Annex XVI Device Transition Timeline under the MDR

[kavinda]

Hello, I'm hoping to gain some clarity on the transition timeline for Annex XVI devices under the MDR. We're a US based company currently selling an aesthetic product in the EU, not subject to the MDD. Under the MDR, this would be considered a Annex XVI device, Class IIa. We currently have no MDD certificate or NB. We seem to be receiving conflicting reports regarding our timeline transition to the MDR. We've been told that without a NB issued CE certificate to the MDR, we will not be able to sell our devices in Europe after May 25th, 2020. However, Article 1(2) of the MDR states that the MDR will only apply to Annex XVI devices after Common Specifications are released, which come into force 6 months later. To our knowledge, no CS's are currently available. So, our ultimate question is: are we able to keep selling our device after May 26th, 2020, or do we need to halt EU sales? Thanks!

 

[Ronen E]

From Article 1(2):

The necessary common specifications shall be adopted by 26 May 2020. They shall apply as from six months after the date of their entry into force or from 26 May 2020, whichever is the latest.

Notwithstanding Article 122, Member States' measures regarding the qualification of the products covered by Annex XVI as medical devices pursuant to Directive 93/42/EEC shall remain valid until the date of application, as referred to in the first subparagraph, of the relevant common specifications for that group of products.

According to the Implementation Rolling Plan (updated Dec 20 2019), the implementing act for the common specifications for products without a medical purpose (Article 1(2)) is undergoing the formal adoption procedure and final adoption is expected in Q2 2020. This means that they will definitely begin to apply some time after May 26 2020. When exactly?... I think no one knows now. What the above quote also says is that until that (unknown) date, definitely after May 26 2020, if your Annex XVI device falls within the scope of the MDD you must comply with the MDD - but you say yours doesn't.

A$55

 

[kavinda]

Hi Ronen, thank you for the link, that's helpful! My interpretation is that we are able to continue selling beyond May 25th, (as we are outside the scope of the MDD) but will likely be under the MDR before the end of the year (6 months from Q2). Thanks again.