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EU MDR Preparation: Seize the Market Opportunity and Avoid the Bottleneck

BEST PRACTICES SESSION ROOM  | Wednesday, June 13 | 1:30 pm - 2:30 pm
Speaker: Michael Wolf, Director of Solutions Delivery, Maetrics



    While all attendees will benefit from this session, the check marks indicate the skill level and roles that this session targets.
    √ Beginner  |   Intermediate  |  √ Advanced

√ Product Management
 √ Purchasing
 √ Quality Control
 √ Regulatory/Clinical Affairs
√ Research/Development/Design
 Supply Chain Management



The new EU Medical Device Regulation (MDR) is the single largest change to medical device regulations in Europe since the 1993 introduction of CE Marking. As grandfathering of existing products is not permitted, the new regulations affect all medical devices sold throughout Europe. There is a temptation for medical device companies to think that the transition arrangements through 1Q20 under MDR leave a considerable amount of time to ensure compliance. Maetrics’ recent research predicts that companies that do not address MDR early will suffer from potential bottlenecks among Notified Bodies for certification completion and capacity shortages by compliance professionals in the preparatory process. If you have not started to plan for the transition, now is the time to act. This presentation will take you through the main regulation changes and outline key requirements affecting manufacturers moving forward.

Attendee Takeaways

  1. Understand key steps companies can take to effectively implement MDR
  2. Learn how to effectively work with your Notified Body
  3. Know how to achieve business improvements in the process



Wolf 200x200Mike Wolf, Director of Solutions Delivery at Maetrics, has more than 25 years of in-line management and consultation roles. Mr. Wolf has helped organizations design, implement and improve Quality Management Systems and processes and achieve and maintain regulatory compliance, including market clearance for new devices and related international licenses or product registrations. Mr. Wolf recently served as Regulatory Subject Matter Expert within a large-scale improvement project at a global orthopaedic device company, leading the legacy review and remediation of Labelling, Regulatory Assessment and Premarket Product Launch processes and records.


Related reading from BONEZONE®: 
Your EU Medical Device Regulation Guide