Giuseppe Aminzade, head of regulatory life sciences in BonelliErede’s Healthcare & Life Sciences Focus Team, reflects on Italy’s new early feasibility studies guidelines for medical devices.
Over the past few years, Europe’s position in early-stage medical device clinical trials has come under increasing pressure. The regulatory landscape across EU Member States remains fragmented, compliance costs under the EU’s medical device regulation (EU MDR) keep rising, and the lack of a structured pathway comparable to the US Food and Drug Administration’s (FDA) breakthrough device designation programme creates significant hurdles. As a result, first-in-human and early feasibility studies are progressively being conducted elsewhere, not only in the US but also in China, Japan, and South Korea, which are actively developing accelerated regulatory pathways for innovative devices. Italy has now moved to change that, and it is not starting from scratch.
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Back in 2019, the Italian Ministry of Health launched a public call to test whether the EFS model – until then a purely American concept – could work under EU rules. The result was the ARCTRAN study, conducted at the Fondazione Policlinico Universitario Agostino Gemelli IRCCS in Rome: the first EFS ever formally conducted in Italy, and to my knowledge the first in Europe under an MDR-compliant framework. When its results were presented at the Ministry in February 2024, they provided initial proof of concept and set in motion what followed.
In February 2026, the Ministry published its National Guidelines on Early Feasibility Studies (EFS) for Medical Devices, together with an Analytical Code for the Engineering of the EFS Process, a legal and procedural companion document. They establish a new governance model: a clear, efficient, and fully MDR-compliant pathway for international sponsors wishing to conduct early-stage clinical investigations on innovative devices in Italy.
What is an early feasibility study under the Italian framework?
An EFS, under this framework, is a clinical investigation conducted during the early stages of development of an innovative medical device, before the finalisation of its definitive design. The purpose is to evaluate design concepts, functionality, and preliminary safety data under controlled conditions, generating evidence that will guide or halt subsequent development.
This is not a traditional feasibility study or a pivotal trial, where the device design is already locked. An EFS operates in a space of deliberate technological immaturity: the device may evolve in response to what clinicians observe. Sample sizes are small – typically five to 30 subjects – with staged enrolment allowing real-time safety monitoring and iterative refinement.
Full MDR compliance: EFS under Article 62
According to the Guidelines, EFS fall within the scope of Article 62 of the MDR, the provision governing clinical investigations conducted to generate clinical data for regulatory purposes. This is not a workaround. The Guidelines build on the MDCG 2021-6 Rev.1 guidance, which recognises early feasibility investigations – also called proof-of-concept studies – as a subset of pilot-phase investigations that should generally be conducted under Article 62. By anchoring EFS within the existing MDR architecture, Italy offers sponsors greater degree of regulatory predictability for early-stage clinical innovation, an area that has often been challenging across Europe.
As the Analytical Code acknowledges, relying on Article 82 MDR risks creating a patchwork of national procedures, undermining legal certainty and potentially compromising patient safety. Building on Article 62 instead means the Italian model can be replicated by other Member States without requiring any regulatory exception.
Streamlined authorisation
The centrepiece of the new framework is a fast-track authorisation pathway built specifically for EFS.
This offers accelerated timelines at a maximum of 30 to 45 days for final authorisation, against a standard timeframe of 60–90 days. Validation timelines would also drop, from the current 10–55 days down to 7–39, in line with the HEU-EFS project methodology.
Under the pathway, authorisation fee for EFS would be abolished entirely, removing what has been a real barrier for SMEs and start-ups, and aligning Italy with best European practice.
Other protoclls include a single ethics committee, with this centralised review eliminating the duplication that currently slows down multi-site or complex device studies.
Furthermore, adaptive protocols and modular approval mean that procols can be structured in sequential modules, with each module requiring only targeted re-authorisation, not a full re-submission.
Finally, proportionate documentation will be permitted, with the dossier calibrated to the exploratory nature of the study, meaning: a reduced Clinical Evaluation Plan, a simplified Risk Management Plan under ISO 14971, and clear patient information materials. No more forcing a pivotal-trial dossier onto an early-stage study.
