In brief
On 5 May 2022, the Council of Ministers preliminarily approved the bill to adapt the Italian legislation to the provisions of Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices. The bills are currently being examined by the competent committees of the Italian Parliament.
Key takeaways
- Although several provisions contained in the bills require the adoption of implementing decrees, it is worth mentioning that both bills provide for several changes, including those introducing the obligation for distributors of medical devices to register in the national database. Such an obligation continues to apply to manufacturers of medical devices, whereas manufacturers of custom-made devices are still required to notify the Ministry of Health of their identification data and the list of products made available in the Italian market.
- Another interesting change is that, in exceptional cases of necessity and urgency, distributors can request from the Ministry of Health a temporary marketing authorization for medical devices which have not yet completed a conformity assessment procedure pursuant to EU Regulations and whose use is in the interest of public health and safety.
- The bills also confirm the need to obtain prior authorization from the Ministry of Health to advertise medicinal devices to the public and the prohibition on advertising custom-made medical devices, prescription medical devices and those that require the assistance of a physician or other health professional to be used. The bills also confirm the requirement for sponsors of clinical investigations to notify the Ministry of Health or to obtain its authorization when starting an investigation, depending on the risk class of the relevant devices.
- Lastly, the bills introduce administrative pecuniary penalties for both violations of the provisions of the EU Regulations and those contained in the same decrees.
