CE Marking
MDD to MDR
We support medical device companies in upgrading from the Medical Device Directive (MDD) to the Medical Device Regulation (MDR) for CE marking by providing end-to-end, practical regulatory guidance. Our services cover gap analysis, MDR classification and scope assessment, technical documentation remediation, clinical evaluation and PMCF strategy, quality management system alignment, and hands-on support through notified body interactions. With a risk-based, efficient approach, we help you navigate MDR requirements smoothly, reduce approval timelines, and maintain market access while strengthening long-term regulatory compliance across the EU.
MDR Checklist
How this book serves as your EU MDR checklist
Navigating the complexities of the European Union Medical Device Regulation (EU MDR) can be a daunting task for many medical device manufacturers and stakeholders. The EU MDR, which came into full effect in May 2021, introduced rigorous standards and compliance requirements to ensure the safety and effectiveness of medical devices within the European market. To simplify the compliance process, this book has been meticulously crafted to serve as a comprehensive checklist, guiding you through each critical step required for adherence to the regulation.
Structured Guidance for Compliance The book is designed with a clear, structured approach that aligns with the EU MDR’s intricate requirements. It breaks down the regulation into manageable sections, each addressing a specific compliance aspect. From understanding the regulatory framework to detailed instructions on documentation, quality management systems, and post-market surveillance, the book provides a step-by-step guide to ensure that no critical element is overlooked. Each section is presented as a checklist item, allowing you to systematically track your progress and ensure that all regulatory obligations are met.
MDR Checklist
Part 1
MDR Checklist
Part 3