June 17, 2019 - June 21, 2019
/ Europe - Belgium - Brussels
Date: June 17 - 21, 2019
Duration: 5 days
Location: Brussels, Belgium
Gert Bos, Executive Director & Partner of Qserve Group, is invited as panel speaker at the MedTech Summit EU MDR & IVDR: The Final Countdown. Talking regulatory and clinical strategies, PMS & vigilance, legal, combination products, sterilization and emerging market requirements.
June 17, 12:10 - 12:55 PM
Panel discussion: Beyond March 2019: Brexit and the MDR – what does it mean for implementation?
- Understanding how Competent Authorities will approach Brexit
- Understanding how Brexit will impact industry’s relationship with Competent Authorities
- Clarifying Notified Body procedures and representatives based in the UK
- Providing clarification on the position Authorised Representatives based in the UK
- Examining the extent has Brexit is changing the way industry are preparing for implementation
June 17, 14:15 - 15:00 PM
Notified Body Panel Discussion: An update on Notified Body designation: Scope, resource and timelines
- Clarifying the timelines for Notified Body designation
- Assessing Notified Body capacity and resource: how big is the window and will MDD certificates be extended?
- Will your Notified Body have the scope? Understanding if and when your Notified Body will be able to re-certify your products
- How will Notified Body delays impact certificates up for renewal and clarifying what will happen if certificates don’t get issued in time
- What happens if your Notified Body goes out of business? When and how to switch your notified body
June 18, 16:25 - 17:25 PM
Panel Discussion: Global convergence of regulatory requirements: challenges opportunities and looking to the future
- Safeguarding the health of patients and users while avoiding unnecessary burdens on manufacturers
- Clarifying the key differences between EU and US medical device legislation and assessing opportunities for harmonization
- International acceptance and planning: Understanding how the ROW accept the MDR
- Feedback from IMDRF
For the full program details and registration, please visit the official website.
With offices in the USA, Europe, and China we are an essential partner for medical device manufacturers. With our global team of multilingual consultants, Qserve's expertise and experience provide international support, on a local level.