The new Regulation (EU) 2017/745 or MDR is the European medical device regulation that defines regulations and constraints that all manufacturers and distributors must comply with in order to place a medical device on the European market.
The new Regulation complements and replaces the previous Directives 90/385/EEC and 93/42/EEC, providing more stringent requirements and measures in line with the evolution of the medical device market globally.
The Regulation is a true piece of legislation, binding and obligatory towards all public and private entities, which are required to comply with EU law. This means that, compared to previous directives, all EU member states are required to comply with it without a national transposition measure.
Why was the MDR Regulation born?
The MDR Regulation was born out of the need to adapt medical device legislation to future needs in order to establish a robust, transparent and sustainable regulatory framework. Going, in this way, to harmonize the functioning of the internal market within the EU.
There is, therefore, a desire to want to strengthen post-market surveillance and traceability of medical devices by preventing the placing on the union market of devices that are potentially hazardous to public health.
The main objectives of the MDR Regulation
The European union is one of the world’s largest markets for medical devices. In fact, it accounts for 30 percent of the global medical device market with about 140 billion euros in sales in 2022.
Total sales of medical devices in the European union are expected to exceed 170 billion euros by 2027.
Why is it important to certify?
The main objectives of the Regulation (MDR) are to establish:
- Greater protection of public health
- Better control and accessibility of technical documentation
- Greater transparency and traceability of medical devices
- More comprehensive labeling through the introduction of a UDI code and reporting of device data to the European database EUDAMED.
- Addressing differences in national regulatory systems between different EU member states.
Why is it important to certify?
A medical device certified under MDR (Regulation (EU) 2017/745) demonstrates greater quality, safety, and reliability. This is because the clinical evaluations, investigations, and notified bodies that certify it are subject to tighter controls.
In addition, device information is encapsulated in the EUDAMED database, consequently the information and transparency of each device is enhanced.
Finally, once devices are placed on the market, performance data are collected from manufacturers that will improve market surveillance and vigilance over time.
Are you a manufacturer or distributor and don’t know how to submit an application for certification under MDR?
