Consequences of medical device company not following regulations

In the EU market, it is not possible to place a medical device on the market without previously independent body checks.

In Medical device regulation MDR 20175/745, Article 5 – Placing on the market and putting into service is stated that the device may be placed on the market or put into service only if it complies with this Regulation when duly supplied and properly installed, maintained, and used in accordance with its intended purpose.

For more information, see:

• EU MDR Article 5 - https://advisera.com/13485academy/mdr/placing-on-the-market-and-putting-into-service/

So, all medical device regards the classification must be in compliance with MDR. Also, a new requirement in the MDR is that Manufacturers of devices, shall establish, document, implement, maintain, keep up to date and continually improve a quality management system that shall ensure compliance with this Regulation in the most effective manner and in a manner that is proportionate to the risk class and the type of device.

For further information, see:

• EU MDR Article 10 -  General obligations of manufacturers - https://advisera.com/13485academy/mdr/general-obligations-of-manufacturers/

The Standard that supports this quality system is ISO 13485:2016

Following articles you may find useful:

• How can ISO 13485 help with MDR compliance? - https://advisera.com/13485academy/blog/2020/03/09/how-can-iso-13485-help-with-mdr-compliance/
• What is ISO 13485? - https://advisera.com/13485academy/what-is-iso-13485/