29 April 2020
Vendlet is compliant with the new European Medical Device Regulation that poses stricter requirements for manufacturers of medical devices.
Vendlet has invested a significant amount of time and resources to ensure full compliance with the new and stricter demands of the European Medical Device Regulation (MDR).
The new demands for manufacturers of medical devices include an increased focus on traceability, documentation, risk management and post-market surveillance, to increase patient safety, which has always been close to our hearts. Therefore, our Quality & Development department has worked hard to ensure that we are compliant with the new regulations of the MDR and will continue to do so.
“It is important for us to be compliant with the new regulation, not only so that our customers and business partners can be assured that our products are safe and of the highest quality, but also so that we live up to our own standards. An increased traceability is an advantage for the customers as well as for our own processes,” says Annika Matzen, Quality & Compliance Manager at Vendlet.
New efforts at Vendlet include an increased focus on technical documentation, implementation of a Quality Management System based on ISO 13485:2016 as well as a system for traceability together with improvement of various quality processes.
At Vendlet, we welcome the new and stricter demands enforced by the MDR, as patient safety has always been at the forefront of our business. The new Medical Device Regulation replaces the previous Medical Device Directive (MDD), which Vendlet is still compliant to.
MDR was scheduled to be enforced by May 2020 but has been postponed until 2021. However, this will not influence Vendlet’s work with the regulation, as we have already implemented it.
Read more about the new regulation European Medical Device Regulation (EU)2017/745.
Vendlet is MDR Compliant