The new Medical Device Regulation (MDR)
Regulation (EU) 2017/745 is the new regulation of the European Union on medical devices for human use. It came into force on May 26, 2021, repealing European Council Directive 93/42/EEC, concerning medical devices, and Directive 90/385/EEC, concerning active implantable medical devices.
The introduction of this new medical device regulation (MDR) was largely driven by the need to safeguard user safety in response to the technological progress achieved. As medical devices become increasingly advanced and therefore complex, there is usually a higher risk to the user. An important aspect of the new regulation aims to tackle this issue by redefining and reclassifying medical devices. This tightens regulations concerning devices that could pose risk to the human body.
Adjustments to the medical device classification system are not disruptive but require manufacturers to make some important changes. Many of these changes are a result of the old directive not considering the potential toxicity of some devices. The MDR categorizes devices into 4 classes: I, IIa, IIb and III. How they are classified depends on 23 rules that consider their function, the risk to users and the manufacturer’s intended use. There are specific classification rules for four different categories of medical devices: non-invasive, invasive, active and innovative devices that contain other substances. The class of the device dictates the requirements which must be satisfied with regard to manufacture, clinical evaluation and conformity.
The regulation is primarily concerned with enabling user access to high quality, safe and effective medical devices, which is PROTEOR’s number one priority. These new measures allow us to guarantee greater traceability and transparency at every stage in our supply chain with partners and suppliers who share our values.
All PROTEOR’s technical files and documentation have been reviewed and amended to incorporate the new requirements imposed by this regulation and we are proud to display proof of our MDR compliance. This amendment process also covers our e-catalogue, with updates now made to our Instructions For Use (IFU) and CE Declarations of Conformity.
To access the catalog: click here