MDR

The regulation applies to manufacturers, importers, and authorized representatives who place medical devices on the market in the EU – ranging from simple dressings to implants and complex diagnostic technology. This affects both established medical technology companies and smaller manufacturers and suppliers who, as part of the supply chain, must provide technical documentation and proof of conformity.

• Risk Classification: classification into Class I, IIa, IIb, or III based on risk potential

• Clinical evaluation: demonstration of safety and performance based on clinical data throughout the product lifecycle

• Technical documentation: comprehensive, product-specific evidence in accordance with Annexes II and III

• UDI (Unique Device Identification): unique product identification for seamless traceability

• Post-market surveillance: Systematic monitoring of the product after market introduction, including a vigilance system

• Notified bodies: mandatory involvement of accredited testing bodies for Class Is/Im/Ir and higher

The MDR is directly applicable EU law that sets forth specific product requirements, risk classes, and a mandatory conformity assessment procedure for CE marking. ISO 13485, on the other hand, is a voluntary, internationally recognized standard that governs exclusively the manufacturer’s quality management system. In practice, MDR compliance is virtually impossible to achieve without a certified quality management system: A valid ISO 13485 certification therefore regularly serves as the basis on which Notified Bodies conduct the conformity assessment under the MDR.

A medical device may not be placed on the market in the EU without a valid CE marking in accordance with the MDR. For products already on the market, market surveillance authorities may order sales bans and recalls; in the event of safety incidents, Field Safety Corrective Actions must be reported. Since a defective medical device can directly endanger human life, serious violations may also result in civil and criminal consequences for manufacturers and responsible individuals.

• ISO 13485 – quality management system for medical devices

• IVDR – EU regulation on in vitro diagnostic medical devices

• FDA 21 CFR Part 820 – U.S. quality management requirements for medical mevices

• ISO 9001 – basic quality management standard