When is "placing on the market"? MDD certified medical devices

Ronen E

Problem Solver
Staff member
Moderator
#21
Actually you can sell till one year after your MDD EC certificate get expired.
As I can see your exp date is 15 Feb 2022; You can sell device till 14 Feb 2023; on 15 Feb 2023 - ① Cleared customs (in EU region) by 15 February 2023
Not true.
 
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Ronen E

Problem Solver
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Moderator
#23
As far as I know, you "can" sell any product anywhere, any time, as long as a customer will pay you for it. There is no law or regulation, including the MDR, that determines what anyone "can" and "cannot" do.
Not accurate.
The EU has an enforcement policy and regulations, captured under the term "Market Surveillance" (annoyingly similar term to "Postmarket Surveillance", but not the same). How well it's budgeted and implemented is a separate matter, but in legality terms, it's there.

Of course, you are "allowed" to break the law anywhere and anytime, you'd "only" have to bear the consequences if you're caught.
 

Watchcat

Trusted Information Resource
#24
I was speaking from the latter perspective, although I would argue further than no one can "allow" you to do something unless they are in a position to stop you. Virtually all enforcement is reactive, action that occurs (and legally, can only occur) once you have taken an action (or sometimes neglected to take an action). You "can" put someone in prison for a crime they didn't commit, but it's pretty hard to put anyone in prison for a crime that has not been committed. Customs is a good example of an exception, as they *can* stop your product from getting to your customer and, in that case, the customer is probably not going to be willing to pay for it.

My problem with the use of "can" and "can't" in these situations is that it is often not only inaccurate and therefore not useful (occasionally harmful), but also often neglects to communicate the information that is accurate and therefore useful.
 

Ronen E

Problem Solver
Staff member
Moderator
#25
My problem with the use of "can" and "can't" in these situations is that it is often not only inaccurate and therefore not useful (occasionally harmful), but also often neglects to communicate the information that is accurate and therefore useful.
I was being brief in my response to @SKM.Sunil because I'm tired of explaining the same thing for the 100th time. I simply wanted there to be a warning for anyone coming across that post. And now there is.

I wasn't trying to be useful and I'm sure I wasn't being harmful.

Ronen out.
 

SKM.Sunil

Involved In Discussions
#27
I was just interpreting these 2 lines from article 120 (MDR), hence I said after expired certificate, the device can be put on service/sell till one year.

Article 120:
Certificates issued by notified bodies in accordance with Directives 90/385/EEC and 93/42/EEC from 25 May 2017 shall remain valid until the end of the period indicated on the certificate, which shall not exceed five years from its issuance. They shall however become void at the latest on 27 May 2024.

Devices lawfully placed on the market pursuant to Directives 90/385/EEC and 93/42/EEC prior to 26 May 2020, and devices placed on the market from 26 May 2020 by virtue of a certificate as referred to in paragraph 2 of this Article, may continue to be made available on the market or put into service until 27 May 2025.
 

Ronen E

Problem Solver
Staff member
Moderator
#28
Article 120:
Certificates issued by notified bodies in accordance with Directives 90/385/EEC and 93/42/EEC from 25 May 2017 shall remain valid until the end of the period indicated on the certificate, which shall not exceed five years from its issuance. They shall however become void at the latest on 27 May 2024.
The highlighted sentence just means that even if a certificate states an expiry date after 27 May 2024, it will nevertheless expire on 27 May 2024.
Devices lawfully placed on the market pursuant to Directives 90/385/EEC and 93/42/EEC prior to 26 May 2020, and devices placed on the market from 26 May 2020 by virtue of a certificate as referred to in paragraph 2 of this Article, may continue to be made available on the market or put into service until 27 May 2025.
That's why it's important to distinguish "Placing on the Market" from "Making Available on the Market" (both are officially defined EU terms), and from "sell" which can mean many different things unless a clear definition is attached. The original discussion was related to Placing on the Market, and I was commenting from that perspective. Placing on the Market does not occur at first entry to the EU (e.g. customs). I will stop here because I'm already repeating myself, which is exactly what I wanted to avoid.
 
Last edited:

myusoffice

First Time Right...
#29
Hi, although the question is related to MDD, i thought it wouldn't harm pulling a reference from MDR.
According to MDR Article 2 definition 28, IVDR Article 2 definition 21,
‘Placing on the market’ means the first making available of a device, other than an investigational device, on the EU market.
Then...
According to MDR Article 2(27).
‘Making available on the market’ means any supply of a device, other than an investigational device, for distribution, consumption or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge.

So, to answer your question, whether it is cleared from custom or stored in distributor warehouse, as long as it enters in European Market in course of a commercial activity (Free of charge or in return of payment), it is considered placing on the market. Only exception is device for investigation purpose.

Hope this helps.
 

Ronen E

Problem Solver
Staff member
Moderator
#30
as long as it enters in European Market in course of a commercial activity (Free of charge or in return of payment), it is considered placing on the market.
The question remains, what does "enters in European Market" mean exactly. I answered this question more than once (hint: it's not intuitive), won't go there again.
 
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