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Ministry of Health market access

Italy medical device registration resources

Research Ministry of Health registration records, classification, regulations, timelines, fees, and market updates — the stable entrance to every Italy medical device resource.

5 free resources22/25 topics with recordsAug 2026 fees reviewed
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Medical device regulation news

Follow recent Ministry of Health — Directorate-General for Medical Devices and Pharmaceutical Service policy, guidance, safety, and compliance updates.

AI medical device classifier

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Government registration fees

Check current AIFA fee requirements for device market entry.

Additional certification and licence checker

Check whether product features may trigger separate radio, electrical, metrology, radiation, import, or other Italy requirements.

Registration timeline

Compare the statutory notified-body conformity assessment clock under Regulation (EU) 2026/977 with realistic CE marking times by device class.

Structured regulatory requirements

Explore all 48 source-linked facts →

22 of 25 research dimensions currently covered · 19 official sources · latest verification 2026-09-15

Market entry

D01

Authority & regime

Verified
Competent authority
The Ministry of Health (Ministero della salute) is designated competent authority for medical devices under MDR Art. 101; every MDR reference to the Member State competent authority means t…
Role split with other national authorities
Where the MDR refers to the national competent authority for medicinal products, this means AIFA (Italian Medicines Agency). The Ministry of Economic Development (now MIMIT) remains the nat…
2 source-linked facts
Checked 2026-08-25
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D02

Legal basis & guidance

Verified
Legacy devices — national rules transition (expired)
For devices under MDR Art. 120(3) (4) (legacy directives certificates / devices placed on market before 26 May 2021), national rules continued to apply only to the extent necessary until 27…
National implementation decrees
Italy's national implementation framework consists of D.Lgs. 5 agosto 2022 n. 137 (adaptation to MDR (EU) 2017/745 and (EU) 2020/561, under Art. 15 of Law 53/2021) and D.Lgs. 5 agosto 2022…
2 source-linked facts
Checked 2026-08-25
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D03

Device definition & scope

Verified
National definition of 'reclamo' (complaint)
The national decree adopts the MDR Art. 2 definitions and adds one national definition: 'reclamo' (complaint) — a written, electronic or oral communication declaring deficiencies related to…
1 source-linked fact
Checked 2026-08-25
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D04

Classification rules

Verified
EU MDR classes I, Is, Im, Ir, IIa, IIb and III
Class I, Class Is, Class Im, Class Ir, Class IIa, Class IIb, Class III
1 maintained scheme · 1 related fact
Checked 2026-08-26
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D05

Registration pathways

Verified
Custom-made devices — manufacturer communication to Ministry
Manufacturers placing custom made devices on the Italian territory must communicate to the Ministry of Health their identifying data and the list of the devices. Data changes must be update…
Market-access route or official registration surface
Registration surface is EUDAMED: manufacturers, authorised representatives and importers must register in the EUDAMED economic operator system before placing a non custom device on the mark…
2 source-linked facts
Checked 2026-08-25
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D06

Reliance & recognition

Verified
NMPA certificate does not replace EU conformity assessment
statement: For ordinary market placement under MDR/IVDR, a Chinese approval does not replace conformity assessment under MDR Article 52 or IVDR Article 48. The applicable EU class and proce…
EU CE under MDR/IVDR — single market validity
target: geo:ita · sourceApproval: EU CE under MDR/IVDR · edgeType: single market validity · marketAccessStrength: direct · regulatoryLayer: product marketing · sameDeviceRequired: Yes · loc…
2 source-linked facts
Checked 2026-09-15
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D07

Economic-operator roles

Verified
EUDAMED registration duty of manufacturers, ARs and importers
Manufacturers, authorised representatives (mandatari) and importers must register, under their own responsibility, in the EUDAMED economic operator electronic system before placing on the m…
1 source-linked fact
Checked 2026-08-25
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D08

