Gaspare Castelli

Gaspare Castelli collaborates with the Stefanelli&Stefanelli Law Firm in the areas of company law and medical devices.

His previous professional experience has led him to specialize in the field of civil law, in particular banking law and in disputes relating to financial products.

He has acquired experience in debt collection, real estate and securities enforcement procedures and over-indebtedness procedures.

He obtained his diploma as a specialist in the legal professions at the School of Specialization for the Legal Professions "Enrico Redenti" in Bologna.

Recent Publications


Electronic instructions for use of medical devices: here’s what you need to know

The year 2022 opens with the new (long-awaited) EU Regulation 2021/2226 on electronic instructions for use (IFU) for medical devices. The Regulation, which entered into force on 4 January 2022, replaces the previous EU Reg. no. 207/2012 and aims to adapt the rules for electronic IFUs to the new EU Regulation 2017/745 (MDR), to technological developments of recent years and to the principles of the Green Economy. In particular, EU Regulation 2021/2226 has an impact on the field of medical software: for the first time it is regulating the rules for electronic instructions for use for “Software as medical devices” (SaMD), such as apps.

The market release notion and its significance post-Brexit

As is well-known, the much-awaited agreement between the European Union and the United Kingdom was reached on Christmas Eve. Whilst it regulated all goods passing through the customs border between the European Union and the United Kingdom in detail (it will thus be of fundamental importance to determine whether a product is European and/or British in origin), nothing further emerged regarding the UK's regulations regarding CE marked products.