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Italy issues new rules on medical device vigilance

Published by Isabella Greenock, Medical Device Paralegal on

Two new decrees (Decree no. 137 and no. 138 of 5th August 2022) have recently entered into force in Italy, bringing the national regulatory framework for medical devices into closer alignment with the EU MDR and IVDR. The decrees update the existing framework in a number of areas, notably in relation to post-market surveillance and vigilance. This marks an important step forward in ensuring a higher level of safety of medical devices within Italy.

Designation of a competent authority 

The decrees designate the Italian Ministry of Health as the national competent authority responsible for the regulatory and administrative functions of the EU Regulations. This means the Ministry is the body tasked with overseeing surveillance activities and receiving incident reports. Upon receipt of a report, the Ministry must evaluate the information regarding the incident and monitor any corrective actions taken by the manufacturer.

In addition to these surveillance and vigilance activities, the Ministry of Health is assigned the following duties under the decrees: 

  • Designating and monitoring Italian notified bodies - Italy currently has nine Notified Bodies designated under the EU MDR (the most out of any EU Member State). As national competent authorities continue to designate more notified bodies to ensure sufficient capacity, it is likely the Ministry of Health will be very busy.
  • Authorising the sale of devices which have not yet gone through the full conformity assessment process in exceptional cases of necessity and urgency and in the interests of public health or patient safety
  • Verifying information entered by manufacturers on Eudamed, the EU medical device database

Strengthening of incident reporting requirements

The decrees supplement the requirements of the EU Regulations on the reporting of adverse incidents occurring after devices have been placed on the market. Under the EU Regulations, manufacturers have an obligation to report to the competent authority any serious incidents[1] occurring through use of their devices. In addition, manufacturers are required to report any significant variations in the frequency/severity of non-serious incidents. However, under the EU regulations, healthcare professionals, users and patients are only ‘encouraged’ to report serious events.

The decrees go a step further in this respect by creating a concrete obligation for healthcare professionals to report both serious incidents and any complaints concerning devices. The new obligations are similar with the provisions of the national regulations which were in force prior to the decrees. However, the obligation now requires healthcare professionals (whether public or private) to report to both the Italian Ministry of Health as the competent authority, as well as to the manufacturer of the relevant device. The decrees also allows healthcare professionals, users and patients to report non-serious incidents. In implementing and strengthening the post-market vigilance requirements of the EU Regulations, Italy has taken important steps towards developing procedures for maintaining a high level of safety in relation to medical devices.

What’s next for Italy’s vigilance system?

The decrees mark a significant step in progress in the alignment of Italy’s national framework with the EU medical device regulations. However, there is still much that needs to be done. In particular, further implementing measures will likely need to be adopted to clearly establish the modalities for reporting serious incidents involving medical devices. More clarity in this respect would help manufacturers in adapting their internal processes and procedures to ensure compliance with the new vigilance obligations (including responding to reports made by healthcare professionals). We are keeping a close eye on these developments, so subscribe to our newsletter to stay up to date!

 

[1] Defined in the Regulations as any incident (directly or indirectly) leading to:

  1. the death of a patient, user or any other person,
  2. the serious deterioration of a patient, user or any other person's state of health, or
  3. a serious public health threat.