Compliance walkthrough
How to comply with the EU IVDR (Regulation 2017/746): video walkthrough
A walkthrough of preparing in vitro diagnostics for the EU market under Regulation (EU) 2017/746, from classification to the declaration of conformity and CE mark.
Key takeaways
- The IVDR applies to any manufacturer placing IVDs on the EU market.
- Seven Annex VIII rules sort devices into classes A to D.
- A notified body is involved for class B, C and D and sterile class A devices.
- Performance evaluation covers scientific validity, analytical and clinical performance.
- The manufacturer signs the declaration of conformity and affixes the CE mark.
The EU law for in vitro diagnostics
The IVDR is the European Union's law for in vitro diagnostics: reagents, kits, calibrators and controls, analysers, software, specimen receptacles and self-tests used to examine samples taken from the human body. It applies directly in every Member State to any manufacturer placing such a device on the EU market, wherever it is based, and it replaced Directive 98/79/EC on 26 May 2022.
Its central change is risk-based classification. Seven rules sort each device into class A, B, C or D, and a notified body is now involved for every class B, C and D device and for class A devices placed on the market sterile, so many tests that were self-declared under the Directive now need that assessment. There is no IVDR certificate as such: the manufacturer signs the declaration of conformity and affixes the CE mark. This short film walks through how a manufacturer prepares.
Classify, build the evidence, then apply
Classify each device and fix the route: its intended purpose, the Annex VIII rule and class, the conformity assessment route, the economic operators involved and any legacy date under the transitional provisions. The class decides how closely a notified body looks.
The manufacturer then builds the quality management system, the performance evaluation, covering scientific validity, analytical performance and clinical performance, and the technical documentation, with post-market surveillance and performance follow-up planned from the start. Unique device identification, registration in EUDAMED and the person responsible for regulatory compliance are put in place. Where a notified body is involved, the manufacturer applies to one designated under the IVDR whose scope covers the device; the notified body assesses and certifies, and the declaration and CE mark then follow. Notified bodies read the files against the Regulation, the harmonised standards and the guidance of the Medical Device Coordination Group.
Sterling's expert and experienced consultants prepare the classification, the QMS, the performance evaluation, the files and your team under Sterling OS™. The transition has been extended by later regulations, and a simplification proposal awaits adoption, so dates should be confirmed for each device.
EU IVDR 2017/746 at a glance
- Purpose
- CE marking of in vitro diagnostics for the EU, on performance evidence, a quality system, traceability and post-market follow-up
- Relevant to
- IVD manufacturers anywhere selling into the EU, their authorised representatives, importers, distributors and suppliers, and health institutions making their own tests
- Edition
- Regulation (EU) 2017/746, in application since 26 May 2022, with its transition extended by Regulations (EU) 2022/112 and 2024/1860; a simplification proposal of December 2025 still awaits adoption
- Certification
- No "IVDR certificate" as such. A notified body designated under the IVDR is involved for class B, C and D and sterile class A devices; plain class A is self-declared. The manufacturer signs the declaration of conformity and affixes the CE mark
- Sterling's role
- Classification, QMS, performance evaluation, technical documentation, PRRC support, UDI and EUDAMED, internal audit and notified body readiness with your team, Effivity, training, then Sustain™
- Cost and timing
- Total investment for EU IVDR compliance depends on the current maturity of your processes, the scope, locations and number of employees. The process typically takes 6 to 18 months, with the notified body's own review for classes B, C and D on top
EU IVDR 2017/746: questions people ask
Is there such a thing as EU IVDR certification?
Not in the sense of an ISO certificate. What the market requires is the CE mark, which the manufacturer affixes under its own EU declaration of conformity. For every class except plain class A, a notified body takes part and issues the certificates that declaration relies on. An "IVDR certificate" sold by a consultant or a management-system certification body is not one of them.
Which IVDs need a notified body under the IVDR?
All class B, C and D devices, and class A devices placed on the market sterile. Plain class A devices, such as IVD instruments, specimen receptacles and certain general laboratory products, are self-declared. The class comes from the seven Annex VIII rules applied to the intended purpose, and deciding it is the manufacturer's responsibility.
Does our ISO 13485 certificate make us IVDR compliant?
No, although it is the right foundation. EN ISO 13485:2016 with A11:2021 was harmonised under the IVDR in 2022, which gives a presumption of conformity only for the requirements it addresses. Performance evaluation and PMPF, UDI, the PRRC, PSURs, vigilance reporting and EUDAMED sit outside it. Its certificate is issued under accreditation, not under a notified body designation.
What are the legacy deadlines for IVDs?
Under Regulation (EU) 2024/1860, devices covered by a Directive 98/79/EC certificate and class D devices may stay on the market until 31 December 2027, class C devices until 31 December 2028, and class B and sterile class A devices until 31 December 2029. The conditions: continued compliance with the Directive, no significant change in design or intended purpose, no unacceptable risk, an Article 10(8) quality management system by 26 May 2025, an application by 26 May 2025 (certificate holders and class D), 26 May 2026 (class C) or 26 May 2027 (class B and sterile class A), and a written agreement with the notified body by 26 September of that year. IVDR surveillance, vigilance and registration rules already apply, and the sell-off date has gone.
How are class D devices treated differently?
They receive the closest scrutiny. Where the Commission has designated an EU reference laboratory for the device category, it verifies the performance claimed and tests batches; the first laboratories, designated by Implementing Regulation (EU) 2023/2713, took up these tasks on 1 October 2024 for markers of hepatitis and retrovirus, herpesvirus, bacterial and respiratory virus infections. Without a designated laboratory, notified bodies may still certify. Experts are consulted for a first-of-type device with no common specifications, and each batch is released through the notified body.
Keep exploring
Related to this video
The complete guide
Everything on EU IVDR 2017/746
Start with the EU IVDR 2017/746 page, or go straight to the guide you need.
On the EU IVDR 2017/746 page
- What are the main EU IVDR requirements?
- How do you get CE marked under the EU IVDR?
- How much does EU IVDR compliance cost?
- How long does EU IVDR compliance take?
- Who needs to comply with the EU IVDR?
- How EU IVDR compliance protects market access and the results clinicians rely on
- Frequently asked questions about the EU IVDR
Often combined with EU IVDR 2017/746
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