7 – 8 November 2018
Park Plaza Victoria, Amsterdam
Every medical device and medical manufacturer placing devices in the EU must comply…
Under the EU approach there is no possibility of grandfathering existing products and ultimately all legacy devices (CE Marking under the current MDD) will need to meet the full requirements of the new EU MDR by 2020, with a possible three-year grace period under strict conditions.
Registering for this workshop will have hands-on case studies exercises including:
- General safety and performance requirements (GSPR)
- Updating technical documentation
- Preparing clinical data
- Ongoing post market and post market clinical follow-up expectations
- Gap assessment and product rationalization
- Hot issues (notified body availability, Brexit, lack of guidance, expert panels and more)
20 November 2018
Radisson Blu Hotel, Brussels
The workshop will include a brief review of the changes MDR will introduce. We will also discuss the anticipated practical implications of the changes and share the concerns of all stakeholders as the regulators establish the future implementation expectations. The outcome of this unique event will be the creation of two white papers that will be inputted to the Commission and Regulators as they develop their implementation requirements.
Help create practical considerations to support consistent and addressable implementation expectations.