Italy is the fifth largest device trial market in Europe, strong in cardiovascular and orthopaedics. We file to the Ministry of Health, not AIFA, secure a binding nationwide CET or CEN ethics opinion and open IRCCS and SSN sites, all under EU MDR 2017/745 and Legislative Decree 137/2022.
Platinum Award 2026
Top prize in the xShare x European CRO Federation "EHDS & Clinical Research" Open Call, awarded to Eclevar MedTech and its Milo Health platform, presented at the EUCROF 2026 conference in Amsterdam.
Horizon Europe · Grant Agreement No. 101136734 · Amsterdam, 2 Feb 2026
Device leaders rely on Eclevar to run EU MDR trials in Italy and across Europe. Read all client success stories.
Dr Mark DaCosta, COO and former TÜV SÜD reviewer, leads a team that builds Italian dossiers to the MDCG templates and technical specifications the Ministry of Health expects, then runs the study to EN ISO 14155:2026 with Italian-speaking CRAs near the sites. The same evidence base feeds your clinical evaluation and CE mark under EU MDR 2017/745, not a file coordinated blind from elsewhere.
Italian evaluation windows depend on device class, and insurance is mandatory and scales with risk. We build the feasibility and site selection plan around them.
Italian research runs through the Servizio Sanitario Nazionale and IRCCS facilities, with leading investigators in university hospitals. We turn that into a Clinical Evaluation Report and PMCF plan that support your CE mark.
Ablation catheters, structural heart implants, orthopaedic devices and software as a medical device diverge in endpoints, investigator profiles and assessor expectations. Our depth is in cardiovascular clinical strategy, where 81 of the roughly 239 Italian device studies in a three-year window sit, ahead of oncology and orthopaedics.
Confirm device class, authorisation route and MDCG dossier scope.
File to the Ministry of Health and secure the CET or CEN opinion.
Build the CER and PMCF programme to EU MDR and EN ISO 14155.
Open IRCCS and SSN sites with Italian-speaking in-house CRAs.
PMCF, vigilance and Codice Privacy governance kept current.
No. For medical devices the competent authority is the Ministry of Health, the Ministero della Salute, under Legislative Decree 137/2022. AIFA is the medicines agency and does not authorise device investigations. This is a common and costly point of confusion.
A Territorial Ethics Committee (CET) or, for certain studies, the National Ethics Committee (CEN). The favourable opinion is valid across the whole country and binding for every participating centre, so one opinion covers a multi-centre study.
For a Class III or implantable device, the Ministry technical-scientific evaluation runs 45 days from validation, extendable by 20. For a Class I or non-invasive Class IIa or IIb device, the investigation can start 30 days after validation. Ethics windows are 30 or 45 days by class.
A single national fee applies, set by the 2023 decree covering clinical trials and the ethics committee coordination. Italian site costs are competitive, below the UK and Germany.
A CE marked device used within its intended purpose follows a lighter communication to the Ministry under Article 16(3) of D.Lgs. 137/2022 and Article 74 of the MDR, rather than a full authorisation.
Talk to our team about your device class, the Ministry of Health route and how to open IRCCS and SSN sites under EU MDR and D.Lgs. 137/2022.
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