Veterinary Medical Device Registration in the EU and Italy

M

MD_Simy86

#1
Dear all,
I'm looking for a specific information regarding veterinary medical medices::confused:

is there a regulation or guideline concerning veterinary medical devices in UE?
Is it compulsory for them to be registered in the Italian databank in order to commercialize in Italy?

Thank you so much in advance for the availability and help,
see you! :bigwave:
 
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pkost

Trusted Information Resource
#2
Re: Veterinary medical device registration

I'm not in the veterinary field but have had general conversations in the past about selling an MD into this field. I was under the impresssion that there isn't any EU legislation, however there may be legislation at a national level (I don't know for italy)
 
A

april89

#3
I don't know if this is of any help but I believe that most electrical veterinary medical devices will fall under the IEC 60601 standard. My reasoning for this is because:

The 60601-1-1 3rd edition scope applies to "the BASIC SADETY and ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT (ME EQUIPMENT) and MEDICAL ELECTRICAL SYSTEMS (ME SYSTEMS).

The 60601-1 ME EQUIPMENT definition refers to a PATIENT where a PATIENT is defined as a "living being (person or animal) undergoing a medical, surgical or dental procedure".

I don't believe there are any references to veterinary applications in the MDD though so compliance is probably not a requirement, just good practice, but you would need to check this. :)
 
S

SteveK

#4
I did a Google translation from the Italian SALUTE regulatory site which gives the following:

Requirements for production and marketing in Italy

At the moment there is no Community or national regulations for the production, marketing and use of medical devices, veterinary, except microchip identification of dogs.
In fact, unlike what happens in the human, for this type of product there are no specific technical harmonization directives, which establish the essential minimum requirements at EU level.
The veterinary medical devices are, however, regulated by the general legislation on the safety of products marketed in the EU.
In addition, for certain types of medical devices, veterinary, arriving from other countries, the import is conditional, subject to normal customs checks carried out on all imported goods, even to the health inspection carried out by the Veterinary Services of the Border Inspection Posts (BIP).
General Provisions
Subject to the Ordinance of the Ministry of Labour, Health and Social Policies, August 6, 2008, according to which the microchip identification of dogs can be produced and marketed only by persons registered with the Ministry of Health, at present those who intend to import, manufacture or market this type of product in Italy has no obligation of prior notification or communication Competent Authority in the matter.
Moreover, in the absence of Community directives on technical harmonization concerning veterinary medical devices, it is not expected to be the last for the affixing of the EEC approval mark (which as such has no reason to be alone for medical devices used in human medicine and for other products that in the EU are regulated by specific directives on technical harmonization in the sector).
Nevertheless, even the veterinary medical devices, like any other product, which must be entered in the EU, in order to be freely marketed must comply with the minimum safety requirements. These requirements are set out in EC Directive 2001/95 on general product safety, implemented in Italy by Legislative Decree 172 of 21/04/2004. This implies an obligation on the part of manufacturers to comply with all applicable national or Community rules (mandatory or not) for the production of such products and the European Commission recommendations setting guidelines on product safety assessment.
The Directive 2008/13/EC repealed Directive 84/539/CE concerning equipment used in veterinary medicine, which was the only existing provision of Community law in the field of veterinary medical devices.
The repeal of Directive 84/539/EEC requires that after December 31, 2008 the mark of conformity referred to in Annex III to that Directive will no longer be used and that the corresponding national implementing measures be repealed accordingly.
Electrical equipment used in veterinary medicine must comply with the requirements of Community law which regulates the general machinery sector represented by the Directive 2006/42/EC on machinery, Directive 2004/108/EC on electromagnetic compatibility and Directive 85/374 / EEC concerning liability for defective products.
Special provisions relating to products for in vitro diagnostics, laboratory reagents ready to use and intermediate products of animal origin derived from Category 3 material imported from Third Countries
The products for in vitro diagnostics and laboratory reagents for veterinary use ready to use imported from third countries (except for exchanges between universities) must be accompanied by a veterinary certificate issued by the Competent Authority of the country of origin certifying that the third "The product is manufactured under hygienic conditions, it carries pathogens and is not dangerous."
The health checks at the BIP is also mandatory for the import and transit of intermediate products derived from Category 3 material intended for technical uses in the manufacture of medical devices, in vitro diagnostics and laboratory reagents ( EC Regulation . 2007/2006 of the Commission of 22 December 2006 ). This type of products must be accompanied by a commercial document and a declaration by the importer conforms to the model set out in Annex II to Regulation (EC) No. 2007/2006.
To import one of the types of products described above must give notification to the BIP of entry with at least one working day in advance, using the appropriate form, of each batch of incoming goods (accompanied by relevant health certificate).

Steve
 
M

MDDRegAffairs

#5
Dear Steve K,

Thank you for the detailed post. I am just starting my path in regulatory affairs and am working on a project to affix a CE mark to a device for veterinary use. If the device is in comlpiace with Directive's 2001/95/EC, 2006/42/EC, 2004/108/EC, and 2004/108/EC, what would be the next step to affix the CE mark?

Any comments would be greatly appreciated,

Regards,

Tom
 

pkost

Trusted Information Resource
#6
Hi,

You list two directives that use CE marking: EMC and machinary. I do not know these specifically, however the general principle of applying a CE mark is:

1. Verify directive is applicable
2. follow the select an appropraite conformity assessment which will include amongst other things
a) demonstrating compliance with essential requirements
b) generating a technical file
c) appointing a notified body to review technical file (in some cases)
d) signing a declaration of conformity


to be clear (as you are posting in the medical device section)...a veterinary product is not a medical device and therefore cannot carry a medical device CE (unless primarily intended for use in humans)

you may get a better response on how to apply a CE mark for EMC and machinary by starting a new thread, this one is a little obscure for EMC and machinary guys!
 
M

MDDRegAffairs

#7
Hello pkost,

Thank you kindly for the comments and suggestions. Your response is helpful and greatly appreciated.

Regards
 
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