NEW MEDICAL DEVICES REGULATIONS

The European Commission has adopted and published the new EU regulations. They will apply after three years as regards medical devices and after five years as regards in vitro diagnostic medical devices.

The regulations will strengthen patient safety and ensure the availability of new devices, which will be of benefit to patients. For manufacturers (like Tytex) this means that they must meet stricter requirements as to the quality, performance and safety of medical devices placed on the market.

Tytex A/S has analysed the new regulations thoroughly and started the process of implementing all necessary adjustments accordingly. If you have questions to this process, please contact your Key Account Manager.

Click here to read the guidance from the Danish Medicines Agency and read the regulations in full.