EU conformity assessment - Certify to MDD or MDR?

bookish

Involved In Discussions
#1
Hello,
I am new to CE marking. If a company would like to do an EU conformity assessment next year, should they choose the MDD or MDR route? It will be close to the end of the transition period. I read that there could be extension granted until May 2024 depending on the product. Would love to hear some suggestions. Thanks.
 

Thulasidharan

Starting to get Involved
#2
Hello,
I am new to CE marking. If a company would like to do an EU conformity assessment next year, should they choose the MDD or MDR route? It will be close to the end of the transition period. I read that there could be extension granted until May 2024 depending on the product. Would love to hear some suggestions. Thanks.
Hi,
Till May 2020 CE marking able to go ahead with MDD. Once MDR come in to force which means after May 2020 your CE certification validity will be decreased to 4 years. In between this 4 years you have to comply with MDR to sustain your products in EU.
 

moounir

Involved In Discussions
#3
Hi Bookish,

As Thulasidharan said, you have the choice until May 2020 but this depends also on the Notified Body.
The number of Notified Bodies will decrease so fist come first served. Check first if the Notified Body you will choose accept to certify you under MDD and also if he will remain a Notified Body with MDR.

There are some exceptions highlighted on the article for Class I, Ir and Implantable class III. So you need to assess that knowing your products classes and characteristic.

And if your products are placed on the market, you can extend until May 2025. Definition of this also on the article.

I hope this helps to get a better picture.
 
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Marcelo Antunes

Addicted to standards
Staff member
Admin
#4
This is a very complex question because it depends on a lot of things. You should probably read the MDR Articles 120 and 123, and also the CAMD Transition Sub Group FAQ.

One thing to consider is the time it will take to get the CE Mark per the MDD, because off you take too long, you won't be able to get a certificate per the MDD (for example, the Brazilian branch of NBs are estimating some 18 months for "approval", so if you begin today in Brazil, you will probably not be able to be certified under the MDD.

Also, several NBs noted that they will stop offering mDD certification long before June 2020.

Finally, even if you get the CE Mark under the MDD, there's provisional requirements that must be met (for example, no significant changes to the device and also the PMS chapter of the MDR will need to be complied with in June 2020).
 

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