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Portolano Cavallo Life Sciences Blog  / European Commission
5 Dec 22
The European Commission sends a Statement of Objection to a drug manufacturer accusing it of regulatory gaming and denigration of competitors in breach of Article 102 TFEU
On October 10, 2022, the European Commission sent a Statement of Objection to Teva accusing the company of denigrating a competing product and of “regulatory gaming” in management of the life cycle of its multiple sclerosis drug Capoxone, conduct deemed abusive pursuant to Article 102 of the Treaty on the Functioning of the European Union.
7 Feb 22
Digitization of Instructions for Use: the European Commission has endorsed a new Implementing Regulation on the use of electronic instructions for use (eIFUs) of medical devices
On December 14 2021, the European Commission adopted a new Implementing Regulation (EU) 2021/2226 laying down rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council relating to electronic instructions for use of medical devices.
4 Feb 22
IVD devices: Extension of timelines for the application of Regulation (EU) 2017/746
Regulation (EU) 2022/112 of the European Parliament and of the Council amending Regulation (EU) 2017/746 as regards transitional provisions for certain in vitro diagnostic medical devices and the deferred application of conditions for in-house devices was published on January 25, 2022.
The European Commission’s Medical Device Coordination Group (MDCG) endorsed a new guidance on the operational and practical implementation of Articles 13&14 and other related obligations for importers and distributors under MDR and IVDR Regulations
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The European Commission’s Medical Device Coordination Group (MDCG) endorsed a new guidance on the classification of medical devices
EU pharmaceutical strategy: today the Commission launched a public consultation on the revision of the EU general pharmaceuticals legislation (open until December 21, 2021)
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 news, insights 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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March 20, 2023
Today, Regulation (EU) 2023/607 extending the transitional provisions for the placing on the market and putting into service of certain medical devices and in vitro diagnostic medical device...
January 31, 2023
Clinical trials: Ministry of Health signed off on decrees that (i) reorganize ethics committees and coordinate their activities, (ii) determine the single tariff for the authorization proced...
December 19, 2022
On 13 December 2022, EMA, European Commission and HMA jointly adopted a recommendation paper on the introduction of decentralised elements in the conduct of Clinical Trials in the EU/EEA
September 21, 2022
Payback for medical devices: Decree quantifying the exceeding of the expenditure ceiling for medical devices at national and regional level for the years 2015, 2016, 2017 and 2018 published ...
September 1, 2022
The 2021 annual law for market and competition addressing, as to the healthcare sector, reimbursement of drugs, intermediate distribution, patent linkage and institutional accreditation of p...
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