Bquadro
Asti, Italy
Asti-based dental company (Astidental di Sabbione S.p.A.) that distributes and, since 2017, produces products and solutions for dental practices and laboratories.
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Medical Instrument Companies in Asti, Italy
Business types in Asti
Verified specialties in Asti
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.