IVDR Compliance Support for In Vitro Diagnostics
Navigating EU IVDR Compliance: Challenges & Solutions
The EU In Vitro Diagnostic Regulation (IVDR) imposes stringent requirements for technical documentation, clinical evidence, post-market surveillance, and supply chain transparency. TS Quality and Engineering delivers end-to-end support to align your IVD products with IVDR mandates, ensuring uninterrupted market access in the EU and post-Brexit UK.
KEY IVDR COMPLIANCE INSIGHTS:
- Transition deadlines for legacy IVDs under IVDR (2025–2028)
- Enhanced clinical performance evaluation requirements
- Class-based conformity assessment pathways (Class A to D)
- Role of Notified Bodies for Class B, C, and D devices
- Dual compliance for UKCA (MHRA) and EU IVDR markets
TS Quality and Engineering’s IVDR Support Framework
1. Technical Documentation & Clinical Evidence
- Gap Analysis: Identify deficiencies in existing technical files against Annex II and III requirements.
- Clinical Performance Studies: Design and validate studies to meet IVDR’s heightened evidence standards.
- Performance Evaluation Reports (PER): Develop robust PERs with scientific validity and analytical accuracy data.
2. Post-Market Surveillance (PMS) & Vigilance
- Proactive PMS plan development aligned with Annex XIII.
- Trend reporting, incident management, and Corrective Action/Preventive Action (CAPA) coordination.
3. Supply Chain & Quality Management
- Supplier audits and EUDAMED registration support.
- ISO 13485:2016 integration with IVDR-compliant QMS processes.
4. UKCA Transition Strategy
- Parallel compliance planning for EU IVDR and UKCA requirements.
- UK Responsible Person (UKRP) services for MHRA registration.
IVDR Compliance Roadmap
| Step | TS Quality and Engineering Support |
| Classification & Gap Assessment | Device classification review; gap analysis against IVDR. |
| Technical Documentation | PER, clinical evidence, and risk management updates. |
| Notified Body Engagement | Liaise with EU Notified Bodies for Class B–D devices. |
| Labeling & UDI Compliance | Review labeling for IVDR symbols, UDI-DI/UDI-PI integration. |
| Post-Market Obligations | Establish PMS plans, periodic safety update reports. |
Why Partner With TS Quality and Engineering?
- Dual-Region Expertise: Representatives in the UK and the EU streamline EU IVDR and UKCA compliance.
- Proven Methodology: 98% success rate in IVDR technical file submissions for Class C/D devices.
- End-to-End Solutions: From clinical evaluations to EUDAMED registration and post-market audits.
- ISO 13485 Alignment: Integrate IVDR compliance with your existing QMS for audit readiness.
IVDR Compliance Checklist
☑ Device classification confirmed per IVDR Annex VIII
☑ Performance evaluation plan aligned with Annex XIII
☑ Notified Body contract secured (if applicable)
☑ Technical documentation updated with clinical evidence
☑ PMS system and vigilance protocols implemented
Contact TS Quality and Engineering
Ensure your IVDs meet EU IVDR and UKCA deadlines with our precision-driven compliance strategies.
