On 9 December 2021, the Medical Device Coordination Group published a question and answers document concerning obligations applicable to importers and distributors under Articles 13 and 14 of Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices.
On 25 November 2021, the European Commission adopted Implementing Regulation (EU) 2021/2071 subjecting vaccines against COVID-19 and active substances used for the manufacture of same to export surveillance for a period of 24 months starting from 1 January. This Regulation will replace the existing regulatory framework requiring vaccine exports to be subject to an authorization by Member States.
Pending the full functionality of the European Database on Medical Devices, the European Commission made available two new modules, to be used on a voluntary basis, for the registration of medical devices by economic operators and for the registration of certificates of conformity by notified bodies.
On 29 November 2021, Legislative Decree No. 179/2021 was published in the Official Journal, introducing the applicable sanctions for violations of Regulation (EU) No. 528/2012 concerning the making available on the market and use of biocidal products. The new sanctions entered into force on 14 December 2021.
On 4 November 2021, the Council of Ministers approved the Competition Bill for 2021 (“Competition Bill”), to be submitted to the Parliament for its examination. The provisions of the Competition Bill affect various sectors, including the healthcare one. In this regard, the most important innovations are those concerning (i) medicines for which the pricing and reimbursement procedure is still pending; (ii) the reimbursement of generic drugs; (iii) the distribution of medicines; and (iv) the production of blood-derivative drugs.
On October 21, 2021, the MDCG published a new question and answer document on the procedures governing the relabeling and repackaging of medical devices under Article 16 of the MDR and IVMDR.
On November 25, 2021, the AIFA published two new simplified negotiation procedures for (i) the negotiation of generic or biosimilar drugs and reimbursement applications for the extension of indications already reimbursed for the originator, and (ii) the reimbursement of new packages for changes in the primary packaging.
On 27 November 2021, Law No. 175/2021 (“Consolidated Law”) was published in the Official Journal. The Consolidated Law’s main objective is the protection of the right to health of those suffering from rare diseases through measures aimed at ensuring the uniform distribution of services and medicines, including orphan drugs, throughout the Italian territory, the surveillance, diagnosis and treatment of rare diseases as well as the support to research activities.
In October 2021, the Medical Device Coordination Group (MDCG) published the third revision of the MDCG 2019-6 Questions and answers: Requirements relating to notified bodies, which provides clarification on the operating procedures of notified bodies responsible for performing conformity assessment activities under Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices.
On November 17, 2021, the Ministry of Health published a circular letter to clarify certain aspects related to the application of Regulation 2017/745 on medical devices, including those concerning the registration in the national database of medical devices, custom-made devices, and medical device advertising.