MDR (Medical Device Regulation)

The Medical Device Regulation (Regulation (EU) 2017/745) sets the rules for placing medical devices on the European market, replacing the previous directive. Under MDR, a medical device is defined as any instrument, apparatus, software, implant, reagent, material or other article intended by the manufacturer for a medical purpose—such as diagnosis, prevention, monitoring, treatment, or alleviation of disease—so long as its principal intended action is not achieved by pharmacological, immunological, or metabolic means. 

MDR imposes strict requirements in areas including clinical evaluation, risk management, quality management systems, post-market surveillance, traceability, and transparency (including registration in EU databases).

Under the Medical Device Regulation (MDR 2017/745), devices are classified based on risk:

• Class I: Low risk (e.g., stethoscopes, bandages)
• Class IIa: Low-to-moderate risk (e.g., dental fillings, infusion pumps)
• Class IIb: Moderate-to-high risk (e.g., ventilators, bone fixation plates)
• Class III: Highest risk (e.g., heart valves, implantable defibrillators)

Software is classified mainly under Rule 11, which often places diagnostic or therapeutic software in Class IIa or IIb.