MDR-certified! Corscience passes audit
An important endorsement of the quality and safety of our products: in March 2021, Corscience successfully passed the audit for the new Medical Device Regulation (EU) 2017/745 that was carried out by the notified body MedCert. This makes the Erlangen-based engineering specialist one of the first medical device manufacturers to already be developing MDR-compliant products.
“Since 2017, we’ve been evaluating the requirements for the MDR and continuously updating our quality management system as well as the technical files of our medical devices”, says Dr Claudius Moor, Managing Director of Corscience. “We’re also well equipped for upcoming MDR challenges and look forward to overcoming them together with our customers and partners.”
Aim and contents of the MDR
After the introduction of the MDR was delayed by one year due to the pandemic, the new EU regulation has applied since 26 May 2021. The aim is, on the one hand, to increase the quality, safety and reliability of medical devices. And on the other hand, to increase information and transparency for patients and users.
To this end, the MDR formulates, among other things, stricter requirements for clinical testing and evaluation as well as comprehensive documentation requirements: once medical devices are available on the market, manufacturers need to continuously and proactively collect data on how the device is performing.
Other highlights in the implementation are, for example, the requirement to document devices in the European Database for Medical Devices (EUDAMED) and integrate them into the process landscape, as well as introducing a Unique Device Identification (UDI): each medical device can be traced thanks to its unique labelling.