Experience with IMB as Competent Authority of Drug Device Combination Products?

[ohmohm]

Does anyone have experiences using the Irish Medical Board as Competent Authority during evaluation of a Drug Device Combination Product?
I am especially interested in knowing their level of requirements for Clinical Trials.

[Gert Sorensen]

Just bumping this thread. Any takers on this one?

[Roland Cooke]

The Irish Medicines Board made a big play about five years ago, they clearly saw an opportunity to conduct these reviews. Presumably as some combination of a revenue source, supporting the large medical device industry within the the Republic, as well as probably for general altruistic purposes.

Unfortunately for some reason, this project appears to have died a complete death, before getting anywhere which was a shame, since the Scandinavians were swamped, the British were in a state of...er...flux , the rules in Germany were confusing (well, at least to me ), EMEA was still in its infancy with these reviews, and most other countries weren't geared up at all.

I can't tell you the state of play with the Irish at the moment, especially not relating to their CI requirements.

However their website is (at least was!) good, so I would recommend simply getting in contact with them.


Nowadays, SGS tends to use the Dutch and the British medicines agencies, there are pros and cons with both. We wouldn't ever rule out using the Irish, or anyone else for that matter.

[EamonnJohn]

Originally Posted by ohmohm

Does anyone have experiences using the Irish Medical Board as Competent Authority during evaluation of a Drug Device Combination Product?
I am especially interested in knowing their level of requirements for Clinical Trials.

I agree with previous post - best advice is to contact the IMB classification section first to begin discussions.

Also of note is to consider how you are registering the product --will it be as a medical device or as a medicine which is delivered via a Med Device.
if it is the latter then that is a whole different ball game

[WEHTTAM]

Eamon is correct. You have to decide if it is a drug or a device. If a class 3 device then you need to go through a Notified Authority. IMB only deal with Class 1 devices...Hope this helps

[Roland Cooke]

Originally Posted by WEHTTAM

Eamon is correct. You have to decide if it is a drug or a device. If a class 3 device then you need to go through a Notified Authority. IMB only deal with Class 1 devices...Hope this helps

This is [probably] not the full story.

If the product is a device with ancillary pharmacological action (e.g. catheter with a heparin coating), then the device is indeed Class III, and you do need a Notified Body. However the Notified Body must get an opinion from a Medicines Competent Authority, of which the IMB is one, before the device can be certified.

It is the Notified Body' decision which MCA to use, but your opinion as a customer would be taken into account.


The IMB may also need to be involved at an even earlier stage, for example if a clinical trial in Ireland was determined to be required, as was indicated in the original post.