MDD certificate expiration

[aravindh]

Hi,

Does the MDD certificate expire for a product if I get a MDR certificate for the same product?

Example:

I obtained MDR for device A on 21 Mar 2020. For the same product expiry date on the MDD certificate is mentioned as 23 April 2024.

Until 23 April 2024, does Device A have valid MDD and MDR certificate?

 

[Billy Milly]

This is technically possible, if you did not make singnificant changes on the device and you did not withdraw the product from the "MDD certification list". I doubt that this is the case since you would then be stuck with multiple surveillance audits, etc. I do not see any benefit in this scenario.
Is the NB the same in both cases?

 

[aravindh]

Thanks Billy for the response. Yes, MDD and MDR certificates were issued by same NB..

Until the MDD certificate expires, we would like to continue manufacturing MDD compliant devices.

 

[Orca1]

Hi,

Does the MDD certificate expire for a product if I get a MDR certificate for the same product?

Example:

I obtained MDR for device A on 21 Mar 2020. For the same product expiry date on the MDD certificate is mentioned as 23 April 2024.

Until 23 April 2024, does Device A have valid MDD and MDR certificate?

The MDD certificate for a product does not automatically expire if you obtain an MDR certificate for the same product. MDD certificates can remain valid until their expiration date or until 27 May 2024 at the latest, as long as the conditions laid down in Article 120(3) of the MDR are complied with (MDCG 2019-6 Rev.3, Page 10, Paragraph 1). However, it is important to note that no issuing of new MDD/AIMDD certificates, including modified, amended, or supplemented certificates, is allowed under MDR Article 120(3) (MDCG 2020-3, Page 3, Paragraph 2).

 

[KhPat]

If the MDD certificate is expiring and manufacturer are not intending to move forward with MDR, what is the correct method to inform EU Distributors regarding this, is there a guidance document for this?