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Guest user Created:   Sep 30, 2021 Last commented:   Oct 04, 2021

Info packaging

We import medical devices to *** from ***. *** product was CE certified under MDD and can be placed on the market under MDR. The question is how much the product is covered by regulations concerning information provided with the product (section 23 of appendix to MDR)?

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ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

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Kristina Zvonar Brkić Oct 04, 2021

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:

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Sep 30, 2021

Oct 04, 2021

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