Effegi Brega
Sarmato, Italy
Piacenza-area builder of professional equipment for dental laboratories, sold in 30+ countries.
GIMA
Gessate, Italy
Milan-area distributor of medical products and instruments, offering over 10,000 items to medical dealers.
MESA Italia
Travagliato, Italy
Brescia-area producer of dental alloys and IGEA dental implant systems, sold in over 75 countries.
Promed Group
Villanova di Castenaso, Italy
Bologna-area manufacturer and exporter of dental and medical equipment, serving over 40 markets.
Silfradent
Santa Sofia, Italy
Forlì-Cesena manufacturer of medical technologies and dental laboratory equipment, founded in 1975.
Business types in Italy
Cities in Italy
Medical exhibitions in Italy
Regulation in Italy
Italy is in the EU / EEA, so the EU framework applies.
Regulator: European Commission (DG SANTE) with national competent authorities of EU/EEA Member States
Two EU regulations govern medical devices and IVDs in the EU/EEA; devices need CE marking after the conformity assessment route set by their risk class.
From the sourced EU MDR / IVDR entry, checked 29 October 2026. General information, not legal advice. Requirements for Italy · All medical certifications
Frequently asked questions
What technical documentation should an Italian manufacturer hold for an MDR instrument?
Every MDR device, including self-declared Class I devices, needs technical documentation under Annexes II and III. For an instrument this usually includes:
- a device description and specifications, labeling and IFU;
- a checklist of the General Safety and Performance Requirements, with the standards applied;
- the risk management file, biocompatibility, sterilization or reprocessing and performance test reports as relevant;
- a clinical evaluation plan and report, proportionate to risk and updated with post-market data;
- post-market surveillance documentation.
Buyers rarely receive the full file, but can ask for a summary or the GSPR checklist. Italian manufacturers are on the Italy country page; see the medical certifications page.