National Requirements for Resale of Medical Devices in EU

E

Erik Vollebregt

#1
Hi everyone, I'm researching whether there are national requirements for the resale of medical devices in the EU after they have been placed on the market / put into service legitimately and are subsequently sold after use by the first end user. If I look at the three EU directives for medical devices this should be allowed as long as the device concerned stays within the CE marked parameters.

I understand that France has requirements for devices that need maintenance: the seller has to provide a certificate that the device has been maintained correctly. In the Netherlands, Germany and Italy there are no such rules as far as I can determine.

Does anyone know of such national requirements in other countries?

Many thanks for your help.
 
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J

jaskosk

#3
When you notify the medical devices in the EU (and affix the CE marking), you should in theory be allowed to sell in the whole EU. However, certain countries came up with additional requirements, and request a national registration as well.

The medical device directive is from a legislative point of view not a directly transposable law, meaning that all the EU member states are allowed to add requirements to the law but they cannot remove elements from the law. The below mentioned countries have decided to add national device registrations on top of the current requirements



For the national registration:

The categories of medical devices covered by French additional requirements are:

? MDD Class IIa devices

? MDD Class IIb devices

? MDD Class III devices

? Active implantable medical devices (AIMDD)


The categories of medical devices covered by Greek additional requirements are:

? MDD Class I, Is, Im devices

? MDD Class IIa, IIb, III devices

? Medical custom made devices

? Kits & Procedure Packs

The categories of medical devices covered by Italian additional requirements are:

Any medical devices under any of the medical device directives (MDD, AIMDD or IVDD) that is to be sold in Italy must be registered in the Italian NSIS Database.

Registration is no longer required for MDD Class I devices that have European Authorized Representation located outside of Italy. Thus, Class I devices represented by CE.way do not have to be registered in NSIS.

The categories of medical devices covered by Latvian additional requirements are:

? MDD Class IIb devices

? MDD Class III devices

? Active implantable medical devices (AIMDD)

The categories of medical devices covered by Portuguese additional requirements are:

? MDD Class IIa devices

? MDD Class IIb devices

? MDD Class III devices

? Active implantable medical devices (AIMDD)
 
E

Erik Vollebregt

#4
Thanks all for the suggestions, but I am investigating if there are specific national rules in the EU that regulate / impact on the resale of devices that have already been placed on the market the EU in accordance with all the applicable rules. So basically rules for selling devices that have been placed on the market correctly in the 2nd hand market. The only one I could find so far is the French rule about certifying correct maintenance that I mentioned in my question.

Yes, I am a lawyer (not a student) but also lawyers sometimes wonder about rules too.

Best regards,
Erik
 
Last edited by a moderator:
G

Gert Sorensen

#5
Hi Erik,

In this regard, are you also interested in the issue of refurbished devices, or is it purely the sale of second hand devices?
 
E

Erik Vollebregt

#6
Hi Gert,

It concerns purely second hand devices. Reasoning from the Medical Devices Directive this should not be a problem as long as performance is within CE marked specs, but after I found this requirement in France I got curious what else there might be.

Best regards,
Erik
 
J

Jerome

#7
Re: National requirements for resale of medical devices in EU?

Hi Erik,
What was the outcome of your research?
I am looking for regulations and/or legislations w.r.t. control or prohibition of reselling medical devices.
This is in a certain way connected to the manufacturers responsibilities during the expected life time of the device and the vigilance processes.

Any info on the subject would be helpfull for me as I'm thinking about putting this in either sales contracts or SLA's of our MD's
 
M

MIREGMGR

#8
Re: National requirements for resale of medical devices in EU?

This subject is of interest to my employer as well. We recently have become aware of a seller on Ebay who specializes in small quantities of non-recent, but within-expiration, single use sterile medical devices. These are sold, and therefore shipped to the buyer, as individual pouches without their secondary packaging. As our sterility-maintenance validation presumes that shipping is always in our engineered secondary packaging, this then is a violation of our regulatory responsibility, even though we have no control over the situation since this seller obtains their goods by some means other than purchase from the manufacturer's distribution channel.

The goods we've investigated so far originally were sold to one of several large New-York-City-area hospitals. The Ebay seller apparently is located in Brooklyn, NY. Our surmise is that the individual product-pouches "walked out the door" in some manner, and the Ebay seller came to possess them at a low cost. That however is just a guess.

So far US FDA has not been helpful to us in controlling this seller, as they have concluded that the seller's activities while highly questionable do not violate the FD&C Act. (But again, we as the manufacturer may have legal problems as a result of those seller-activities.)

I'm very curious as to European laws that might be applicable.
 
E

Erik Vollebregt

#9
Re: National requirements for resale of medical devices in EU?

Hi Jerome, so far I haven't heard about any other national rules than the French one described in this thread. If you want to impose contractual restraints on the first buyer of the device, there are a number of things you can do with warranty, effects on after sales service etc. I'd be happy to help you develop some options.
 

dgrainger

Trusted Information Resource
#10
In the UK the General Product Safety Regulations 2005 SI 2005/1803 (GPSR) implementing the EC Directive on General Product Safety (2001/95/EC) will apply if to "consumers".
 
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