Product Details
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.
About the Contributor
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.
Who Will Benefit
- Regulatory compliance
- Quality management
- Design engineering
- Product marketing
- Post-production specialists
- Vigilance specialists
Add to Cart
Contriubotor:
Dan O’Leary
ISBN-13:
978-1-60430-104-5
Publication date:
July 2019
Page count:
60
Multi-user Access
Save money with a license agreement allowing significant numbers of users access to an electronic version of this book. For multi-user access to multiple titles, FDAnews offers the FDAnews Books Library — a personalized collection of FDAnews publications that is fully searchable. Contact Customer Service for a quote or more information.
Our Guarantee
Not satisfied with your publication? For the PDF version, you must notify FDAnews within 24 hours of receipt of purchase and we will refund 100 percent of your purchase price.