Legislative Decree 137/2022 on medical devices and Legislative Decree 138/2022 on in vitro diagnostics were published in the Italian Official Gazette of 13 September 2022 No. 214. These measures, already approved by the Council of Ministers on 28 July 2022, harmonise Italian law with the new EU Regulations 745/2017 and 746/2017. In other words, they amend and repeal the previous Leg. Decree 46/97 on medical devices, Leg. Decree 507/92 on active implantable devices and Leg. Decree 332/2000 on in vitro diagnostics, introducing a new legislative framework consistent with the new EU regulations. As repeatedly stated, this framework is grounded on the EU Regulations as fundamental texts. But this does not detract from the scope of the new decrees mentioned, which not only create a bridge between the Community and national frameworks, but also regulate aspects that the Regulations themselves 'delegate' to Member States.
Changes to the legislative framework
In addition to the issues already mentioned in our previous articles, there is no doubt that the impact of the decrees is of absolute importance with regard to the penalty regime. Article 113 of the MDR and Article 105 of the IVDR stipulate that it is the Member States that must define the sanctions to be applied in the event of a breach of the MDR and must take all necessary measures to ensure their implementation. These penalties must also be 'effective, proportionate and dissuasive'.
Range of the penalties
On this aspect, the two decrees are considerably full-bodied and detailed. Suffice it to say that the previous Article 23 of Leg. Decree 46/97 on sanctions for medical devices consisted of only ten paragraphs, while Article 27 of the new Leg. Decree 137/2022 contains as many as 54 paragraphs (four pages of sanctions alone!). The quantum of penalties ranges from a minimum of EUR 20,000 to over EUR 150,000. As the Regulations draw a legal framework that is much more complex and articulated than the Directives, similarly the penalty regime appears richer, since both the subjects and the sanctionable cases are much more numerous.
Manufacturers are more exposed
It is evident that the manufacturer is the entity for which the greatest number of sanctionable cases are envisaged (approximately forty). By way of example only, if the manufacturer does not have a quality management system that includes a post-market surveillance system and a system for recording and reporting incidents and safety corrective actions, they may be sanctioned with an amount ranging from EUR 24,200 to EUR 145,000 (Article 27(8) Leg. Decree 137/2022), while the failure to draw up or update the technical documentation or the post-marketing surveillance plan or the post-marketing surveillance reports or the periodic safety update report may result in a sanction ranging from EUR 20,000 to EUR 120,000 (Article 27(7) Leg. Decree 137/2022).
Moreover, if the manufacturer has not set up the financial coverage measures in relation to the type of device and the size of the company (Article 10(16) MDR), the applicable penalty may range from EUR 26,000 to EUR 120,000 and the non-use of the Italian language on the label or in the instructions for use may be sanctioned from EUR 20,000 to EUR 112,000 (Article 6(4) and Article 27 of Leg. Decree 137/2022).
Risks for other entities
In addition to the manufacturer, other economic operators can also be sanctioned. An importer which does not keep the Declaration of Conformity (perhaps because they do not possess it) and, where applicable, the EC Certification of the Notified Body, may be sanctioned with an amount ranging between EUR 20,000 and EUR 120,000. If an importer (or distributor) modifies the label and/or packaging without following the procedure set out in Article 16 MDR, the penalty may range from EUR 11,300 to EUR 113,200.
Sponsors and notification of clinical investigations
In turn, the distributor who does not cooperate with the Competent Authority may be sanctioned with an amount from EUR 24,200 to EUR 145,000, while the sponsor who initiates a clinical investigation and fails to provide the mandatory notification will be sanctioned with an amount from EUR 20,000 to EUR 112,000. Similar amounts are foreseen for failure to register and report adverse events occurring during clinical investigations. Penalties also apply to Notified Bodies should they carry out conformity assessment activities outside the scope of Article 42(3) (MDR), which will be sanctioned with an amount from EUR 24,200 to EUR 145,000.
When is the PRRC not exempt from liability?
The provision of sanctions against the Person Responsible for Regulatory Compliance (PRRC) deserves separate consideration. When the Decrees were being drafted, there was much discussion as to whether or not the Person Responsible should also be subject to penalties. Then the Italian lawmaker decided to make this figure directly responsible as well. Thus, Article 27(17) states that 'the person responsible for regulatory compliance who violates the obligations set out in Article 15(3) of the regulation shall be subject to an administrative sanction ranging from EUR 20,000 to EUR 120,000'. In other words, the PRRC is exposed to a significant penalty if it does not ensure that:
There is no doubt that this choice aims to raise the level of control over the devices through greater accountability of the PRRC; but it is equally evident that those who have taken on this role or intend to take it on will raise demands (including economic ones) to 'cover' for possible sanction enforcement.
Additional things to know
Some final considerations on the modalities of application and calculation of penalties provided for in Article 27 paragraphs 48-54: