IVDR Compliance — Don’t Miss the Deadline
EU IVDR 2017/746 is now enforced. If your IVD products are not IVDR-compliant, your access to the EU market is at risk. RABT Global’s IVDR compliance specialists will assess your current status and build your fastest route to compliance — today.
Where are you on the IVDR compliance timeline? Book a 30-minute consultation and get a clear answer — free of charge.
EU IVDR 2017/746 full applicability: 26 May 2022
Extended transition deadlines (Regulation 2022/112):
- Class D IVDs: 26 May 2025 — DEADLINE PASSED for most
- Class C IVDs: 26 May 2026
- Class B IVDs: 26 May 2027
- Class A sterile IVDs: 26 May 2027
If your IVDs are not yet IVDR-compliant, time is running out. Notified Body capacity is constrained. RABT Global can fast-track your IVDR compliance programme.
RABT Global’s IVDR Compliance Pathway
Portfolio Assessment & Classification
Classify all IVDs under IVDR Annex VIII. Identify NB requirement by class. Map compliance programme timeline per device.
Gap Analysis & Remediation Plan
Assess current documentation, performance data, and QMS against IVDR requirements. Develop prioritised remediation plan.
Performance Evaluation & PMPF Planning
Plan and review analytical/clinical performance studies. Prepare Performance Evaluation Report (PER). Develop PMPF plan.
Technical Documentation Preparation
Compile IVDR-compliant technical documentation — device description, labeling/IFU, performance evaluation, risk management, QMS evidence.
Notified Body Application & Audit
Select NB with IVDR scope. Prepare and submit NB application. Support technical review and on-site audit preparation.
EUDAMED, UDI & CE Marking
Register in EUDAMED. Assign UDI. Issue Declaration of Conformity. Affix CE mark. Begin PMPF and vigilance programme.
IVDD vs EU IVDR 2017/746 — Key Changes
| Factor | IVDD (Old — 98/79/EC) | EU IVDR 2017/746 (Current) |
|---|---|---|
| Device Classification | List A, List B, Self-test, General IVDs (4 categories) | Class A, B, C, D — based on risk (22 classification rules) |
| NB Involvement | List A and B only (~20% of IVDs) | Class B, C, D (~80%+ of IVDs now need NB) |
| Performance Evaluation | Analytical & clinical performance summary | Full performance evaluation + performance studies |
| PMCF Equivalent (PMPF) | Not formalised | Post-Market Performance Follow-up (PMPF) mandatory |
| EUDAMED Registration | Not required | Mandatory for all economic operators and devices |
| Common Specifications (CS) | Not mandated | Common Specifications issued for high-risk IVDs |
| Companion Diagnostics | No specific provisions | Class D — specific requirements for CDx under IVDR |
Our EU IVDR Compliance Services
IVDR Gap Analysis
assessment of your current IVD portfolio status against IVDR 2017/746 requirements
IVDR Device Classification
systematic classification of all your IVDs under IVDR Annex VIII classification rules
Performance Evaluation
analytical and clinical performance study planning, data review, and performance evaluation report (PER) preparation
Post-Market Performance Follow-up (PMPF)
PMPF plan development and ongoing PMPF data management
IVDR Technical Documentation
preparation of complete IVDR technical file including device description, labeling, IFU, risk management
Notified Body Application & Audit Support
IVDR NB selection, application preparation, technical documentation submission, and audit readiness
EUDAMED & UDI Registration
IVD operator and device registration in EUDAMED; UDI-DI assignment and management
Common Specifications (CS) Compliance
review of IVDs subject to IVDR Common Specifications and compliance gap assessment
Companion Diagnostic (CDx) IVDR Strategy
IVDR Class D CDx compliance planning and coordination with medicinal product regulatory team
EU IVDR — Frequently Asked Questions
A: Yes. IVDR 2017/746 replaced the IVDD (98/79/EC) entirely. IVDD-compliant devices require full IVDR compliance — which includes reclassification (80%+ of IVDs move to higher classes under IVDR), new performance evaluation, updated technical documentation, EUDAMED registration, UDI, and Notified Body involvement for most devices. RABT Global’s IVDR gap analysis identifies exactly what your IVDs need.
A: Companion diagnostics (CDx) are classified as Class D under IVDR — the highest risk class — and require Notified Body involvement, consultation with EMA or national competent authority (for the associated medicinal product), and potentially review by an EU reference laboratory. RABT Global provides specialist IVDR CDx compliance advisory for manufacturers of oncology and precision medicine diagnostics.
A: A Performance Evaluation under EU IVDR is a systematic, planned process to generate, collect, analyse, and assess data on the analytical and clinical performance of an IVD. It includes literature review, analytical validation data, clinical evidence, and ongoing PMPF data. The Performance Evaluation is summarised in a Performance Evaluation Report (PER) — a core document in the IVDR technical file.
A: Yes. RABT Global can conduct an urgent IVDR compliance assessment, prioritise your compliance programme, and manage an accelerated NB application process. Early engagement with an IVDR-experienced regulatory team is critical to preserving your EU market access. Contact us immediately if your IVDR deadline has passed or is approaching.
IVDR Deadlines Are Enforced — Act Now with RABT Global
Specialist EU IVDR compliance services for IVD manufacturers. Gap analysis. Performance evaluation. NB audit support. EUDAMED. One expert team from start to CE mark.