MDR legal actions - manufacturers

marie luis murray

Starting to get Involved
#1
Dear readers,
someone expert in MDR and EU regulation could help on this question?

We know that the MDR has increased the requirements in terms of safety and performance that a manufacturer should comply with. However, does someone know if the MDR contempaltes legal action agains manufacturers of medical devices not correctly placed on the market?

In other words, If a non-medical device product is put on the market and sold in the EU with a borderline intended use/claims, what happens if someone or a Notifeid Body or Agency regatory detects that it should be classified as a medical device? do these regulatory authorities have the capacity to take legal actions agains this manufactuerr? do they require te manufacturer to withdraw the product from the market?

I think that in the US there is some type of notification that is send to the manufacturer to withdraw the producr or registered as a medical device, but not 100% sure...

thanks a lot!
MLM
 
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CharlieUK

Quite Involved in Discussions
#2
Notified Bodies have no enforcement ability

As a manufacturer you should review the scope of the Medical Directives/Regulations and if you are satisfied that you are outside the scope you should document your rationale for the Directives that you have applied and demonstrated compliance against

It would then be up to a regulator to challenge that assertion
The EU has procedures for notifying member states where products need to be withdrawn from the market
 

Ed Panek

QA RA Small Med Dev Company
Staff member
Super Moderator
#3
MDR has increased requirements for distributors and importers along these lines to assure the devices are properly labelled and marketed per MDR. I dont think there would be a legal issue but a quality partner is important now in EU.
 

marie luis murray

Starting to get Involved
#4
Hello CharlieUK and Ed Panek,

thank you very much for your answers!!

according to CharlieUk answer, it is my understaning that the EU has procedures and can notify a MS if they "detect" a product that should be categorised as a MD and which is currently comercialised as a "general product" (not a Medical Device). Is this correct?

It is my assumption, that in this scenario, the manufacturer should withdrawn the product from the market or registered as a medical device. Is this correct?

Thanks again for your answers,
Best
MLM
 

CharlieUK

Quite Involved in Discussions
#5
Enforcement action would be taken against a product that didn't comply with the applicable Directives - this could take various forms and withdrawl is likely to be required
 

Sinus Tarsi

Starting to get Involved
#6
Looking for some updated guidance on this topic. MDR became effective last week. Our company has a valid MDD cert until 2023. Our devices are class IIa and Class IIb. I know we can still market to the EU - my question is, can we ship directly as we have done in the past or must we now use an Importer/Economic Operator? Are there any specific requirements of MDR that we must follow before becoming MDR compliant?
 

Ed Panek

QA RA Small Med Dev Company
Staff member
Super Moderator
#7
Same situation I am in. There are sections of MDR you are required to complete regarding post-market surveillance vigilance etc. For Eudamed we are trying to obtain our EORI right now so once Eudamed becomes in effect we can obtain our SRN.


In practice, the Eudamed is not operational as of yet.

Article 120 <Snip>
3. By way of derogation from Article 5 of this Regulation, a device with a certificate that was issued in accordance with Directive 90/385/EEC or Directive 93/42/EEC and which is valid by virtue of paragraph 2 of this Article may only be placed on the market or put into service provided that from the date of application of this Regulation it continues to comply with either of those Directives, and provided there are no significant changes in the design and intended purpose. However, the requirements of this Regulation relating to post-market surveillance, market surveillance, vigilance, registration of economic operators and of devices shall apply in place of the corresponding requirements in those Directives. Without prejudice to Chapter IV and paragraph 1 of this Article, the notified body that issued the certificate referred to in the first subparagraph shall continue to be responsible for the appropriate surveillance in respect of all of the applicable requirements relating to the devices it has certified.

Until Eudamed is fully functional, the corresponding provisions of Directives 90/385/EEC and 93/42/EEC shall continue to apply for the purpose of meeting the obligations laid down in the provisions listed in the first paragraph of this point regarding exchange of information including, and in particular, information regarding vigilance reporting, clinical investigations, registration of devices and economic operators, and certificate notifications.

Also look at Article 34 of MDR.


its all rather confusing
 

Sinus Tarsi

Starting to get Involved
#8
YES!! Thank you, I read through it and interpreted as - until EUDAMED is fully functional, we do not need to use an Economic Operator / Importer to ship to the EU but can continue as before.

The MDR requirements associated with placing medical devices on the market with an MDD compliant device include: 1) a valid MDD certificate, 2) Continuous compliance of the device with the Directives, 3) No significant changes in the design and intended purpose, 4) Registration of economic operators and of devices, Post market surveillance, Vigilance ... but are not required UNTIL EUDAMED is up and running.
 
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