The Medical Device Regulation (MDR)1 was approved in 2017 to replace the current Medical Devices Directive (MDD). The MDR places greater emphasis on controls, transparency, surveillance and vigilance for the medical device industry and begins to take effect in May 2020. As a result of this regulation, medical devices will need to demonstrate conformity to the regulations beginning in May 2020.
If you would like more information on EU-MDR, visit:
Edwards Lifesciences Commitment to MDR
As one of the leading medical device companies in Europe, we strongly support the new MDR, and we are taking proactive steps to meet the new requirements.In this respect, we are:
- Reviewing all our promotional materials, labels and records to ensure a smooth transition to the new rules.
- Reviewing our internal processes (e.g., research/development, clinical operations, etc.), to ensure that new technology can be made available on the EU market when appropriate.
- Working with Notified Bodies to recertify our existing portfolios.
- Developing universal implant cards that will be included with all implantable devices.
How the MDR will Impact You
During the coming months and years, we will be implementing changes. Due to the considerable amount of time, effort, and cost with being MDR compliant, you may see updates to our products, including standardization of our product lines and price increases. This is a result of us taking proactive steps to streamline our portfolio and continue to deliver to you our highly innovative and quality products in a continuous manner.
We thank you for choosing Edwards Lifesciences.
1 The MDR (EU) 2017/745, was adopted at the same time as the In-Vitro Diagnostics Regulation (EU) 2017/746.