Until when can we CE-mark and sell MDD class 1 devices?

#1
Our company designs, manufactures and sells class 1 to 3 medical devices (dental implants, abutments and tools to places them).

Under the current MDD our class 1 devices do not require notified body authorisation for CE-marking. That will change on May 26, 2020 when most likely all those class 1 products must be submitted to the notified body in order to be CE-marked under the MDR.

1) Can we continue to produce and sell our MDD CE-marked class 1 products under our current MDD CE-certificate until it expires on 1 April 2023, or can we only sell products manufactured before May 26, 2020, and must we therefore stock up before May 26 2020 to bridge the time until those class 1 products are CE-marked according to the MDR?

2) If we completely finish the development of our new class 1 products, currently still in the R&D-stage, before 26 May 2020, can we still register them according to the MDD, and not needing notified body authorisation?

Thank very much in advance for your help.
 
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Ronen E

Problem Solver
Staff member
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#2
I think that the above contains several misconceptions / misperceptions.

1. You don't have to wait until May 26 to submit your devices for certification under the MDR. In fact, the sooner you submit them the better for you, because by May 26 they already have to be certified - otherwise you won't be able to place them on the EU market.

2. Class I devices that begin coming under require NB certification under the MDR (e.g. reuasable surgical devices) can't benefit the "MDD grandfathering", and must by May 26 be either certified under the MDR or withheld from placement on the market until such certification.

3. Manufacturing or completion of R&D dates are irrelevant. What matters is placement on the market (i.e. first transfer of title within the EU, so import is not included), because devices have to be compliant by at the time they are placed on the market. If you are interested in "stocking up" before May 26, it has to occur "on the other end" of the first transaction inside the EU (e.g. at a cooperating distributor's warehouse).

Class I devices that continue to be exempt from were subject to NB scrutiny under the MDDR may continue to be placed on the market under valid MDD certificates even after May 26.
 
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Asia78

Involved In Discussions
#4
I think that the above contains several misconceptions / misperceptions.

1. You don't have to wait until May 26 to submit your devices for certification under the MDR. In fact, the sooner you submit them the better for you, because by May 26 they already have to be certified - otherwise you won't be able to place them on the EU market.

2. Class I devices that require NB certification under the MDR (e.g. reuasable surgical devices & sterile devices) can't benefit the "MDD grandfathering", and must by May 26 be either certified under the MDR or withheld from placement on the market until such certification.

3. Manufacturing or completion of R&D dates are irrelevant. What matters is placement on the market (i.e. first transfer of title within the EU, so import is not included), because devices have to be compliant by the time they are placed on the market. If you are interested in "stocking up" before May 26, it has to occur "on the other end" of the first transaction inside the EU (e.g. at a cooperating distributor's warehouse).

Class I devices that continue to be exempt from NB scrutiny under the MDR may continue to be placed on the market under valid MDD certificates even after May 26.
No,that is wrong. After may 26 2020, there shall be no more mdd devices class I placed on the market in Europe (if they are not already on the market, e.g in the distribution chain). Rumors are getting stronger that there shall be a delay of the date...
But it is definitely like this, I had a long discussion with our NB on this.
 

Ronen E

Problem Solver
Staff member
Moderator
#5
After may 26 2020, there shall be no more mdd devices class I placed on the market in Europe (if they are not already on the market, e.g in the distribution chain).
Sorry, you are correct, in the sense that class I devices that were exempt from NB scrutiny under the MDD have to migrate to MDR compliance by May 26 in order to be placed on the market after that date (either self- or NB-certified, according to their MDR classification).

The sentence I initially wrote (last one in my previous post) didn't make sense - devices that are exempt from NB scrutiny under the MDD don't have MDD certificates... I was thinking about one thing and writing another... Sorry for that and thanks for picking up. I edited my post above so hopefully it's correct now. I also slightly edited items 2 & 3 in that post, to make them a bit more accurate.
But it is definitely like this, I had a long discussion with our NB on this.
Can you say who your NB is?
 
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#7
No,that is wrong. After may 26 2020, there shall be no more mdd devices class I placed on the market in Europe (if they are not already on the market, e.g in the distribution chain). (...) I had a long discussion with our NB on this.
According to the MDR, Chapter X, Article 120, § 4:
"Devices lawfully placed on the market (…) prior to 26 May 2020 (…) may continue to be made available on the market or put into service until 27 May 2025."

I interpret this as MDD CE-marked class 1 devices may continue to be sold until 27 May 2025. This should also mean that if we can get our class I products currently in development finalised and registered with the competent authorities (and thus CE-marked) before 26 May 2020, we can also continue to sell those devices until 25 May 2025, provided no significant changes are made to them.
 

Ronen E

Problem Solver
Staff member
Moderator
#9
According to the MDR, Chapter X, Article 120, § 4:
"Devices lawfully placed on the market (…) prior to 26 May 2020 (…) may continue to be made available on the market or put into service until 27 May 2025."

I interpret this as MDD CE-marked class 1 devices may continue to be sold until 27 May 2025. This should also mean that if we can get our class I products currently in development finalised and registered with the competent authorities (and thus CE-marked) before 26 May 2020, we can also continue to sell those devices until 25 May 2025, provided no significant changes are made to them.
You are mis-reading this.
That clause talks about units already placed on the market by May 26 2020, i.e. units which have already changed ownership once within the EU. Such units may continue to be on-sold ("made available on the market") until years later. This applies to units, not models.
If your "MDD Class I devices" (units), that are not certified (i.e. non-m/s) are already on the market by May 26 2020 then yes, they may continue to flow in the supply chain and into final use (as well as 2nd hand sales, which are completely outside the scope of the MDD and MDR). However, units of the very same model, not already on the market (i.e. past the first transaction within the EU) by May 26 can't be placed on the market unless they also comply with the MDR, even if there are units from the very same design that are circulating in the supply chain as above.
For this reason, and as I already explained above, R&D finalisation date is less (or not at all) relevant to the issue, except for units of that new design that make it onto the market before May 26.
 

Watchcat

Trusted Information Resource
#10
On a cheery note :sarcasm:, I heard, but cannot confirm, that NB's are telling their clients that their resources for technical file audits are already booked through 2020. If you are not already on their calendar, you are out of luck. That is the NBs that have already been designated, but I think this is likely to includes the resources of the NBs that are waiting for MDR designation, and perhaps even more so.

I don't normally pass along rumors of this nature, but this one seems likely to work with the math. Newly designated NBs all seem to be following the policy of serving existing clients first. Many of their existing clients will, in addition to wanting previously MDD certified devices certified under the MDR, have additional (Class I) devices that need certification. Also, with fewer NBs, existing clients will be hard-pressed to "jump ship" to another NB. So, not much room in the queue for anyone but existing clients, and for NBs that have yet to be designated, existing clients alone probably make up a queue that could easily stretch well into 2021. And get longer every day, as MDD certificates for devices that are transitioning expire every day.

Isn't this ANVISA all over again?
 
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