What is IVDR (EU 2017/746)?
The In Vitro Diagnostic Regulation (IVDR) is the EU legal framework for placing IVDs on the EU market. It strengthens requirements for safety and performance evidence, introduces risk‑based classification (A–D) and expands Notified Body involvement for many IVDs.
Manufacturer outside the EU?
If your company is located outside the EU, you may need EU Authorised Representative services to place products on the EU market and to respond to market surveillance requests.
EU-based manufacturer? Continue below — we can still support documentation and conformity assessment readiness.
When IVDR applies
IVDR applies to in vitro diagnostic medical devices (IVDs) and related accessories placed on the EU market. A correct assessment usually starts with:
- Product definition and intended purpose (what analyte/condition, for whom, and for what decision).
- IVD classification (Classes A, B, C, D) — see IVD classification (IVDR).
- Conformity assessment route and whether a Notified Body is required.
Key IVDR building blocks
- Quality Management System (QMS) and regulatory processes (commonly aligned with ISO 13485).
- Technical documentation demonstrating compliance (structure similar in principle to MDR, but with IVDR‑specific evidence expectations).
- Performance evaluation (scientific validity, analytical performance and clinical performance) — see Performance evaluation (IVDR).
- Risk management across the lifecycle.
- Post‑market performance follow‑up and vigilance activities.
- UDI and traceability planning (as applicable).
- EUDAMED obligations (availability depends on modules and your role).
- PRRC responsibilities (role and processes).
IVDR risk classes (overview)
Class A
Lowest risk (sterile Class A has additional requirements).
Class B
Moderate individual risk / low public health risk.
Class C
High individual risk and/or moderate public health risk.
Class D
Highest risk (high public health risk).
The exact class follows from applying the IVDR classification rules to your intended purpose and decision impact.
How to comply (practical roadmap)
- Define intended purpose and claims (clear use case and decision impact).
- Classify the IVD and confirm the conformity assessment route.
- Plan performance evaluation and evidence generation (scientific validity, analytical & clinical performance).
- Prepare technical documentation and link claims → evidence.
- QMS readiness and process implementation.
- Notified Body interaction (for many Class B/C/D IVDs).
- Maintain compliance after placing on market (post‑market activities, updates, change control).
Who are the key authorities and bodies?
European Commission & MDCG
Provide guidance and implementation support for IVDR across the EU.
Competent Authorities
National regulators responsible for market surveillance and enforcement.
Notified Bodies
Designated bodies that perform conformity assessment for many IVDs under IVDR.
Reference laboratories / common specifications
Depending on IVD type and class, additional expectations may apply (case‑by‑case).
Common problems we see (and how to avoid them)
- Unclear intended purpose → wrong class and wrong evidence plan.
- Underestimating performance evidence → delays and scope changes late in the project.
- Weak linking of claims to evidence → Notified Body questions and rework.
- QMS not audit‑ready → findings during review and slow corrective actions.
- Notified Body availability → timeline risk (plan early).
How we help
Gap assessment, roadmap, documentation readiness and coordination toward compliance.
Planning and evidence strategy for scientific validity, analytical and clinical performance.
Classification rationale and alignment of intended purpose with IVDR expectations.
