EU MDR & EU IVDR Compliance Services

EU MDR & EU IVDR Compliance Services

We provide end-to-end regulatory compliance support for medical device and in-vitro diagnostic manufacturers under EU MDR (Regulation (EU) 2017/745) and EU IVDR (Regulation (EU) 2017/746), with a strong focus on complete, consistent, and Notified Body–ready technical documentation. We support manufacturers across the full product lifecycle, from transition and gap assessments to post-market compliance, ensuring alignment with Annex II and Annex III requirements. Our expertise covers device classification, intended purpose and claims justification, GSPR compliance, risk management, clinical or performance evaluation, and post-market surveillance documentation. By integrating regulatory strategy, clinical evidence, risk-benefit analysis, and post-market data, we help reduce regulatory risk, enable smoother transitions from MDD to MDR and IVDD to IVDR, and ensure sustained EU market access.

EU MDR Compliance Services (Medical Devices):
- MDR Gap Assessment and MDD → MDR Transition Strategy
- Device Classification and MDR Rule Justification
- EU Technical Documentation / Technical File / STED (Annex II & III)
- Device Description, Specifications, and Intended Purpose
- GSPR Checklist and Evidence Mapping
- Risk Management File per ISO 14971
- Clinical Evaluation Plan (CEP) and Clinical Evaluation Report (CER)
- Biological Evaluation Report (BER) per ISO 10993 (as applicable)
- Post-Market Surveillance (PMS) Plan and PMS Report
- Post-Market Clinical Follow-up (PMCF) Plan and PMCF Evaluation Report
- Periodic Safety Update Report (PSUR)
- Vigilance Reporting and FSCA Support
- Labeling, IFU, and UDI Documentation Review
- Notified Body Submission and Deficiency Response Support

EU IVDR Compliance Services (In-Vitro Diagnostic Devices):
- IVDR Gap Assessment and IVDD → IVDR Transition Strategy
- IVD Classification and Rule Justification per IVDR
- IVDR Technical Documentation / Technical File / STED (Annex II & III)
- Device Description, Intended Purpose, and Claims Justification
- GSPR Checklist and Compliance Mapping
- Risk Management File per ISO 14971 (IVD application)
- Performance Evaluation Plan (PEP) and Performance Evaluation Report (PER)
- Scientific Validity Documentation
- Analytical Performance Evaluation Documentation
- Clinical Performance Evaluation Documentation
- Post-Market Surveillance (PMS) Plan and PMS Report
- Post-Market Performance Follow-up (PMPF) Plan and PMPF Evaluation Report
- Periodic Safety Update Report (PSUR)
- Vigilance Reporting and FSCA Support
- Labeling, IFU, and UDI Documentation Review
- Notified Body Submission and Technical Deficiency Response Support