX QMS audit + technical documentation sampled per category | Yes | 8–10 months |
| Class C | Cancer markers, genetic tests, companion diagnostics, STI tests | Annex IX QMS audit + technical documentation sampled per generic device group | Yes | 10–12 months |
| Class D | HIV, hepatitis B and C screening, blood grouping (ABO, Rh) | Annex IX full QMS + technical documentation review for each device, plus EU reference laboratory testing | Yes | About 14 months |
How an IVD gets CE marked under IVDR, step by step
How we take an IVD from first assessment to CE certificate and beyond.
- 1
Classify the device
Annex VIIIWe confirm intended purpose and apply the seven IVDR rules to fix the class and conformity route.
- 2
Gap analysis & QMS
ISO 13485:2016We check your IVDD files against IVDR and set up or upgrade your quality management system to meet Article 10.
- 3
Technical documentation
Annex II & IIIWe prepare the device description, GSPR checklist, risk file, analytical and stability data, labels, IFU and PMS documentation.
- 4
Performance evaluation
Article 56 · Annex XIIIWe write the performance evaluation plan and report covering scientific validity, analytical and clinical performance.
- 5
Notified Body assessment
Class B, C, D, AsWe help you choose a Notified Body, prepare for the QMS audit and answer technical documentation questions. Class D also involves EU reference laboratory testing.
- 6
Certificate, DoC & registration
CE markYou sign the EU Declaration of Conformity and affix the CE mark. We complete UDI, EUDAMED registration and, for non-EU makers, EU Authorised Representative appointment.
- 7
Post-market surveillance
OngoingWe keep you compliant with PMS plans, PMPF, PSURs (Class C and D) or PMS reports (Class A and B), vigilance and surveillance audits.
What goes into IVDR technical documentation?
IVDR transition deadlines for legacy devices
Regulation (EU) 2024/1860 extended the transition, but only for manufacturers who meet the conditions. These are the dates that matter.
| Class | Notified Body application by | Signed agreement by | End of transition |
|---|---|---|---|
| Class D | 26 May 2025 | 26 September 2025 | 31 December 2027 |
| Class C | 26 May 2026 | 26 September 2026 | 31 December 2028 |
| Class B & sterile Class A | 26 May 2027 | 26 September 2027 | 31 December 2029 |
An IVDR quality management system had to be in place by 26 May 2025 for all classes.
Our IVD CE marking services
CE marking for IVD devices: FAQs
How long does IVDR CE certification take?
It depends on class, the number of models and variants, and how ready your file is. As a guide, Class B takes about 8 to 10 months, Class C about 10 to 12 months and Class D about 14 months from Notified Body application to certificate.
Which IVDs need a Notified Body under IVDR?
All Class B, C and D devices, and sterile Class A devices for their sterility aspects. Around 80% of IVDs now need a Notified Body, compared with about 20% under the old IVDD.
What are the IVDR transition deadlines for legacy devices?
Under Regulation (EU) 2024/1860, legacy IVDs can stay on the market until 31 December 2027 (Class D), 31 December 2028 (Class C) or 31 December 2029 (Class B and sterile Class A), provided the manufacturer has an IVDR quality system and has applied to a Notified Body by the set dates.
What is the difference between IVDD and IVDR?
IVDR introduces a risk-based classification with seven rules, much wider Notified Body involvement, stricter performance evaluation requirements, a Person Responsible for Regulatory Compliance, UDI, EUDAMED registration and tighter post-market surveillance.
What is a Performance Evaluation Report?
The PER documents scientific validity, analytical performance and clinical performance for your IVD, as required by Article 56 and Annex XIII. It is updated throughout the device lifecycle with post-market performance follow-up (PMPF) data.
Do non-EU IVD manufacturers need an EU Authorised Representative?
Yes. Under IVDR Article 11, manufacturers based outside the EU must appoint an EU Authorised Representative before placing an IVD on the EU market.
Not sure which IVDR route your device needs?
Send us your IVD details using the form below and we'll confirm its class and conformity route at no cost.
