The EU-MDR Transition Meeting the CE Mark Deadline
If you plan to continue putting devices on the European market, you’ll need to implement the EU-MDR.
Due to the slow progress in the EU companies are being guided through a soft transition plan.
Dan O’Leary — industry expert with more than 30 years of experience in quality, operations and program management — explains the hybrid system, where you maintain a device certificate under the MDD and a QMS under the MDR.
The EU-MDR Transition: Meeting the CE Mark Deadline explains how to take advantage of the soft transition to the new regulation. The soft transition allows companies to retain certain aspects of the current CE Mark applications while following new registration requirements, if their notified bodies approve.
But, what does that really mean?
This report breaks down all the rules and explains all the implications of a soft transition, providing a path to follow to full compliance:
Transition Timeline: All the dates and deadlines on the transition timeline
SOPs: How to develop an SOP for the post market surveillance you will have to conduct under EU-MDR
Adverse Events: How to report adverse events
Forms: What new forms will be required
Technical documentation: How to structure technical documentation for your hybrid system
You’ll also get a set of valuable tools to help you set up a compliant system — including checklists and instructions for:
Device registration and economic operator registration
Preparing for market surveillance by Competent Authorities
Meeting post market surveillance requirements
Assigning unique device identifiers
Maintaining adverse event vigilance and reporting
Start implementing the hybrid MDD/MDR system to keep your products on the European market until the full EU-MDR comes into effect.
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Note: This publication will be available in PDF format by July 26, 2019.
About the Author
Dan O’Leary is president of Ombu Enterprises LLC, a company offering training and execution in operational excellence focusing on analytic skills and a systems approach to operations management. Mr. O’Leary has 30+ years’ experience in quality, operations, and program management in regulated industries including medical devices and clinical labs. He is an ASQ certified Biomedical Auditor, Quality Auditor, Quality Engineer, Reliability Engineer, and Six Sigma Black Belt; and is certified by APICS in Resource Management.
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