Establishment, import & distribution

Verified
Distance selling — website blocking enforced by NAS Carabinieri
For devices offered by distance selling to the public online, the Ministry of Health is the authority competent to issue measures preventing access to internet addresses of websites identif…
Distributor registration in the national database
A distributor making non custom medical devices available on the Italian territory must register in the national database (banca dati nazionale) operating at the Ministry of Health, conferr…
3 source-linked facts
Checked 2026-08-25
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D09

Dossier requirements

Verified
Language of conformity-assessment documentation
All documents for MDR Art. 52 conformity assessment procedures (including technical documentation and audit/evaluation/inspection reports) must be drafted in Italian or in another EU langua…
Italian notified bodies — designation documents in Italian
A notified body established in Italy must draft the documents indicated in MDR Arts. 38 and 39 (application for designation and designation documentation) in Italian.
2 source-linked facts
Checked 2026-08-25
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D10

Official forms & portals

Verified
NSIS national procedures continue until EUDAMED mandatory notice
Until publication of the European Commission notice under MDR Art. 34(3) (EUDAMED mandatory use), the national provisions continue to apply for devices placed on the market under MDR Arts.…
1 source-linked fact
Checked 2026-08-25
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Submission & evidence

D11

Label, IFU & language

Verified
Field safety corrective action notice in Italian
The manufacturer must provide the safety notice (avviso di sicurezza) to the Ministry of Health in Italian; the Ministry assesses risks from reports received and the proposed safety notice…
Italian language for information supplied with IVDs
All information and indications for any type of IVD supplied in writing by the manufacturer to the user and the patient pursuant to IVDR Annex I (paragrafo 20) must be expressed in Italian…
5 source-linked facts
Checked 2026-08-25
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D12

QMS, audit & inspection

Verified
Manufacturer quality management system (Art. 10(9))
Manufacturers must establish, document, implement, maintain, keep up to date and continually improve a quality management system that ensures compliance with the Regulation in the most effe…
1 source-linked fact
Checked 2026-08-29
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D13

Standards, testing & ancillary approvals

Unresolved
MDR electrical safety in place of the Low Voltage Directive
Electrical safety
MDR electromagnetic compatibility in place of the EMC Directive
EMC
D.Lgs. 128/2016 radio equipment market access
Wireless / radio
8 maintained overlays
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D14

Fees

Unresolved
Annual contribution to the national health service (SSN) on device turnover
0.75% of net-of-VAT SSN turnover contribution
1 maintained fee line · 1 related fact
Checked 2026-08-25
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D15

Review clocks

Unresolved
Class I · Self-declaration (no notified body)
0 days
1 maintained pathway · 1 related fact
Checked 2026-08-29
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D16

Approval validity & renewal

Verified
Distributor data confirmation — annually then every two years
Distributors registered in the national database must confirm the accuracy of the data communicated to the Ministry of Health within one year of first conferring the information, and subseq…
1 source-linked fact
Checked 2026-08-25
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Lifecycle & post-market

D17

Change control

Verified
Distributor data changes — 30-day update duty
In case of modification of the communicated data or cessation of activity, the distributor must update the information in the national database within 30 days of the date of the modificatio…
1 source-linked fact
Checked 2026-08-25
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D18

UDI, listing & traceability

Verified
Health institutions must record and retain UDI
Health institutions (istituzioni sanitarie) and health professionals must record and retain the Unique Device Identifier (UDI) of the devices they have received; detailed arrangements are s…
Implantable device registries — operator data duty
To enable traceability of implantable devices on the national territory, economic operators must provide, as prescribed, the data required by the decrees governing the implantable device re…
3 source-linked facts
Checked 2026-08-25
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D19

Clinical investigation & performance

Verified
Ethics committee favourable opinion required
The national clinical investigation application (for non CE devices and CE devices under MDR Art. 74(2)) must include the favourable opinion of the competent ethics committee; the national…
Clinical investigation — prior communication to Ministry
No clinical investigation may be started without sending a suitable communication to the Ministry of Health and without the conditions for starting the investigation being fulfilled; nation…
2 source-linked facts
Checked 2026-08-25
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D20

