EU MDR & IVDR Regulatory Consulting for Medical Device Manufacturers
DEMEDs supports medical device manufacturers in achieving and maintaining full compliance with the European Medical Device Regulation (EU) 2017/745 and In Vitro Diagnostic Regulation (EU) 2017/746.
From clinical evaluation to post-market surveillance, our regulatory experts provide lifecycle support for safe and compliant market access in Europe and global markets.
Our Expertise
- MDR Regulatory Strategy
- Guidance for manufacturers navigating the EU MDR regulatory framework including device classification, conformity assessment pathways, and Notified Body interaction.
- Clinical Evaluation & Clinical Evidence
- Preparation and maintenance of Clinical Evaluation documentation according to MDR Article 61 and Annex XIV.
- Technical Documentation
- Development and maintenance of MDR-compliant technical documentation according to Annex II and Annex III.
- Post-Market Surveillance
- Implementation of lifecycle monitoring including PMS plans, vigilance systems, and safety reporting.
Our Services
- MDR Gap Assessment
- Clinical Evaluation Plan (CEP)
- Clinical Evaluation
- Report (CER)
- PMCF Plans and
- Reports
- Technical
- Documentation (Annex II & III)
- Risk Management (ISO 14971 integration)
- Post-Market Surveillance (PMS)
- Periodic Safety Update Reports (PSUR)
- UDI Implementation
- EUDAMED Registration
- Support
Why DEMEDs
- Regulatory experts with extensive MDR experience
- Proven collaboration with European Notified Bodies
- Strong expertise in clinical literature review and regulatory strategy
- Lifecycle compliance support from development to post-market activities