Infographic: EU MDR vs. MDD – What has changed?
Kristina Zvonar Brkic
The Medical Device Directive (MDD) was first published in 1993. Since then, it has remained unchanged, although different European standards...
The Medical Device Directive (MDD) was first published in 1993. Since then, it has remained unchanged, although different European standards and guidance (particularly MEDDEV) have been continuously updated during this almost 30 years. Very often,...
How to comply with the MDR requirements for medical device labels
According to the definitions in the European Union’s Medical Device Regulation (MDR) (Article 2), “label” means any written, printed, or...
According to the definitions in the European Union’s Medical Device Regulation (MDR) (Article 2), “label” means any written, printed, or graphic information appearing either on the device itself, or on the packaging of each unit...
What are EU harmonized standards?
If you are a manufacturer in the European Union, it can be difficult to try to align the different standards...
If you are a manufacturer in the European Union, it can be difficult to try to align the different standards in the various countries. As it turns out, the EU has released a list of...
MDR compliance, and how ISO 13485 can help with it
Updated: October 26, 2023. MDR compliance refers to adherence to the European Union Medical Device Regulation 2017/745 (EU MDR 2017/745)...
Updated: October 26, 2023. MDR compliance refers to adherence to the European Union Medical Device Regulation 2017/745 (EU MDR 2017/745) by medical device manufacturers. It involves meeting the necessary regulations and requirements to ensure the...
