Insight · Clinical Operations · Italy
Submitting a device investigation in Italy runs through the Ministry of Health under Legislative Decree 137/2022, with an ethics opinion from a Territorial or National Ethics Committee. One clarification belongs up front, because it trips up many sponsors: for medical devices, the competent authority is the Ministry of Health, not AIFA, which handles medicines.
This page walks through the Italy clinical trial submission route step by step: the Ministry pathway, the CET/CEN ethics opinion, the timelines for Class III and implantable devices, and the documentation rules.
Submitting a device investigation in Italy runs through the Ministry of Health under Legislative Decree 137/2022, with an ethics opinion from a Territorial or National Ethics Committee, and the first thing to get right is which authority does what. One persistent point of confusion is the role of AIFA: for medicines, AIFA is the relevant agency, but for medical devices the competent authority is the Ministry of Health, and a sponsor who plans around the wrong body loses time before the process even begins.
Ministry measures to start an investigation require the unconditional favourable opinion of the Ethics Committee. To save time, a sponsor may submit the application accompanied by a conditional EC opinion, or a copy of the request sent to the EC; in that case the Ministry must receive the positive opinion within the relevant window - 30 days for class I or class IIa/IIb non-invasive devices, 45 days for class IIa/IIb invasive or class III devices, from validation.
The sponsor (or an authorised person) notifies the Ministry of Health in advance of the start of the investigation.
The Italian procedure offers a useful sequencing option that sponsors should understand. Because measures to start an investigation require the favourable opinion of the ethics committee, a sponsor can, in defined circumstances, submit the application accompanied by a conditional ethics opinion to save time, rather than waiting for every step to complete in strict series. Using that option well requires knowing exactly when it applies, which is the kind of procedural detail that local familiarity supplies.
Submissions must use the MDCG templates and meet the technical specifications published on the Ministry of Health website; electronic communications must comply with Italy's Digital Administration Code. Non-EU sponsors must appoint an EU-established representative (Article 62(2) MDR), and statements about the sponsor and its representatives follow Italian self-declaration rules, with certified translations for non-EU parties.
Italy's procedure rewards a complete, correctly assembled dossier from the outset, because gaps trigger queries that the national timeline does not easily absorb. The submission to the competent authority has to be built to the Italian administrative expectations, and a sponsor who assembles it to a generic EU template, rather than the specific Italian requirements, tends to lose time at the first review.
Non-EU sponsors carry an additional, non-negotiable obligation: a sponsor not established in the EU must appoint an EU-established representative under the regulation, and this arrangement has to be in place before the device can proceed. Setting it up early, with the responsibilities clearly defined, avoids it becoming a late obstacle when the rest of the dossier is ready.
The recurring lesson is that Italy is navigable but unforgiving of improvisation. The sponsors who run smooth Italian studies are those who prepare the dossier and the representative arrangement to the country's specific requirements in advance, which is precisely where a team that runs Italian procedures regularly makes the difference.
Italy is unforgiving of an incomplete dossier, because gaps trigger clarification requests that the national timeline does not easily absorb. The submission has to be assembled to the specific Italian administrative expectations, using the expected templates and meeting the technical requirements, and a sponsor who prepares to a generic European pattern rather than the Italian one tends to lose time at the first validation. Completeness at submission is the single biggest lever on the eventual timeline.
The 2023 ministerial decrees also set the requirements for facilities suitable to conduct investigations (Article 62(7) MDR) and the rules ensuring that those assessing and validating applications are independent and free of conflicts of interest. Contracting with compliant sites and anticipating these checks is part of a clean submission.
Timelines reward this preparation too. For Class III and implantable devices the Ministry's technical-scientific evaluation runs to defined windows, and a dossier that is complete and correctly assembled moves through them cleanly, while one that triggers requests for clarification can lose weeks the national procedure does not easily recover.
Non-EU sponsors carry one additional obligation that has to be settled early: a sponsor not established in the EU must appoint an EU-established representative, and that arrangement needs to be in place before the investigation can proceed. Treated as an afterthought, it becomes a late obstacle when the rest of the dossier is ready; handled at the start, with responsibilities clearly defined, it is a simple step. Knowing these specifics in advance is what keeps an Italian submission moving rather than stalling.
Explore how our clinical teams are structured by vertical across multi-country EU MDR studies, including Italy. By verticalEU MDRMulti-country Eclevar runs Italian device-trial submissions through the Ministry of Health under Decreto 137/2022, CET/CEN ethics, MDCG-template dossiers, compliant sites and activation, with
No. For medical devices the competent authority is the Ministry of Health (Ministero della Salute) under Legislative Decree 137/2022. AIFA is the medicines agency and does not authorise device investigations.
A Territorial Ethics Committee (CET) or, depending on the study, the National Ethics Committee (CEN). The opinion is valid nationwide and binding for all centers.
For Class III or implantable devices, the Ministry technical-scientific evaluation runs a standard 45 days from validation, extendable by a further 20 days. Ethics-opinion windows are 30 or 45 days by device class.
Yes. A sponsor not established in the EU must appoint an EU-established representative under Article 62(2) MDR, with additional documentation for non-EU parties.
Planning an Italian device trial? We will run the Ministry of Health route under Decreto 137/2022 and the CET/CEN ethics opinion, and flag the AIFA naming before it confuses a reviewer.
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