Italy is one of Europe’s biggest medical device markets, right up there with Germany, France, the UK, and Spain.
But selling a device there takes more than just CE marking. Manufacturers have to follow EU rules under MDR and Italy Medical Device Regulations adds its own requirements on top of it. Miss a step and the device doesn’t move forward.
Understanding how this process works, end to end, matters more than people expect going in. This article explains how the registration process works in Italy, step by step.
Regulatory Authorities for Medical Devices in Italy
The Italian Ministry of Health is the main authority responsible for regulating medical devices in Italy. It handles medical device regulation, market surveillance, post-market vigilance, and national device records.
But the Ministry does not certify most medical devices. Devices above Class I generally require assessment by an EU-designated Notified Body. ACCREDIA accredits these bodies first. The Ministry then officially designates them and publishes them in NANDO, the EU’s notified body database.
An Italian Notified Body is not a requirement. Manufacturers may select any EU-designated Notified Body that covers their device type. Choosing one with the right technical scope and available review capacity can help avoid unnecessary delays.
AIFA only enters the picture for drug-device combination products. For standard devices, it stays out of the process entirely.
Italy Medical Device Classification
Italy follows the EU Medical Device Regulation (EU MDR 2017/745) for medical device classification. There’s no separate Italian classification system. Manufacturers must classify their devices using the rules in Annex VIII of the MDR.
A device is assigned to one of four risk classes based on its intended use, how long it remains in contact with the body, whether it is invasive and the level of risk it presents.
| Class | Risk Level |
| Class I | Low |
| Class IIa | Medium low |
| Class IIb | Medium high |
| Class III | High |
In vitro diagnostics work under a different regulation entirely. Under IVDR, devices run from Class A to Class D, with D reserved for the highest-risk tests. Software and other borderline products need closer reading of the rules.
Whatever class a manufacturer lands on, it needs documented justification in the technical file. That choice determines the assessment route and the Notified Body’s level of involvement.
Authorized Representative (AR) Requirements in Italy
An EU Authorized Representative is required for companies located outside the EU. It is a legal requirement to place the device in the Italian market. It acts as the regulatory point of contact within the EU.
The representative’s name and address must appear on the product label under Annex I, Section 23.2(b) of the MDR.
Since 28 May 2026, the EU AR also plays a role in registrations across two systems:
- EUDAMED, including Actor Registration and UDI/Device Registration
- Italy’s BD/RDM national medical device database
Both registrations should contain consistent information. Differences in the representative’s name or address can delay the registration process.
Medical Device Regulatory Guidelines in Italy
Italy follows EU rules at the core. MDR (2017/745) covers medical devices, IVDR (2017/746) covers in vitro diagnostics. No separate Italian regulation replaces either one.
Italy has also introduced national laws to cover areas left to individual Member States. These includes:
Legislative Decree 137/2022 – covers labeling language, distributor obligations
Legislative Decree 138/2022 – covers advertising controls, enforcement measures
MDCG guidance documents – not binding, but heavily relied on by Notified Bodies and authorities during review
Medical Device Registration Process in Italy
To register a medical device in Italy, manufacturers must complete the EU MDR or IVDR conformity assessment and meet Italy’s national registration requirements. Below is the typical step-by-step registration process.
Step 1: Classify the Device
Confirm whether the product is regulated under the MDR or IVDR. Then determine the correct risk class using the applicable classification rules. The classification should be documented in the technical file because it determines the conformity assessment pathway.
Step 2: Appoint an EU Authorized Representative
This must happen early, since the AR’s written mandate under Article 11(3) affects EUDAMED registration and labeling. The same details should remain consistent across all regulatory records.
Step 3: Set Up a Quality Management System
A QMS isn’t optional. Implement a Quality Management System (QMS) that complies with the MDR. Most manufacturers use EN ISO 13485:2016 to meet these requirements, as it aligns closely with the MDR quality management requirements.
Step 4: Prepare the Technical Documentation
Compile the technical file, including the device description, risk management documentation, General Safety and Performance Requirements (GSPR) checklist, labeling, and post-market surveillance documentation.
Step 5: Complete the Clinical Evaluation
Prepare the required Clinical Evaluation Report (CER). The level of clinical evidence depends on the device type and risk class.
