Navigating the Regulatory Shift
The transition from the Medical Device Directives (MDD/AIMDD/IVDD) to the Medical Device Regulation (EU 2017/745) and In Vitro Diagnostic Regulation (EU 2017/746) represents the most significant regulatory change in decades.
RegOps provides strategic MDR/IVDR consulting to help you navigate this complex landscape. We assess your compliance status, develop practical transition roadmaps, and support implementation. Our consultants prioritize efforts to help you allocate resources effectively and maintain market access throughout the transition.
Our Capabilities
Comprehensive support across the entire regulatory lifecycle.
Comprehensive assessment of technical documentation and quality systems against MDR/IVDR. We identify gaps, quantify remediation effort, and develop prioritized transition plans.
Determination of device classification under MDR/IVDR key rules. We advise on conformity assessment routes, combination products, and Notified Body involvement.
Development of clinical evaluation strategies to satisfy enhanced requirements. We help establish clinical plans, equivalence justifications, and PMS/PMCF strategies.
Implementation support for Unique Device Identification and EUDAMED registration. We guide UDI assignment, labeling updates, and database submissions.
Advisory on responsibilities for manufacturers, importers, and distributors. We help establish compliant supply chain arrangements and ensure regulatory understanding.
Support for interactions including application preparation, submission, and audit prep. We help present your regulatory case effectively for efficient certification.
The RegOps Advantage
Our consultants have supported manufacturers across the device spectrum—from Class I accessories to Class III implantables. We understand both the requirements and the practical challenges.
Regulatory Depth
We maintain current knowledge of MDR/IVDR requirements, MDCG guidance, and Notified Body practices.
Practical Focus
We develop achievable transition strategies that balance regulatory ideals with implementation realities.
Cross-Functional Expertise
Compliance touches quality, clinical, and operations. We understand these interdependencies.
Legacy Device Experience
Expertise in transitioning legacy portfolios with long market histories but limited documentation.