The broader vision
The EFS pathway is only one piece of a larger architecture. The Guidelines identify four interconnected pillars for Italy’s innovation governance: (1) the EFS programme itself; (2) a Priority Review pathway for breakthrough devices; (3) alignment with the National HTA Programme (PNHTA) under EU Regulation 2021/2282; and (4) a dedicated State Fund for the procurement of innovative devices that improve healthcare system quality, modelled on what already exists for pharmaceuticals, and designed to allow Italian regions to acquire innovative devices outside their medical device spending caps.
While this end-to-end approach is notable, important details remain to be clarified, particularly regarding the scale, governance, and timing of the proposed funding mechanisms.
The Guidelines propose a dedicated regulatory track – activated at the manufacturer’s request – for devices treating life-threatening or severely debilitating conditions, addressing unmet clinical needs, or offering significant advantages over existing solutions. The proposed architecture is concrete: a maximum of 120 days, involvement of Notified Bodies, technical coordination with the European Commission, and CE marking under the MDR – through Notified Bodies – for Class III and IIb devices. What makes this more than a national aspiration is the European context in which it sits. In December 2025, two months before the Italian Guidelines were published, the European Commission tabled its legislative proposal to amend the MDR and IVDR (COM(2025)1023), introducing for the first time dedicated pathways for Breakthrough Devices and Orphan Devices under a new Article 52a. The MDCG has already published its guidance on Breakthrough Technologies (MDCG 2025-9), and the EMA is launching a pilot programme for expert panel advice on breakthrough devices in Q2 2026. Italy’s proposal therefore does not sit in isolation; it anticipates and aligns with a legislative trajectory that is already underway at EU level.
In the meantime, China’s NMPA reportedly cleared over 100 devices through its “Green Channel” in 2025 and halved clinical trial approval timelines to 30 working days. South Korea’s “Market Immediate Entry” fast-track, launched in January 2026, compresses time-to-clinical-use from 490 to 80 days. Japan continues to expand its Sakigake and conditional early approval programmes. If Europe wants to remain competitive, dedicated pathways for breakthrough devices are no longer optional.
The European dimension
Italy’s framework is structurally linked to the HEU-EFS project (Harmonised Approach to Early Feasibility Studies for Medical Devices in the European Union) – a Horizon Europe Innovative Health Initiative consortium, led by Italy, tasked by the European Commission with developing a harmonised EFS methodology across the EU. The national Guidelines are fully consistent with HEU-EFS in process, timelines, templates, and KPIs, and the Clinical Investigation Plan template and checklist have been developed and advanced within the HEU-EFS framework. With the Commission’s December 2025 proposal now introducing Breakthrough and Orphan Device pathways into the MDR itself, Italy is piloting what could become the European standard.
If successfully implemented, this could provide a basis for greater harmonisation across Member States, although uptake will depend on alignment not only of rules, but also of administrative capacity and market incentives.
What this means for international sponsors
For MedTech companies planning their next early-stage clinical programme in Europe, the practical package is now concrete: a clear legal basis; authorisation in 30–45 days with no filing fee; adaptive, modular protocols; access to IRCCS, university hospitals, and clinical centres with genuine expertise in innovative device trials; and alignment with a European harmonisation project. The Analytical Code also envisions a mapped network of qualified clinical investigation sites, searchable by therapeutic expertise, infrastructure, and track record, a practical tool for international sponsors approaching Italy for the first time.
Conclusion
These Guidelines stand out not only for their ambition, but also for their completeness. The four pillars – EFS, Priority Review, HTA integration, and a dedicated innovation fund – show that Italy has taken into account the entire chain, from early clinical testing to market access and procurement. The legal architecture appears solid, grounded in Article 62 rather than some national workaround. The operational tools are ready to be tested. And the timing could not be better: with the Commission’s MDR revision now on the table and the MDCG breakthrough pilot launching this year, Italy’s framework is positioned to potentially become a reference model. In a globally competitive landscape for early-stage device trials, Europe needs countries willing to lead, and Italy has taken a significant step in that direction.
