Italy Medical Device Registration & Market Access Guide (2026): Ministry of Health, BD/RDM Database, Repertorio & Requirements
Everything you need to know about marketing medical devices in Italy in 2026 — including EU MDR requirements, Ministry of Health national registration via BD/RDM (Repertorio) database, EUDAMED deadlines, Italian-language labeling mandates, national HTA program (PNHTA-DM), clinical investigation procedures, post-market surveillance, and practical market entry guidance for Europe's fourth-largest medical device market.
Overview of Italy's Medical Device Market
Italy is the fourth-largest medical device market in Europe (after Germany, France, and the UK) and one of the most significant healthcare economies in the Mediterranean region. The Italian medical device market was valued at approximately $14.8 billion in 2025 and is projected to reach $23.16 billion by 2034, growing at a CAGR of approximately 5.1%.
Italy's healthcare system — the Servizio Sanitario Nazionale (SSN) — provides universal coverage through a regionalized model, with 20 autonomous regions managing healthcare delivery. This structure means that market access strategies must account for both national registration requirements and regional procurement processes. Public hospitals account for more than 75% of medical device purchases, with the private sector representing approximately 25%.
The country is home to approximately 4,640 medical device companies (32% distributors, 59% producers, and 7.7% service providers), employing over 117,000 people. Italy has a strong domestic manufacturing base, particularly in orthopedics, cardiovascular devices, diagnostic imaging, and rehabilitation equipment. Medical device imports were valued at approximately $9 billion in 2024, creating significant opportunities for foreign manufacturers.
A landmark development for 2026: Italy officially entered the operational phase of the 2026–2028 National HTA Program for Medical Devices (PNHTA-DM) in January 2026, with approximately €13 million allocated from the national medical device governance fund. This program, coordinated by AGENAS, will produce 50–100 HTA reports on high-impact medical devices, with special attention to AI platforms and digital therapeutics.
Key Market Data
| Metric | Value |
|---|---|
| Total market size (2025) | $14.8 billion (~€13.6 billion) |
| Projected market (2034) | $23.16 billion |
| CAGR (2025–2034) | 5.1% |
| Number of companies | ~4,640 |
| MedTech employees | 117,000+ |
| Public hospital share of purchases | >75% |
| Medical device imports (2024) | ~$9 billion |
| Population | ~59 million |
| NRRP healthcare allocation | €15+ billion |
Regulatory Framework
As an EU member state, Italy regulates medical devices primarily under EU-wide legislation, supplemented by national implementing laws and Italian-specific registration requirements.
EU-Level Legislation
| Regulation | Purpose |
|---|---|
| Regulation (EU) 2017/745 (MDR) | Primary legislation for medical devices — classification, conformity assessment, CE marking, clinical evidence, post-market surveillance |
| Regulation (EU) 2017/746 (IVDR) | Primary legislation for in vitro diagnostic devices |
| Commission Implementing Decision (EU) 2025/2371 | Declares EUDAMED mandatory from 28 May 2026 |
National Legislation
| Law | Purpose |
|---|---|
| Decreto Legislativo 26 settembre 2007, n. 219 | Transposes EU directives on medical devices into Italian law (as updated for MDR) |
| Decreto Legislativo 14 dicembre 2017, n. 137 | Implements the EU MDR and IVDR into national legislation |
| Decreto 27 marzo 2023 | Updated provisions for the Repertorio Nazionale dei Dispositivi Medici (national device register) |
| DM 26 gennaio 2024 | PNHTA-DM 2024–2025 framework for health technology assessment of medical devices |
| Decreto del Ministero della Salute (PNHTA-DM 2026–2028) | Operational phase launched January 2026 for national HTA program |
Key Regulatory Authorities
| Authority | Role |
|---|---|
| Ministero della Salute (Ministry of Health) | Directorate General for Medical Devices and Pharmaceutical Services — primary competent authority for national device registration |
| BD/RDM (Banca Dati dei Dispositivi Medici / Repertorio) | National Medical Devices Database — mandatory registration of all devices placed on the Italian market |
| AGENAS (Agenzia Nazionale per i Servizi Sanitari Regionali) | National Agency for Regional Health Services — coordinates the national HTA program (PNHTA-DM) |
| ISS (Istituto Superiore di Sanità) | National Institute of Health — provides scientific and technical support for device evaluation |
| AIFA (Agenzia Italiana del Farmaco) | Italian Medicines Agency — regulates pharmaceutical products (not medical devices, but involved in combination products) |
| Regional Health Authorities | 20 autonomous regions manage procurement, reimbursement, and healthcare delivery within their jurisdictions |
CE Marking and Market Access
All medical devices placed on the Italian market must bear the CE mark in accordance with the EU MDR. CE marking is the gateway, but Italy requires a mandatory national registration in the Repertorio database before devices can be distributed through the National Health Service.
