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Riccardo Ovidi

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Riccardo Ovidi is an Associate in Baker McKenzie Rome office.

With Decree dated 29 April 2022, published in the Official Gazette on 24 May 2022, the Ministry of Health approved the organizational guidelines on the “Digital model for the implementation of home-care”. The guidelines set out a reference model for the implementation of various telemedicine services in the home-care setting, through the identification of innovative processes for taking care of patients at home and the enhancement of multi-professional and multidisciplinary collaboration between the various professionals.

On 31 May 2022, the National Coordination Centre of Ethics Committees updated the templates for the conduct of clinical trials on medicinal products and clinical investigations on medical devices that identify the minimum content of the agreement between sponsors/CROs and clinical sites to ensure the uniformity of administrative, economic and insurance aspects.

With judgment No. 705 of 21 May 2022, the Administrative Court of the Tuscany Region upheld the complaint against the decision to award a tender for a framework agreement for the supply of coronary stents to the regional health service, under which tenderers were required to offer the “most recently marketed” device. In his regard, the plaintiff complained that the successful tenderer offered a product that was on the market for years, although the same product was in line with the technical requirements set out in the tender specifications.

With Judgment No. 544 of 18 July 2022, the Administrative Court of the Basilicata Region dismissed the appeal against the decision to award a tender for the supply of flu vaccines to the regional health service. In this regard, the plaintiff challenged the allocation of the type and quantity of flu vaccines to be supplied into separate lots, based on the alleged violation of the principles of competition and non-discrimination.

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.

From 26 May 2022, Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) has applied.
• The main changes introduced by the IVDR include (i) a new classification of devices, (ii) new conformity assessment procedures that differ according to the risk class and the specific characteristics of the device, (iii) reinforced requirements relating to clinical evidence aimed at demonstrating compliance with the safety and performance requirements of the device, (iv) the introduction of post-marketing follow-up obligations for manufacturers aimed at updating the performance evaluation throughout the life cycle of the device, (v) the provision of new obligations for manufacturers, authorized representatives, importers and distributors, and (vi) the obligation for manufacturers to appoint a person responsible for regulatory compliance.