M
MCaler
Do IVDs also have to be registered in the Medical Device Databank, or is there a different/separate databank?
M
medic61
I contacted our Eu rep and they told me they could not help us as they don't have anyone who is Italian. Our EU rep "filed an official complaint with the EU Commission as this procedure is clearly against the idea of free trade in the EU. Their complaint was accepted and the Commission is already in receipt of a reply from the Italian authority. We are now waiting for further instructions."
We have a great EU rep who is not afraid to speak out for our rights!! If they advise me of the results of the complaint I will post it here.
Bree
We have a great EU rep who is not afraid to speak out for our rights!! If they advise me of the results of the complaint I will post it here.
Bree
Q
Quality Up North - 2010
Hi All,
Not sure if this has been answered already, but I'm being told by our Italian rep that I HAVE to provide my date of birth and now a copy of either my passport or identification to show that I'm who I say I am, as a representative of our company. First off, I'm no spring chicken so my birth date is the business of only those who need to know
, but a photocopy of my identification? In this day and age of identity theft, I don't think so! And on top of that, what if I leave the company tomorrow? The company will still be running and will still be wanting to do business in Italy, but I won't be part of it and will have no control what so ever in it's business, so why would I want to be forever linked to the company? We have an EU Rep, we are ISO, etc., etc. - why do they need personal information about me??
Not sure if this has been answered already, but I'm being told by our Italian rep that I HAVE to provide my date of birth and now a copy of either my passport or identification to show that I'm who I say I am, as a representative of our company. First off, I'm no spring chicken so my birth date is the business of only those who need to know
, but a photocopy of my identification? In this day and age of identity theft, I don't think so! And on top of that, what if I leave the company tomorrow? The company will still be running and will still be wanting to do business in Italy, but I won't be part of it and will have no control what so ever in it's business, so why would I want to be forever linked to the company? We have an EU Rep, we are ISO, etc., etc. - why do they need personal information about me??
M
MIREGMGR
Perhaps it would be amusing to ask them to provide you with appropriate proof that their handling of the requested information would be verifiably consistent with EU personal data privacy regulations.
Somehow I doubt if they have such compliance.
Somehow I doubt if they have such compliance.
Q
Quality Up North - 2010
I'm not sure they could prove compliance to that - I'll check into it and thanks for your response!
R
Roland Cooke
From a recent Clinica, go to the source for more info:
By Bernard Murphy
Published Online: 05/05/2009
Italy has postponed, for a second time, the implementation of requirements related to the registration and coding of all medical devices in the Repertorio catalogue. The April 30 2009 deadline – itself the result of a postponement in December 2008 – has now been extended to December 31 2009.
The postponement, needed to finalise the system, enables all devices (covered by the 93/42 medical device directive) to still be sold, used or dispensed, in the context of the national health service (SSN), despite not having the code required by article 5 of the ministerial decree of February 20 2007.
Medical technology industry association Assobiomedica welcomed the move. "This is good news for the industry, in that it provides a chance to resolve ongoing problems – both technical and in terms of simplification – with the Repertorio," corporate relations director Fernanda Gellona told Clinica.
"The postponement will also be very useful to the ASLs [local healthcare providers], in terms of having more time to get used to the system," she added.
European industry federation Eucomed also said it welcomed the Italian health ministry's decision, "as this will allow more time to further modify the Repertorio, as outlined in the Italian government's response to the European Commission".
The Repertorio will definitely be up and running by the new end-2009 deadline, Assobiomedica believes. "The main bulk of the work has already been completed," said Dr Gellona, who was keen to underline the strength of Assobiomedica's ongoing collaboration with the medical devices directorate.
By Bernard Murphy
Published Online: 05/05/2009
Italy has postponed, for a second time, the implementation of requirements related to the registration and coding of all medical devices in the Repertorio catalogue. The April 30 2009 deadline – itself the result of a postponement in December 2008 – has now been extended to December 31 2009.
The postponement, needed to finalise the system, enables all devices (covered by the 93/42 medical device directive) to still be sold, used or dispensed, in the context of the national health service (SSN), despite not having the code required by article 5 of the ministerial decree of February 20 2007.
Medical technology industry association Assobiomedica welcomed the move. "This is good news for the industry, in that it provides a chance to resolve ongoing problems – both technical and in terms of simplification – with the Repertorio," corporate relations director Fernanda Gellona told Clinica.
"The postponement will also be very useful to the ASLs [local healthcare providers], in terms of having more time to get used to the system," she added.
European industry federation Eucomed also said it welcomed the Italian health ministry's decision, "as this will allow more time to further modify the Repertorio, as outlined in the Italian government's response to the European Commission".
The Repertorio will definitely be up and running by the new end-2009 deadline, Assobiomedica believes. "The main bulk of the work has already been completed," said Dr Gellona, who was keen to underline the strength of Assobiomedica's ongoing collaboration with the medical devices directorate.
M
MIREGMGR
Do you mean www.clinica.co.uk? I can't find such an article there on or near 05MAY2009. Do you have a specific article link?
R
Roland Cooke
Apparently not. 
I just checked the website and I can't see it there either, even as a "locked" page.
It may have come via their news subscription service, so an update to the main site may come later.
I just checked the website and I can't see it there either, even as a "locked" page.
It may have come via their news subscription service, so an update to the main site may come later.
M
MIREGMGR
This particular problem has been very stubborn, but perhaps it's getting closer to becoming diminished for some of us.
Following is a quote from an email notice sent by our EC Authorized Representative. I've masked their identity to avoid commercial-identification concerns and also because I believe they think they're on iffy legal ground telling their customers this info:
The same notification was sent to multiple customers, and we do not actually have a registration process under way thus the last paragraph is somewhat confusing. Nonetheless this is very good news for us since even with a liberal use of group definitions we probably would have hundreds of separate €100 registration fees to be paid given our rather broad product range, thus amounting to a sizeable cost that would not be easy to recover. All of those products are MDD Class I or I-s, thus (we hope) falling into the supposedly-prospective exception.
Separately, we have not heard further word regarding the legal action that supposedly was proceeding in Brussels, i.e. the EC suing the Italian authorities for imposition of a regulatory scheme that conflicted with their obligation to respect the EC-wide nature and primacy of EC medical device regulations. Has anyone got further info on that?
Following is a quote from an email notice sent by our EC Authorized Representative. I've masked their identity to avoid commercial-identification concerns and also because I believe they think they're on iffy legal ground telling their customers this info:
The same notification was sent to multiple customers, and we do not actually have a registration process under way thus the last paragraph is somewhat confusing. Nonetheless this is very good news for us since even with a liberal use of group definitions we probably would have hundreds of separate €100 registration fees to be paid given our rather broad product range, thus amounting to a sizeable cost that would not be easy to recover. All of those products are MDD Class I or I-s, thus (we hope) falling into the supposedly-prospective exception.
Separately, we have not heard further word regarding the legal action that supposedly was proceeding in Brussels, i.e. the EC suing the Italian authorities for imposition of a regulatory scheme that conflicted with their obligation to respect the EC-wide nature and primacy of EC medical device regulations. Has anyone got further info on that?
L
Laughing Pierre
01 Jan 2010 has been and gone. Does anybody know the current situation regarding medical device registration in Italy?
I read that the EU has brought an infringement action against the Italian government, but I cannot find any information about it on the EU website. Does anybody out there have any further information or a link to the EU website that would have more?
I read that the EU has brought an infringement action against the Italian government, but I cannot find any information about it on the EU website. Does anybody out there have any further information or a link to the EU website that would have more?
