Compliance Checklist

CE Marking
Health & Medical
Italy 🇮🇹

CE marking for medical devices and health products on Amazon Italy: MDR requirements, risk classification, the Italian Banca Dati/Repertorio registration, and common mistakes.

Overview

Medical devices and health products in the EU are subject to the Medical Device Regulation (MDR) (EU) 2017/745 or the In Vitro Diagnostic Regulation (IVDR) (EU) 2017/746 – unchanged in Italy as well. CE marking is mandatory for all medical devices. What sets Italy apart from many other EU states is the additional national registration requirement in the Banca Dati/Repertorio Dispositivi Medici (BD/RDM) run by the Ministry of Health (Ministero della Salute): as long as the central EU database Eudamed is not fully operational, national registration remains mandatory for manufacturers and their authorized representatives in Italy, and every product additionally receives a national CND classification code (Classificazione Nazionale dei Dispositivi medici).

Does this apply to my product?

This checklist applies to all economic operators selling medical devices with a medical intended purpose to consumers in Italy via Amazon.it: blood pressure monitors, fever thermometers, blood glucose meters, pulse oximeters, wound care, orthopedic aids, compression stockings, medical masks, TENS devices, hearing aids, and in vitro diagnostics such as pregnancy or self-tests. The registration obligation in the Banca Dati/Repertorio formally rests with the manufacturer or its EU authorized representative; an Italy-based distributor used for registration thereby takes on the role of 'responsabile dell'immissione in commercio' under Italian law (D.Lgs. 46/1997) and bears its own responsibility.

Step-by-Step Guide

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Distinguish medical device vs. wellness product and determine risk class

The first decision is identical EU-wide: is the product a medical device within the meaning of the MDR, and if so, which risk class (I, IIa, IIb, III) does it fall into? This classification determines the entire certification process.

Estimated time: 1-2 Wochen / 1-2 weeks

Intended purpose defined and documentedRequired

A massage device 'for relaxation' is a wellness product (LVD/EMC Directive). The same device 'for treatment of muscle tension' is a medical device under MDR. Wording in the listing, packaging, and manual must be consistent.

Risk classification according to MDR Annex VIII completedRequired

Four risk classes: I (lowest risk), IIa (e.g. blood pressure monitors), IIb (e.g. ventilators), III (highest risk). The 22 classification rules in Annex VIII determine classification.

Classification report with justification of applied rules from MDR Annex VIII

Quality management system (QMS) and clinical evaluation

The MDR requires a complete QMS and clinical evaluation for all medical devices, including Class I – uniform across the EU.

Estimated time: 4-16 Wochen / 4-16 weeks

QMS according to EN ISO 13485:2016 implementedRequired

The QMS must cover design control, risk management, supplier evaluation, complaint handling, CAPA processes, and vigilance reporting.

QMS documentation according to EN ISO 13485

Clinical evaluation according to MDR Article 61 completedRequired

For Class I, a literature review and equivalence assessment is usually sufficient. From Class IIb onwards, clinical investigations may be required.

Clinical Evaluation Report (CER)

Create technical documentation according to MDR Annex II and III

The technical documentation must meet the requirements of MDR Annex II and III and, under MDR Art. 10(8), must remain available for at least 5 years – 15 years for implantable devices – after the last product is placed on the market.

Estimated time: 4-12 Wochen / 4-12 weeks

Technical documentation according to MDR Annex II compiledRequired

Product description, manufacturing information, general safety and performance requirements, risk management file, clinical evaluation, labeling, and instructions for use.

Complete technical documentation according to MDR Annex II

Post-Market Surveillance Plan (PMS Plan) createdRequired

Describes complaint tracking, vigilance reporting, and periodic safety update reports (PSUR from Class IIa).

Conformity assessment and Notified Body (from Class IIa)

From Class IIa onwards, involvement of an MDR-designated Notified Body is mandatory. Italy has its own MDR-designated Notified Bodies, IMQ and TUeV Italia; alternatively, Notified Bodies from other EU states (TUeV SUeD, TUeV Rheinland, DEKRA, BSI) can also be engaged.

Estimated time: 4-26 Wochen / 4-26 weeks

Conformity assessment procedure selected and Notified Body engagedRequired

Check the NANDO database for which Notified Bodies are designated for your product category. Expect several months of lead time for the contract and first assessment.

EU Declaration of Conformity issued and CE marking affixedRequired

The DoC must reference all applied MDR Annexes, the Notified Body identification number (from Class IIa), and the UDI-DI.

EU Declaration of Conformity according to MDR Article 19

Registration in the Banca Dati/Repertorio Dispositivi Medici

As long as Eudamed is not fully operational, national registration in the Banca Dati Dispositivi Medici run by the Ministero della Salute remains mandatory for Italy (established by ministerial decree of 20 February 2007). Every product additionally receives a CND code (Classificazione Nazionale dei Dispositivi medici), which provides a detailed national categorization beyond the MDR risk class and is decisive for Servizio Sanitario Nazionale (SSN) tenders.

