Info packaging

You can purchase this product from the manufacturer under the MDD only if there is a valid MDD certificate. If the manufacturer's MDD certificate is expired, according to the Article 120 Transitional provisions, no matter that the manufacturer's MDD certificate is expired, you can sell MDD products until the expiry date on the device.

You cannot purchase this product more from the manufacturer if it has not received an MDR certificate.

General safety and performance requirements – Annex 1- is applicable for MDR medical devices. All MDR medical devices must be in compliance with applicable requirements from section 23 of Annex 1.

For more information, see:

• EU MDR Article 120 Transitional provisions https://advisera.com/13485academy/mdr/transitional-provisions/
• EU MDR Annex 1 – General safety and performance requirements https://advisera.com/13485academy/mdr/general-requirements/