Special access & derogation

Verified
Derogation authorization (MDR Art. 59(1))
In exceptional cases of necessity and urgency under MDR Art. 59(1), the Ministry of Health may authorize, on duly motivated request, placing on the market or putting into service in Italy o…
Single-patient exceptional use of non-CE devices
For treatment of single patients, in exceptional cases of necessity and urgency and absent valid medical alternatives, the Ministry of Health — with modalities set by a specific Ministerial…
2 source-linked facts
Checked 2026-08-25
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D21

Manufacturer PMS

Verified
Post-market surveillance reporting (Arts. 83-86)
Manufacturers must implement a post market surveillance system (Art. 83) and a documented post market surveillance plan proportionate to the risk class and appropriate to the type of device…
1 source-linked fact
Checked 2026-08-29
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D22

Vigilance & incident reporting

Verified
Complaints reported to manufacturer with concurrent copy to Ministry
Public or private health operators, directly or via the health structure involved, must report complaints (reclami, Art. 2(2)(a)) to the manufacturer — also via the relevant economic operat…
Health operators must report serious (even suspected) incidents
Public or private health operators who, in their activity, detect a serious incident as defined by MDR Art. 2(1)(65) — even if only suspected — involving a medical device must report it to…
4 source-linked facts
Checked 2026-08-25
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D23

Recall, FSCA & market surveillance

Verified
Ban/withdrawal/recall measures at operator expense
Where a violation is ascertained, the Ministry orders the manufacturer, mandatario and all interested economic operators to take every suitable action to end the infringement within a clear…
Market surveillance delegated to the Ministry of Health
Market surveillance of the decree is delegated to the Ministry of Health, which may order checks via its central and peripheral offices and specially appointed entities; checks may be carri…
2 source-linked facts
Checked 2026-08-25
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D24

Advertising, claims & promotion

Verified
Information addressed to health professionals exempt from authorization
Information addressed to health operators (operatori sanitari) does not require authorization and is carried out in compliance with the modalities identified by Ministry of Health guideline…
Ministry authorization for public advertising of other devices
Without prejudice to MDR Art. 7, advertising to the public of devices other than the banned categories is subject to authorization by the Ministry of Health; applications are reviewed by th…
3 source-linked facts
Checked 2026-08-25
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D25

Submission communications & appeal

Verified
Prior counter-arguments before denial or restriction measures
Before adoption of any denial or restriction measure (including clinical investigation measures, bans or limitations on placing on the market, making available, withdrawal or recall), the a…
Decisions notified with appeal deadline indication
Denial and restriction measures (including urgent ones) are notified to the interested party with an indication of the deadline within which an appeal (ricorso) may be brought.
4 source-linked facts
Checked 2026-08-25
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Government fees

Full fee schedule (1 lines) →

AIFA registration fees in EUR · reviewed 2026-08-25

Fee lineAmountProvenance
Annual contribution to the national health service (SSN) on device turnover0.75% of net-of-VAT SSN turnover contributionPlanning estimate

Registration timeline

Full registration timeline →

Italian Ministry of Health (Ministry of Health) review clocks and planning ranges · 4-class (I, IIa, IIb, III) — EU MDR classification

Class / pathwayReview clockPlanning totalProvenance
Class I(Self-declaration (no notified body))0 days6-9 monthsVerified
  1. 1Pre-Submission Preparation(1-3 months)
  2. 2Application Submission(1-2 weeks)
  3. 3Administrative Review(2-4 weeks)
  4. 4Technical Evaluation(0 days)
  5. 5Registration Approval(1-2 weeks)

Latest regulation news

All Italy regulation news →

Newest official Ministry of Health headlines from the daily-refreshed feed — every row links directly to the authority publication.

Sep 9MOMinistry of Health — Directorate-General for Medical Devices and Pharmaceutical ServiceMedical Device Safety Notice: Dexcom G7 App for Android (SW12299)ItalySep 9MOMinistry of Health — Directorate-General for Medical Devices and Pharmaceutical ServiceMedical Device Safety Notice: Dexcom G7 App for iOS (SW12300)Italy
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Italy change notification workpaper

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