Steps to Market Access in Italy
Step 1: Classification (MDR Annex VIII)
- Classify your device under MDR rules (Class I, IIa, IIb, III)
- Classification is based on intended purpose, duration of contact, invasiveness, and active nature
Step 2: Conformity Assessment
- Class I (non-sterile, non-measuring, non-reusable surgical): Self-declaration by the manufacturer
- Class Is, Im, Ir, IIa, IIb, III: Involvement of a Notified Body is mandatory
- The Notified Body assesses your quality management system and technical documentation
Step 3: Technical Documentation
- Prepare a complete technical file in accordance with MDR Annexes II and III
- Include clinical evaluation, risk management, labeling, and instructions for use
Step 4: Declaration of Conformity and CE Marking
- Issue the EU Declaration of Conformity
- Affix the CE mark to the device and packaging
- Include the Notified Body number (for Class Is and above)
Step 5: National Registration (BD/RDM — Repertorio)
- Register the device in the Italian BD/RDM (Banca Dati dei Dispositivi Medici) national database
- Registration is mandatory for all device classes
- A unique identification number (numero di Repertorio) is issued upon successful registration
Step 6: Appoint Authorized Representative (if non-EU)
- Manufacturers outside the EU must appoint an EU Authorized Representative
- U.S. and other non-EU manufacturers should designate a local third party in Italy to handle registration
BD/RDM National Registration (Repertorio)
Italy maintains one of the most comprehensive national medical device databases in the EU. The BD/RDM (Banca Dati dei Dispositivi Medici / Repertorio Nazionale) is administered by the Ministry of Health and is mandatory for all medical devices placed on the Italian market.
Registration Process
- Access the BD/RDM portal on the Ministry of Health website
- Enter manufacturer and Authorized Representative details
- Input comprehensive device data:
- CE certification details and Notified Body information
- Device classification and CND (Classificazione Nazionale dei Dispositivi medici) code
- UDI (Unique Device Identification) data
- Intended use and technical specifications
- Upload supporting documentation:
- CE certificate
- Declaration of Conformity
- Technical documentation summary
- Risk classification justification
- Italian translations of IFU and labeling
- Submit for validation by the Ministry of Health
- Receive the numero di Repertorio (Repertorio number) — a unique identification number required for all commercial activities
Registration Timelines
| Device Class | Typical Timeline |
|---|---|
| Class I (complete submission) | 30–45 days |
| Class IIa | 45–60 days |
| Class IIb/III (requiring additional review) | 60–90 days |
Timelines can be extended if authorities request clarification or additional documentation during the review process.
Key Points
- Registration is in the name of the manufacturer, even if submitted by a distributor or Authorized Representative
- The Repertorio number must be referenced in all communications with Italian authorities
- The number must be maintained throughout the product lifecycle, including updates and modifications
- Devices not registered in the Repertorio cannot be distributed through the Italian National Health Service (SSN)
EUDAMED Registration
Under Commission Implementing Decision (EU) 2025/2371, the first four EUDAMED modules become mandatory on 28 May 2026. Italy is aligning its national systems with EUDAMED, though the BD/RDM remains the primary national database.
