MDR

Medical Device Regulation

MDR - Medical Device Regulation

New regulations for medical devices: The impact of the Medical Device Regulation (MDR)

On May 26, 2021, the Medical Device Regulation (MDR) of the European Union became binding, bringing changes for all manufacturers of medical products. But what exactly do these new regulations entail?

quality-transparency-safety

Safety, Quality, and Transparency

The MDR represents a new regulation of medical devices by placing a stronger emphasis on safety, quality, and transparency. The goal is to further enhance patient safety and make the entire lifecycle of medical devices safer and more transparent. These values are achieved through stricter requirements for the clinical evaluation of medical devices. Manufacturers must now conduct even more thorough testing and monitoring of their products to demonstrate safety and performance.

Deadlines for Proper MDR Implementation

To facilitate the transition to the new regulation smoothly, certain deadlines must be observed. Manufacturers, like us, must ensure that their products comply with the requirements of the MDR and undergo the necessary approval procedures to remain authorized for market access.

For further information, please refer to Regulation (EU) 2023/607 of the European Parliament and of the Council of 15 March 2023 amending Regulations (EU) 2017/745 and (EU) 2017/746 with regard to transitional provisions for certain medical devices and in vitro diagnostic medical devices.

MDR Deadlines

The MDR introduces far-reaching changes aimed at improving the safety, quality, and transparency of medical devices. This enhances trust in the safety and efficacy of medical products.

As a manufacturer, it is our priority to continue providing our customers with safe medical devices. Therefore, we are actively working towards certification in accordance with the requirements of the Medical Device Regulation (MDR).

If you have any questions on this matter or require further information, please do not hesitate to contact us. We are at your disposal and happy to assist you.

 

Confirmation Letter  acc. (EU) 2023/607 with regard to (EU) 2017/745 >>>