Step 6: Complete the Conformity Assessment
- Class I: Manufacturer self-declaration (except Is, Im, and Ir devices).
- Class Is, Im, Ir, IIa, IIb, and III: Assessment by an EU-designated Notified Body,
where documentation quality often has a direct impact on the review timeline.
Step 7: Prepare the EU Declaration of Conformity
Once compliance is shown, the Declaration gets issued and signed. It is worth double-checking that it actually matches the technical file and CE certificate.
Step 8: Affix the CE Mark
The mark goes on the device or its packaging. If a Notified Body was involved, their ID number goes on too.
Step 9: Register in EUDAMED
Register the manufacturer and other required economic operators in EUDAMED and obtain a Single Registration Number (SRN). Complete the required device registration.
Step 10: Register the Device in BD/RDM
Submit the device information through Italy’s BD/RDM database. Devices supplied to the National Health Service (SSN) may also require registration in the Repertorio.
Step 11: Prepare Italian Labeling
Before placing the device on the market, ensure that the labeling and Instructions for Use (IFU) are available in Italian.
Step 12: Place the Device on the Italian Market
The device can be marketed in Italy after completing the required conformity assessment, registrations, and labeling requirements.
Required Documents for Medical Device Registration in Italy
Manufacturers must prepare both EU regulatory documents for CE marking and Italy-specific registration documents before placing a medical device on the Italian market.
EU regulatory documents typically include:
- Technical Documentation prepared in accordance with MDR Annex II and Annex III
- Risk management documentation
- Clinical Evaluation Report (CER), where applicable
- Post-Market Surveillance (PMS) documentation
- EU Declaration of Conformity (DoC)
- CE Certificate for devices requiring Notified Body certification
- Quality Management System (QMS) documentation
Italy-Specific documents for BD/RDM registration include:
- Device identification and manufacturer information
- EU Authorized Representative details, where applicable
- CE certificate information and UDI data, where relevant
The Ministry of Health can request additional information beyond these documents, depending on the device and how the registration unfolds.
QMS Requirements for Medical Devices in Italy
A compliant Quality Management System is a legal requirement under the EU MDR. There’s no separate Italian requirement here.
The QMS needs to cover:
- Regulatory compliance and risk management
- Clinical evaluation, PMCF and technical documentation
- UDI processes, post-market surveillance, vigilance reporting and CAPA
For most Class I devices, manufacturers maintain the QMS without a Notified Body audit. Classes Is, Im, Ir, IIa, IIb, and III all go through Notified Body review and audit as part of conformity assessment.
Although the MDR does not specifically require ISO 13485 certification. But in practice, most companies build their QMS around EN ISO 13485:2016 because it supports compliance with the MDR. Risk management is another essential part of the QMS, and it is commonly based on ISO 14971:2019.
Medical Device Labeling & IFU Requirements in Italy
Italian is required for both the device label and the Instructions for Use before market entry. Legislative Decree 137/2022 sets this requirement and skipping it brings financial penalties.
Some devices carry extra obligations on top of this. Class III devices and certain implantables need a Summary of Safety and Clinical Performance (SSCP) and this also needs to be available in Italian when the device sells in Italy.
Manufacturers using internationally recognized symbols on labeling need to explain those symbols in the Italian IFU.
Electronic IFUs are allowed for eligible devices, but only under specific conditions. Manufacturers must ensure users can access the electronic version and provide a paper copy free of charge upon request within the required timeframe.
Registration Timelines for Medical Devices in Italy
There’s no standard timeline for medical device registration in Italy. The process follows EU MDR, and how long it takes depends on the device class, technical documentation quality, clinical evidence and how busy your chosen Notified Body happens to be.
| Device Class | Typical Timeline |
| Class I |
Generally quicker because no Notified Body is involved. Exceptions are Class Is, Ir and Im.
|
| Class IIa, IIb, III |
Average 13-18 months from contract signing to MDR certification
|
| EUDAMED |
No formal timeline. Incomplete data delays the process.
|
Early contact with a Notified Body tends to shorten the overall timeline, in our experience. Manufacturers who delay contact until their technical file feels “complete” often end up adding months to their path to the Italian market.
Medical Device Registration Costs in Italy
No government fee applies to BD/RDM registration in Italy. The overall cost of reaching the Italian market comes almost entirely from EU regulatory compliance instead. Notified Body usually takes the largest share of the budget.
