Compliance vs Conformance in Italy: New Decrees Bring Tougher Penalties for Non-Compliance

Italy has taken a significant step towards harmonizing its laws with EU regulations on medical devices and in vitro diagnostics, introducing new decrees that bring tougher penalties for non-compliance.

Background

The Legislative Decree 137/2022 and Legislative Decree 138/2022 were published in the Italian Official Gazette of September 13, 2022, and aim to create a new legislative framework consistent with EU Regulations 745/2017 and 746/2017.

Penalty Regime

The decrees introduce significant changes to the penalty regime, which is now more detailed and complex than before. The quantum of penalties ranges from a minimum of EUR 20,000 to over EUR 150,000.

• Manufacturers: Failure to have a quality management system or draw up technical documentation can result in sanctions ranging from EUR 24,200 to EUR 145,000.
• Importers and Distributors: Importers who do not keep Declaration of Conformity or EC Certification of the Notified Body may be fined between EUR 20,000 and EUR 120,000. Distributors who modify labels and packaging without following procedure can face penalties ranging from EUR 11,300 to EUR 113,200.

Sanctions for Sponsors and Clinical Investigations

• Sponsors: Failing to provide mandatory notifications or register and report adverse events during clinical investigations can result in fines between EUR 20,000 and EUR 112,000.
• Notification of Clinical Investigations: Failure to notify clinical investigations can result in penalties ranging from EUR 24,200 to EUR 145,000.

Person Responsible for Regulatory Compliance (PRRC)

The decrees make the PRRC directly responsible for regulatory compliance. The PRRC is exposed to penalties ranging from EUR 20,000 to EUR 120,000 if they fail to ensure conformity of devices, technical documentation, post-market surveillance, reporting obligations, and other requirements.

Procedure for Enforcement

The application and calculation of penalties are governed by Article 27 paragraphs 48-54. The procedure for enforcement is that of Law 689/81, and the Competent Authority applies criteria set out in Article 11 of Law No. 689 of 1981.

Impact on Industry

It remains to be seen how these new decrees will impact the industry and whether these measures will be effective in ensuring compliance. However, the aim is to raise the level of control over devices through greater accountability of the PRRC.