Italy Medical Device Registration

Comprehensive Guide to Medical Device Registration in Italy: Regulations, Process, and Market Overview

Regulatory Authority

Directorate General for Medical Devices, Pharmaceutical Services and Safety in Healthcare (La Direzione generale dei dispositivi medici, del servizio farmaceutico e della sicurezza delle cure svolge)

The Directorate General for Medicines and Medical Devices (DG-MED) is the name of the government agency in Italy that is in charge of monitoring and regulating pharmaceuticals and medical equipment. It ensures the safety, efficacy, and quality of medical supplies and drugs in Italy. The DG-MED is also responsible for overseeing the registration, monitoring, and regulation of pharmaceutical products, including both prescription and over-the-counter medications.

Additionally, it is in charge of implantable and diagnostic medical device registration, conformity testing, and post-market supervision. The DG-MED gives instructions for manufacturers to ensure that Italian and EU regulations are being obeyed.

Overview

Italy stands as a well-established market for medical equipment, ranking as the fourth largest in Europe after Germany, France, and the UK. The sector comprises approximately 4,500 companies, with 42% functioning as distributors, 53% as producers, and 5% as service providers, collectively employing over 118,000 individuals. In 2021, the medical device market, encompassing dental and optical devices, reached a valuation of $11.8 billion, with imports contributing $7.8 billion. 

Notably, more than 75% of medical device purchases occur in public hospitals, while the private sector accounts for the remaining 25%. Anticipated market growth may face constraints due to economic deceleration and cost-containment measures, such as the “payback” system, requiring companies to cover government spending surpassing budget limits.

Link for Regulatory Authority

https://www.salute.gov.it/portale/ministro/p4_5_2_4_1.jsp?lingua=italiano&menu=uffCentrali&label=uffCentrali&id=1153

Local Regulations

Decreto 21 dicembre 2009

Classification of Medical Device

Class I, IIa, IIb III

Listing or Registration Requirements

1. First notification
   The “First notification” for a medical device must be completed within 30 days with an electronic signature. Missed deadlines or lack of electronic signature result in data deletion, including the system-assigned progressive number in the BD/RDM system.
2. Subsequent notifications
   “Subsequent notifications” for medical device changes must be electronically signed within 7 days of “return to processing.” If not, the changes are nullified, deleted, and the previous notification remains valid.

Documents Required for Registration

• Name and code of the medical device, its classification, name of the Manufacturer or its authorized representative
• Brief description of the medical device together with its intended use, a list of the materials contained in the medical device that comes into direct contact with the patient, sterilization data, information about re-use, scientific bibliography, and other information.
• CE Conformity Certificates
• EC Declaration of Conformity
• Packaging box (Box, Labelling and instructions for use)
• Technical file
• Scientific bibliography supporting the clinical evidence of the effectiveness and safety of the device
• Data Sheet
• Commercial Data
• Signed and stamped copy of C-17 form 

Registration Timeline

30 – 45 Days

Registration Fee

No fees

License Validity

5 Years

Special Labeling Requirements

DoC, labelling and IFUs must be in Italian

Market overview

In 2024, the Medical Devices market in Italy is anticipated to achieve a revenue of US$12.85 billion, with the largest market segment expected to reach US$1.75 billion, contributing to an overall market volume of US$182.00 billion. Looking forward, a steady annual growth rate of 3.79% (CAGR 2024-2028) is projected, leading to a market volume of US$14.91 billion by 2028. 

The United States is forecasted to dominate the global Medical Devices market, generating the highest revenue of US$182.00 billion in 2024. Italy’s surge in demand for cutting-edge technologies and a heightened emphasis on telemedicine solutions is contributing to the growth of its medical device market.

Additional Comments

In Italy, medical device registration involves no set fees, but requires manufacturers outside the EU to appoint an Authorized Representative. While the full transition to the new Medical Device Regulation (MDR) occurred in May 2022, some aspects still utilize the national database due to ongoing system updates. 

Registration timelines vary depending on device class, and associated costs may include notified body fees, translations, and consultancy services. For the latest regulations and specific device requirements, always consult the Ministry of Health website or seek professional guidance.

Who should make this Communication?

• Manufacturer
• Authorised Representative

When to make this Communication?

Before placing a medical device into the market.

Why Choose Us?

• Working towards client satisfaction
• Cost effective solutions
• Project completion before deadline
• Quality Regulatory affairs solutions

Contact us for free consultation: info@omcmedical.co.uk