February 4, 2022

Medical Devices Regulation: Note issued by the Ministry of Health to regulate the transition period

On November 12, 2021, the Ministry of Health published a note (“Note”) providing guidance on the provisions of Legislative Decree No. 46/1997 that shall still be considered applicable following the date of the application of Regulation (EU) 2017/745 (the “Regulation”) on medical devices and the issuance of the legislative decrees envisaged by Article 15 of Delegation Law No. 53/2021.

Specifically, the Note addresses the following main topics: operation of the National Medical Devices Database, custom-made devices, legacy devices, notified bodies, fees, advertising, harmonized rules, products in Annex XVI of the Regulation, and sanctions. Below is a summary of salient points.

National Medical Devices Database

Until Eudamed is fully operational, the previous legislation will apply to assure compliance with obligations on the exchange of information, including the registration of economic operators and devices. Therefore, the National Medical Devices Database will continue to be used.

The Note also clarifies that, until otherwise indicated by the Ministry, the national database does not provide the opportunity to record information relating to importers (as required by Article 31 of the Regulation).

Beginning December 1, 2021, the National Medical Devices Database, established pursuant to Article 13 of Legislative Decree 46/97, was adapted structurally to allow manufacturers and their agents to fulfill the obligations of registration of CE marked medical devices pursuant to the Regulation, until such time as Eudamed is fully operational.

Legacy devices

The Note specifies that “legacy devices” are subject to the provisions of the regulation on post-marketing surveillance, market surveillance, surveillance, registration of economic operators and devices, and certification notifications that replace the corresponding provisions of the directives.

The exemption applicable to “legacy devices” does not apply to (i) class I devices pursuant to the Regulation, already classified as class I pursuant to Directive 93/42/EEC; (ii) custom-made devices; and (iii) those devices that fell within the scope of the directives, but do not fall within the scope of the Regulation.

Advertising

According to the Note, Article 21 of Legislative Decree No. 46/97 shall continue to apply to advertising of medical devices insofar as it is compatible with Article 7 of the Regulation, which states: “In the labelling, instructions for use, making available, putting into service and advertising of devices, it shall be prohibited to use text, names, trademarks, pictures and figurative or other signs that may mislead the user or the patient with regard to the device’s intended purpose, safety and performance by: a) ascribing functions and properties to the device which the device does not have; b) creating a false impression regarding treatment or diagnosis, functions or properties which the device does not have; c) failing to inform the user or the patient of a likely risk associated with the use of the device in line with its intended purpose; d) suggesting uses for the device other than those stated to form part of the intended purpose for which the conformity assessment was carried out.

The Note also specifies that the provisions relating to authorization procedures for advertising in the field of medical devices continue to be valid and applicable. Therefore, prior authorization of the Ministry of Health is still required by the Ministry itself.

However, it is unclear whether the advertising of medical devices that can be used by prescription or with the assistance of an HCP only is still prohibited.

Notified bodies

As of May 26, 2021, the notified bodies designated under the directives are no longer authorized to issue new certificates under the directives. However, the notified body that legitimately issued certification pursuant to the directives prior to May 26, 2021 continues to be responsible for the appropriate oversight of all requirements relating to the devices it has certified; this is regardless of whether or not the body in question has submitted an application to be designated under the Regulation and/or has a designation still valid under the directives during the period when certificates issued under them remain valid. The body is therefore required to practice regular oversight, including on-site inspections with and without notice and the monitoring of any significant changes. In carrying out oversight under certificates issued pursuant to the directives, the body itself is subject to the oversight of the Ministry of Health, as the Ministry is the authority responsible for notified bodies. Therefore, until May 27, 2024, Implementing Regulation (EU) No. 920/2013 of the Commission continues to apply solely in relation to the requirements relating to notified body oversight and monitoring.

Fees

The fees in the extant ministerial decrees, previously submitted to the European Commission, shall continue to apply until the new fees for authorities’ performance of activities provided by the Regulation are established pursuant to Article 111 of the Regulation.

Sanctions

With regard to sanctions, the Regulation reads: “Member States shall lay down the rules on penalties applicable for infringement of the provisions of this Regulation and shall take all measures necessary to ensure that they are implemented. The penalties provided for shall be effective, proportionate, and dissuasive. The Member States shall notify the Commission of those rules and of those measures by 25 February 2020 and shall notify it, without delay, of any subsequent amendment affecting them.

According to the Note, pending the establishment of the sanctions to be associated with the new system provided for in the Regulation or amendment of the existing ones, Article 23 of Legislative Decree No. 46/97 and Article 10 of Legislative Decree 507/92 (relating to active implantable medical devices) shall remain in force.

In particular, the Note specifies that the sanctioning provisions contained in the legislation implementing Directive 93/42/EEC and Directive 90/385/EEC remain in force, where applicable and not in conflict with the MDR. The Note also provides a sample list of sanctions that are considered still applicable.

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