Proposed MDR/IVDR amendments in practice: operational implications for manufacturers

English

Abstract:

The proposed December 2025 amendments to Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostics (IVDR) represent a significant evolution in the regulatory oversight of medical technologies in Europe. Developed in response to persistent implementation challenges, including Notified Body capacity constraints, increasing compliance costs, extended certification timelines, and concerns regarding device availability, the reforms aim to improve proportionality, predictability and operational efficiency while maintaining the core safety and performance principles of the existing MDR and IVDR frameworks.

This article by Anuja Yardi examines the proposed amendments from a practical manufacturer and operational perspective, focusing specifically on how the reforms may affect day-to-day regulatory activities, lifecycle oversight responsibilities, and regulatory operating models within medical device organisations. Key topics include certificate lifecycle management, representative technical documentation review, evolving clinical evidence expectations, Notified Body interactions, digitalisation, innovation pathways and implementation variability.

The analysis explores how the proposed transition from event-based compliance towards more continuous lifecycle oversight may affect technical documentation maintenance, clinical evaluation activities, post-market surveillance integration, regulatory data management and cross-functional coordination. It also examines operational uncertainties associated with implementation, including variability in interpretation across Notified Bodies, evolving oversight expectations and dependence on future guidance and implementing measures.

The article highlights that the proposed amendments do not necessarily reduce regulatory burden but instead redistribute regulatory effort across the product lifecycle through greater emphasis on ongoing readiness, documentation consistency, lifecycle data integration and risk-based oversight. Practical considerations are provided to help manufacturers assess organisational readiness, strengthen internal regulatory processes and prepare for a more continuous and operationally integrated approach to MDR/IVDR compliance as the European regulatory environment continues to evolve.

Learning objectives:

This article provides a practical analysis of the proposed December 2025 MDR/IVDR amendments from a manufacturer and operational perspective, drawing on the European Commission proposal, supporting documentation and recent implementation discussions. The article will help readers:

• Understand how the proposed MDR/IVDR amendments may affect manufacturer operating models, lifecycle oversight activities and day-to-day regulatory execution.
• Recognise the practical implications of proposed changes to conformity assessment, technical documentation governance, clinical evaluation and post-market surveillance processes.
• Assess how increasing digitalisation, EUDAMED expansion and evolving Notified Body interactions may influence regulatory readiness, submission planning, and data management practices.
• Identify operational risks and implementation challenges associated with the proposed reforms, including variability in interpretation, evolving oversight models and regulatory system readiness.
• Apply practical considerations from the proposed amendments to strengthen internal regulatory processes, cross-functional coordination and long-term compliance planning.

About the author:

Anuja Yardi, MS in Regulatory Affairs, MPharm, RAC (US), is a Regulatory Affairs Manager at Zimmer Biomet with over 14 years of experience across medical devices, in vitro diagnostics, pharmaceutical and human tissue-based products. Her work focuses on global regulatory strategy, FDA submissions, EU MDR/IVDR compliance, lifecycle management, and post-market regulatory operations. She has experience supporting product development, market access, regulatory due diligence activities, and complex global regulatory initiatives involving interactions with Notified Bodies and international health authorities. Beyond her corporate role, Anuja actively contributes to the regulatory profession through RAPS, publications, mentoring and participation in industry working groups through organisations including AdvaMed, MedTech Europe and AMDM.

Specification:

14 pages plus covers, in English, supplied by email as a PDF.

This article will be published in the August 2026 issue of the Journal of Medical Device Regulation.