Clinical Trials in Europe - What is the "competent authority" in Italy?

[45fan]

Greetings from a new user. This is my first post. I've been reading and using info from this site for a while. Truly a blessing to the industry. I must thank Marc for starting and maintaining this site and all of the participants for the helpful and sometimes entertaining posts.

I am currently setting up a quality system for a new medical device firm and planning clinical trials in Europe, Italy to be exact. The quality system is about 25% and I've been asked how soon we can do some clinicals.

I have a few questions for starters.

1. Is anyone aware what is the "competent authority" in Italy?

2. The MDD does not explicitly require quality systems compliance for clinical investigations, but does imply such in Annex VIII, along with requiring consent to assessment, or audit where necessary, that manufacturing processes and controls produce product to spec. Sounds like a QS to me. Am I reading this right, or too much? Or do I need to consult the Italian authorities and the hospital before I determine how complete my QS needs to be?

Best regards,
Tom

[Vincnet]

45fan said:

I have a few questions for starters.

1. Is anyone aware what is the "competent authority" in Italy?

2. The MDD does not explicitly require quality systems compliance for clinical investigations, but does imply such in Annex VIII, along with requiring consent to assessment, or audit where necessary, that manufacturing processes and controls produce product to spec. Sounds like a QS to me. Am I reading this right, or too much? Or do I need to consult the Italian authorities and the hospital before I determine how complete my QS needs to be?

Best regards,
Tom

Hi Tom
From your reference to annex VIII I assume you are takling of an IVD MD. In this case the requirements for your QS are directly linked to the classification of your IVD Annex II or not.
I can't give you the CA for Italy (I think it is the Ministery of health but not sure) but you will find here the list of Notified Bodies

*** Dead Link Removed ***

and here is a link to the Italian Association of MD Manufacturers
Assobiomedica

My understanding of the 98/79/EC is that you need for your Product Evaluation the same QS as for the final product.

Expect this helps

V

[45fan]

Thank you Vincnet for your reply, particularly the links. I just browsed them quickly, but the look very helpful.

Actually, I do not have an IVD, but a surgical assist device that falls under the Medical Device Directive (the MDD) that is 93/42/EEC. Annex VIII is the "statement concerning devices for special purposes".

I did discover that the CA is the Ministry of Health, but all of their literature and forms are in Italian. Since we have an Italian employee on board, this won't be such a problem. I also discovered that it is best to let the doctors contact the Ministry of Health since they are familiar with the process already.

Regards,
Tom

[RosieA]

45fan,
I've been out of medical devices for a couple years, but my notified body informed me that in order to do clinical trials in the EU, the product had to be CE marked. I always thought that was wierd because it's a cart before the horse situation, so we always did our clinical trials in the US, or in the animal research market. Check with your notified body, they're usually the best resource.

[Vincnet]

RosieA,
I can't remember exactly for MDs but for IVDs if you want to run a clinical trial in order to get a CE mark, your IVD has the status of Device for Performance Evaluation.
This basically means that the Device is allready manufactured under the correct GMP (depending on the IVD's category) and fullfills the Essential Requirments. You just have to send a statement to your CA where you tell them what the device is and what the study plan is with number of sites, number of subjects, expected starting date and expected duration.
And your devices need a special Labelling stating "PED" with a nice Logo.
I might have to work on the MD Directive soon, so I am going to check what they say.

Hope this helps

V