Regulation (EU) 2017/745 is the new regulation of the European Union on medical devices for patient use. It repeals Directive 93/42/EEC, which concerns medical devices, and Directive 90/385/EEC, which concerns active implantable medical devices, on 26 May 2021.
The new medical device regulation (MDR) was largely driven by the need to safeguard patient safety in response to technological progress. As medical devices become increasingly advanced and therefore complex, there is usually a higher risk to the patient. An important aspect of the new regulation aims to tackle this issue by redefining and reclassifying medical devices. This tightens regulations around 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 categorize devices into 4 classes: I, IIa, IIb and III. How they are classified depends on 23 rules that consider their function, the risk to patients and the manufacturer’s intended use. There are specific classification rules for four different categories of medical devices: non-invasive, invasive, active and special rules for innovative devices that include other substances. The class is dictating the manufacturing requirements, clinical evaluation and conformity assessment.
Regulation is primarily concerned with enabling patient access to high quality, safe and effective medical devices which is PROTEOR’s number one priority. These new measures help us guarantee greater traceability and transparency across our supply chain with partners and suppliers who share our values.
All PROTEOR’s technical files and documentation have been reviewed and amended to reflect the new regulation requirements and we are proud to display our MDR compliance. This is reflected in our iCatalog by accessing to the updated Instructions For Use (IFU) and Declarations of Conformance .
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Feel free to reach out to us if you require any further information!