EUDAMED Modules and Deadlines
| Module | Content | Mandatory From |
|---|---|---|
| Actors | Registration of manufacturers, ARs, importers, sponsors | 28 May 2026 |
| UDI/Devices | Device registration with UDI data | 28 May 2026 |
| NB/Certificates | Notified Body certificate registration | 28 May 2026 |
| Market Surveillance | National authority market surveillance data | 28 May 2026 |
| Clinical Investigations | Under development | TBD |
| Vigilance | Under development | TBD |
Key Deadlines for Italy
| Deadline | Requirement |
|---|---|
| 28 May 2026 | All economic operators must be registered as Actors in EUDAMED. New MDR/IVDR devices must be registered in UDI/Devices before being placed on the Italian market |
| 28 November 2026 | Legacy devices and devices already on the market before 28 May 2026 must be registered in EUDAMED |
| 28 May 2027 | Notified Bodies must register all MDR/IVDR certificates issued before the mandatory use date |
Italian-Specific Requirements
While most requirements derive from the EU MDR, Italy imposes several additional national obligations.
1. Italian-Language Labeling and Documentation
Italy requires that all labeling, instructions for use (IFU), and safety information be provided in Italian. This is mandatory under Italian consumer protection law and national medical device legislation.
- Labels and packaging: Must be in Italian
- Instructions for Use (IFU): Must be provided in Italian
- Technical documentation: May be submitted in English to the Notified Body, but Italian translations are required for the BD/RDM submission
- Promotional materials: Must comply with Italian advertising regulations
2. CND Classification
Italy uses the CND (Classificazione Nazionale dei Dispositivi medici) system, a national classification code that must be assigned to every device registered in the Repertorio. The CND code provides detailed categorization beyond the MDR risk class and is used for procurement and expenditure tracking by the SSN.
3. Clinical Investigations in Italy
Clinical investigations in Italy are governed by MDR Articles 62–82 and the national legislation. Key requirements:
- Ethics Committee approval must be obtained before submitting to the competent authority
- Applications are submitted to the Ministry of Health and the relevant local ethics committee
- Italy requires adequate insurance coverage for clinical investigation participants
- The ISS (Istituto Superiore di Sanità) provides scientific and technical support
4. Post-Market Surveillance and Vigilance
Italy operates within the EU vigilance framework while maintaining national oversight:
- Serious incidents: Must be reported to the Ministry of Health within MDR timelines
- Field Safety Corrective Actions (FSCAs): Must be reported before or at the time of implementation
- Periodic Safety Update Reports (PSURs): Required under MDR Article 86
- National NSIS data flows: The Sistema Nazionale Informazioni Sanitarie (NSIS) tracks device consumption data across Italian regions
5. NRRP Investment Program
Under Italy's National Recovery and Resilience Program (NRRP/PNRR), the healthcare sector has received over €15 billion in funding:
- €1.18 billion allocated to replace obsolete medical equipment (3,133 devices including CT scanners, MRI machines, linear accelerators, angiography systems, PET scanners, mammography units, and ultrasound devices) — procurement is 90% completed
- €1.45 billion invested in digitalization of 280 hospitals, including laboratory information systems, pharmacy services, emergency rooms, and diagnostics
This creates significant procurement opportunities for manufacturers of advanced imaging and diagnostic equipment.