Estimated time: 4-8 Wochen / 4-8 weeks

Registration is formally made in the manufacturer's name, even if a distributor or authorized representative submits it technically. Processing time is typically 30-45 days, with Class III products potentially taking several months.

Registration application with product data, CE certificate, and classification

Assign the CND code (Classificazione Nazionale dei Dispositivi medici)Required

The CND code is an Italian classification system in addition to the MDR risk class and is assigned with every registration in the Banca Dati.

Check Repertorio listing if sales to the SSN are planned

Repertorio registration is a subset of the Banca Dati and a prerequisite for participating in tenders by the national health service SSN. It is not mandatory for pure Amazon.it B2C sales but is decisive for B2B business with the SSN.

Italian labeling and Amazon.it listing compliance

Instructions for use, labeling, and promotional materials must be provided in Italian for the Italian market. Amazon.it additionally requires the complete GPSR and compliance mandatory fields per ASIN.

Estimated time: 1-2 Wochen / 1-2 weeks

Instructions for Use (IFU), label, and promotional material created in ItalianRequired

The IFU must meet the requirements of MDR Annex I Chapter III and be provided in Italian. Italian law also requires that all safety-relevant consumer information be provided in Italian. Symbols according to EN ISO 15223-1.

Category approval and GPSR mandatory fields in Amazon Seller CentralRequired

Medical devices on Amazon.it often require category approval (CE certificate, DoC, Notified Body certificate). Additionally, complete the GPSR mandatory fields (responsible person, manufacturer data).

Common Mistakes to Avoid

Wellness product falsely marketed as a medical device (or vice versa)

Consequence: A wellness product marketed with medical claims is legally considered an unauthorized medical device – fines and a sales ban may follow.

Prevention: Define the intended purpose before product development and keep all marketing materials, listings, and packaging consistent with it.

Assuming the national Banca Dati registration is dispensable because the product is in Eudamed

Consequence: As long as Eudamed is not fully operational, the European registration does not replace the Italian Banca Dati obligation. Without a CND code and Banca Dati entry, market surveillance objections and missing access prerequisites for the SSN can result.

Prevention: For every product distributed in Italy, plan for the Banca Dati registration and CND assignment in addition to the Eudamed notification.

Underestimating the Italian distributor's responsibility as 'responsabile dell'immissione in commercio'

Consequence: An Italian distributor through whom registration runs takes on its own legal responsibility under D.Lgs. 46/1997 for the product placed on the market – not just an administrative formality.

Prevention: Clearly regulate the contract with the Italian distributor/authorized representative: who is liable for vigilance reporting, product changes, and keeping Banca Dati entries current.

Confusing the CND code with the MDR risk class

Consequence: The CND code is a separate national classification system and does not replace the MDR risk class (I/IIa/IIb/III) – both are needed for different purposes (conformity assessment vs. national categorization/SSN procurement).

Prevention: Document both classifications separately and consistently reference both codes in registrations and correspondence with authorities.

Instructions for use provided only in English or German

Consequence: Violation of the Italian language requirement for safety-relevant consumer information. Amazon.it can suspend the listing, and competent authorities can intervene.

Prevention: Have the IFU, label, and promotional text professionally translated into Italian before listing on Amazon.it.

Frequently Asked Questions

Q1What is the difference between the Banca Dati and the Repertorio?

The Banca Dati Dispositivi Medici is the Ministero della Salute's central registration database for all medical devices marketed in Italy. The Repertorio is a subset of it and makes product data visible to all market participants – mainly relevant if you also want to sell to the national health service SSN, not mandatory for pure Amazon.it B2C sales.

Q2Who carries out the Banca Dati registration – the manufacturer or the distributor?

Registration is formally made in the name of the manufacturer or its EU authorized representative, even if an Italian distributor submits it technically. The distributor thereby takes on its own responsibility under Italian law as 'responsabile dell'immissione in commercio'.

Q3Do I need a CND code if I only sell on Amazon.it?

Yes, the CND code is assigned with every Banca Dati registration, regardless of the sales channel. It is a separate Italian classification system in addition to the MDR risk class.

Q4How long does registration in the Banca Dati take?

Typically 30 to 45 days. Class I products are usually processed faster, while Class III products can take several months.

Q5Can SpaceGoats help me with medical device compliance for Amazon.it?

Yes, SpaceGoats offers support as an Amazon full-service provider for MDR compliance and coordinating the Italian Banca Dati registration. Contact SpaceGoats at spacegoats.io for individual consulting.

CE MarkingHealth & MedicalItaly 🇮🇹