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EU Medical Device Coordination Group (MDCG) approves “Guidance” on the borderline between medical devices and medicinal products in order to support the uniform application of Regulation (EU) 2017/745 (MDR) across the European Union.
19 Apr
Electronic prescriptions: Recent updates
A note published by the Ministry of Health and the Ministry of Economy and Finance on March 3, 2022, announced that as of January 31, 2022, electronic prescriptions for drugs that are not reimbursed by the National Health System are operational in parts of the Italian territory.
19 Apr
MDCG Guidance: Notified bodies and surveillance of legacy devices
On February 16, 2022, the Medical Device Coordination Group (MDCG) established by Article 103 of Regulation (EU) 2017/745 (MDR) published a document providing guidance for appropriate surveillance regarding the transitional provisions under Article 120 of the MDR.
19 Apr
Deblistering: A new frontier for the “pharmacy of services”
The note on “the preparation of personalized packaging to improve therapeutic adherence of patients” released on February 3 by the Regione Lombardia sets a milestone in Italy for deblistering, which could soon become a standard service provided by Italian pharmacies as it already is provided by pharmacies in many other countries around the world.
19 Apr
The new decree on non-profit studies: Data and results may now be sold
On February 16, 2022, more than two years later than planned, the Ministerial Decree of November 30, 2021, containing measures to facilitate and support the development of nonprofit clinical trials of medicinal products and observational studies, as well as to regulate the transfer of data and results of nonprofit trials for registration purposes, was finally published in the Official Gazette.
19 Apr
Import and Distribution of Medical Devices in Switzerland – Amended Rules
The import and distribution of medical devices in Switzerland is governed by the Swiss Therapeutic Products Act and the Swiss Medical Devices Ordinance (MedDO). As of 26 May 2021, MedDO has been revised, foreseeing stricter and additional obligations for the operators active on the Swiss market.
Welcome to the Portolano Cavallo Life Sciences blog focusing on legal development and key legal issues affecting the life sciences and healthcare industry.
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Our highly-ranked team of professionals will provide newsinsights and multidisciplinary commentary on the hottest and most recent regulatory, transactional and contentious aspects of the pharmaceutical, bio-tech, med-tech, food supplement and healthcare world with an eye on its digital transformation and technological developments.

This blog will be a place for focusing on digital health, telemedicine and artificial intelligence, as well as more traditional topics: from the protection of intellectual properties to performance of clinical trials, from the market access to advertising and competition issues, from internal and criminal investigations to M&A and venture capital transactions.

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April 27, 2022
EU Medical Device Coordination Group (MDCG) approves “Guidance” on the borderline between medical devices and medicinal products in order to support the uniform application of Regulation...
April 5, 2022
Electronic prescriptions: the current modalities of transmission from doctors to patients and from patients to pharmacies are extended until 31st December 2022
March 24, 2022
EU Medical Device Coordination Group (MDCG) approves “Guidance” on appropriate surveillance of devices covered by certificates according to the MD Directives, under the transitional prov...
March 21, 2022
Published Decree of Health Ministry identifying the ethics committees of national significance for clinical trials of medicinal products and medical devices
February 23, 2022
Published Decree of Health Ministry providing measures to enhance no-profit clinical trials and to regulate transfers of data and results of no-profit studies for registration purposes
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