Beyond Notified Body fees, manufacturers should plan for:
- QMS development or maintenance
- Clinical evaluation and technical documentation
- Risk management and Italian translations for labels/IFUs
- EU Authorized Representative services, where applicable
Costs shift depending on device complexity and which service providers a manufacturer chooses to work with.
Import Requirements for Medical Devices in Italy
Importing a medical device into Italy involves more than meeting the requirements of the EU MDR. Manufacturers must also complete Italy’s national customs health clearance process before products can enter the market.
Under the EU MDR, the importer must verify that:
- The device bears a valid CE mark.
- A Declaration of Conformity is available.
- A non-EU manufacturer has appointed an EU Authorized Representative (EU AR).
- Labeling compliance, including Italian-language requirements
- UDI requirements have been met, where applicable.
The importer must also place its name and address on the device or packaging, maintain traceability records, keep a copy of the Declaration of Conformity and register as an economic operator in EUDAMED.
Medical devices entering Italy must also pass through the POS 13 health clearance procedure, which is managed by the Italian Ministry of Health together with the Italian Customs Agency. Before customs clearance, the importer must obtain the required authorization code through the Ministry’s system and include it in the customs declaration.
One more requirement worth noticing is that Non-EU manufacturers cannot import products directly. They need an eligible importer in place before shipping anything toward Italy.
Post-Market Surveillance Requirements in Italy
PMS is an ongoing obligation under EU MDR. Manufacturers need to keep monitoring device safety and performance for as long as the device stays on the Italian market.
| Device Class | PMS Document |
Update Frequency
|
| Class I | PMS Report (PMSR) |
Provided to authorities if requested
|
| Class IIa | Periodic Safety Update Report (PSUR) |
Updated as needed, at least every 2 years
|
| Class IIb, III | Periodic Safety Update Report (PSUR) |
Annual updates required
|
Manufacturers must also report serious incidents within the MDR deadlines:
- 2 days for serious public health threat
- 10 days for Death or unexpected, serious deterioration in health
- 15 days for Other serious incidents
When corrective action becomes necessary, manufacturers must notify the Ministry directly and issue a Field Safety Notice to whoever’s been affected. It is also worth noting that Italy still continues to receive vigilance reports directly because the EUDAMED Vigilance and PMS module is not yet mandatory.
Conclusion
Most delays in Italy don’t come from the regulation itself. They come from treating EU compliance and Italian requirements as separate tracks instead of one connected process. BD/RDM registration and vigilance reporting all tie back to what’s already in the technical file and EUDAMED.
Manufacturers who get classification and documentation right early tend to move through the rest faster. If you’re preparing a device for the Italian market, Artixio can help with the medical device registration process. Reach out to us at info@artixio.com.
FAQs
Q1. Is CE marking sufficient to sell medical devices in Italy?
No. CE marking is necessary but not sufficient. Italy also requires registration in the national Ministry of Health database (DB/RDM) before a device can be commercially placed on the Italian market. This applies to all device classes.
Q2. What is the Italy Medical Device Registration Process for non-EU manufacturers?
Non-EU manufacturers must first designate an EU Authorized Representative under MDR Article 11. The AR then handles the national database registration on the manufacturer’s behalf and serves as the contact point for Italian authorities. The manufacturer must still complete CE marking through the applicable conformity assessment route.
Q3. Is EUDAMED registration currently required for the Italian market?
Economic operator registration in EUDAMED (Single Registration Number) is required as of 28 May 2026. While complete device registration via EUDAMED remains in a transitional phase until the system is fully functional, manufacturers must fulfill their Italian registration requirements through the Ministry of Health’s national DB/RDM database. The status of EUDAMED’s full rollout should be monitored through official European Commission communications.
Q4. Are there government fees for Medical Device Registration in Italy?
The Italian Ministry of Health does not charge a direct fee for national DB/RDM database registration, but manufacturers should budget for other essential expenses. These include costs for EU Authorized Representative (AR) services, Notified Body certification, clinical evaluations, and Quality Management System (QMS) audits. Additionally, fees for translating documentation into Italian are separate. Total budget varies based on the specific service providers chosen as well as the class and complexity of the medical device.
