Medical Device Regulation MDR 2017/745

Medical Device Regulation MDR 2017/745 – is the European regulation concerning medical devices, approved on April 5, 2017, which applies within the European Union. The regulation establishes stricter rules for the marketing, placing on the market, and use of medical devices compared to the previous regulation – the Medical Device Directive MDD 93/42/EEC. MDR was adopted to ensure a higher level of safety and effectiveness of medical devices. It has a significant impact on manufacturers, distributors, organizations conducting clinical trials, and regulatory authorities.

What is included in the European Regulation MDR 2017/745?

Change in Classification Rules: Many medical devices that were previously classified as low-risk Class I have been moved to Class IIa, and many reusable instruments have been moved to the new Class Ir and now require involvement of a notified body for conformity assessment. Additionally, products that were previously not considered medical devices are now regulated as medical devices due to high risks to user health, such as cosmetic contact lenses or hair removal lasers.

Additional Requirements for Labeling and Traceability: MDR requires additional identification of medical devices using a Unique Device Identifier (UDI), which must be applied to each batch of released devices.

EUDAMED Database: Introduction of a European database for enhanced traceability. EUDAMED is a centralized system developed by the European Commission for exchanging information and coordinating actions regarding medical devices in the European Union. It contains data on medical devices, manufacturers, distributors, authorized representatives, clinical trials, and incident reports. The EUDAMED database enhances transparency, safety, and effectiveness of medical devices on the European market.

Enhanced Market Surveillance and Unannounced Inspections: MDR provides for strengthened oversight by national authorities and the European Commission to ensure compliance with established requirements.

This is only a part of the requirements implemented in MDR. Additionally, manufacturers need to review risk analysis, clinical evaluations, and ensure that all tests and trials are conducted according to the list of harmonized EU standards. MDR 2017/745 represents a significant step towards ensuring the safety and effectiveness of medical devices on the European market. Through strict requirements and standards, it aims to protect patient and user health, increase trust in medical devices, and promote innovation in medical technologies.