6. National HTA Program (PNHTA-DM 2026–2028)
In January 2026, Italy launched the operational phase of its National HTA Program for Medical Devices (PNHTA-DM), coordinated by AGENAS with approximately €13 million in funding. Key features:
- 50–100 HTA reports planned for 2026 on devices with high clinical, organizational, and economic impact
- Special focus on AI platforms and digital therapeutics
- Systematic implementation of appraisal processes to support policy and procurement decisions
- Integration with real-world data, clinical outcomes, and value-based procurement models
- Collaboration with regional health authorities for evidence generation
Fees and Costs
Italy does not charge a separate registration fee for the BD/RDM Repertorio registration. However, overall market entry costs include EU-wide conformity assessment costs and Italian-specific expenses:
| Item | Estimated Cost |
|---|---|
| BD/RDM Repertorio registration | No fee (database entry) |
| EUDAMED registration | No fee (EU system) |
| Notified Body assessment (Class IIa–III) | €15,000–€100,000+ depending on device class and complexity |
| Italian-language translation (labeling/IFU) | €2,000–€25,000 depending on device complexity |
| EU Authorized Representative (for non-EU manufacturers) | €3,000–€15,000/year |
| Local third-party registration support | €2,000–€8,000 per registration |
| Clinical investigation in Italy | No Ministry application fee; study costs vary widely |
Total Estimated Cost to Market in Italy (CE Marking Included)
| Route | Estimated Total Cost |
|---|---|
| Class I (self-declaration) | €5,000–€20,000 (documentation, translations, AR, Repertorio registration) |
| Class IIa (via Notified Body) | €20,000–€65,000 (NB fees + documentation + translations + AR + Repertorio) |
| Class IIb/III (via Notified Body) | €50,000–€200,000+ (NB fees + clinical data + documentation + translations + AR + Repertorio) |
Timelines
| Step | Timeline |
|---|---|
| CE marking (Class I, self-declaration) | 1–3 months (documentation preparation) |
| CE marking (Class IIa, via NB) | 6–12 months |
| CE marking (Class IIb/III, via NB) | 12–24+ months |
| BD/RDM Repertorio registration (Class I) | 30–45 days |
| BD/RDM Repertorio registration (Class IIa–III) | 45–90 days |
| EUDAMED Actor registration | 1–4 weeks |
| EUDAMED Device registration | 1–4 weeks per device |
| Total market entry (CE + Repertorio) | Class I: 2–5 months; Class IIa: 7–14 months; Class IIb/III: 13–27+ months |
Note: CE marking timelines are EU-wide, not specific to Italy. The BD/RDM registration runs in parallel after CE marking is obtained.
Practical Tips
Register in the Repertorio early: The BD/RDM registration is mandatory for all device classes and is a prerequisite for distribution through the SSN. Begin preparing documentation as soon as CE marking is underway.
Designate a local representative: For non-EU manufacturers, the U.S. Commercial Service and trade.gov recommend designating a third party in Italy to register products with the Ministry of Health. Local expertise significantly reduces processing time and avoids documentation errors.
Prepare Italian translations carefully: Italian-language IFU and labeling are mandatory. Poor translations are a common cause of registration delays and post-market compliance issues.
Understand regional procurement: Italy's regionalized healthcare system means that procurement decisions are made at the regional level. Develop relationships with regional health authorities and understand local tender processes.
Monitor the PNHTA-DM program: The 2026–2028 HTA program will produce evaluations that influence procurement and reimbursement decisions across Italian regions. If your device is in a high-impact category, early engagement with AGENAS is advisable.
Leverage NRRP procurement opportunities: The remaining 10% of NRRP medical device procurement is still available. Monitor CONSIP (National Procurement Agency) tenders for relevant opportunities.
Prepare for EUDAMED now: The 28 May 2026 deadline is firm. Complete Actor registration (SRN) and begin planning device data migration to EUDAMED.
Key Contacts and Resources
| Resource | URL/Contact |
|---|---|
| Ministero della Salute (Ministry of Health) | salute.gov.it |
| BD/RDM Database (Repertorio) | salute.gov.it/portale/tematiche/dispositivi_medici |
| AGENAS (HTA program) | agenas.it |
| ISS (National Institute of Health) | iss.it |
| CONSIP (National Procurement Agency) | consip.it |
| EUDAMED (EU device database) | ec.europa.eu/tools/eudamed |
Summary Checklist for Market Entry in Italy
- Classify device under MDR (Class I, IIa, IIb, III)
- Complete conformity assessment (self-declaration or via Notified Body)
- Prepare technical documentation (MDR Annexes II & III)
- Issue Declaration of Conformity and affix CE mark
- Translate labeling and IFU into Italian
- Appoint EU Authorized Representative (if non-EU)
- Register as Actor in EUDAMED (obtain SRN)
- Register device in EUDAMED UDI/Devices module
- Register device in BD/RDM Repertorio national database
- Obtain CND classification code
- Designate local third party for Ministry of Health liaison (recommended)
- Implement post-market surveillance and vigilance procedures
- Monitor CONSIP tenders for procurement opportunities
- Engage with PNHTA-DM program if device qualifies as high-impact