The EU In Vitro Diagnostic Regulation (IVDR) 2017/746 imposes significantly stricter requirements than its predecessor IVDD. If you manufacture or import IVD devices into Europe, the deadlines are active and compliance is not optional.
The EU In Vitro Diagnostic Regulation 2017/746 replaces the old IVDD 98/79/EC and introduces far stricter requirements for IVD manufacturers. Most IVDs have moved to a higher risk class, requiring Notified Body involvement for the first time.
Four device classes. IVDR introduces Class A, B, C and D replacing the old List A, List B and self-test categories. The majority of IVDs that were self-declared under IVDD now require Notified Body certification under IVDR.
Performance evaluation mandatory. IVDR requires a full performance evaluation plan and report — scientific validity, analytical performance and clinical performance must all be documented for every device, regardless of class.
EUDAMED registration mandatory. All IVD manufacturers and EU Authorised Representatives must be registered in EUDAMED before any device can be placed on the EU market.
Post-market performance follow-up. IVDR mandates ongoing PMPF studies and periodic summary updates for Class B, C and D devices — a permanent ongoing obligation.
The IVDR transition deadlines are staggered by device class. Class D devices — highest risk, including blood grouping and HIV tests — had a mandatory transition deadline of 26 May 2025. Class C devices must comply by 26 May 2026. Class B and general self-tests must comply by 26 May 2027.
If your IVD device has not transitioned to IVDR by its applicable deadline, it cannot legally be placed on the EU market. There are no further extensions.
IVDR device classification. We classify your IVD under Annex VIII of IVDR 2017/746 and identify your conformity assessment route, Notified Body requirements and documentation obligations.
EU Authorised Representative. Non-EU IVD manufacturers must appoint an EU AR before placing any device on the market. We serve as your EU AR across all 27 member states under both MDR and IVDR.
Performance evaluation support. We prepare or review your performance evaluation plan and report, including scientific validity assessment, analytical performance data and clinical performance evidence.
Technical documentation. We prepare or review your Annex II and III technical documentation to ensure full IVDR compliance before Notified Body submission.
EUDAMED registration. We handle complete EUDAMED actor registration, SRN assignment and IVD device linkage on your behalf.
Under IVDD approximately 80% of IVDs were self-declared by manufacturers. Under IVDR only Class A devices can be self-declared — all Class B, C and D devices require Notified Body involvement. This is the single most significant operational change for IVD manufacturers entering the EU market.
NordMDR AB provides EU Authorised Representative services, EUDAMED registration and IVDR technical documentation support for IVD manufacturers worldwide. Fixed fees, 5-day onboarding.
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