Medical Device Legal News with Sam Bernstein: Episode 11
The European Commission (EC) has published draft antitrust guidelines on exclusionary abuses (the Draft Guidelines) and is conducting a public consultation to gather feedback....more
The European Commission has published for public consultation its long-awaited draft Guidelines on exclusionary abuses (draft Guidelines). The draft Guidelines aim at making it faster and easier for the Commission to pursue...more
The Draft Guidelines set out the European Commission (EC)’s approach on exclusionary abuse by dominant undertakings. The EC is proposing a shift away from the effects-based approach set out in its earlier enforcement...more
As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. ...more
As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving...more
Antitrust enforcers remained active across the globe, with the announcement by the FTC and DOJ of proposed guidelines that have an emphasis on tech mergers in the United States, and several investigations of major tech deals...more
In Short - The Development: The European Commission ("EC") has published highly anticipated draft guidelines ("Draft Guidelines") detailing a new antitrust exemption for agreements in the agriculture and food supply chain...more
Specific compliance considerations apply to M&A transactions and public tenders. On 12 January 2023, the Foreign Subsidies Regulation (FSR) entered into force. The FSR empowers the European Commission (Commission) to...more
On February 6, 2023, the European Commission (EC) published a draft Implementing Regulation (the Implementing Regulation) setting out rules and procedures for the application of the Foreign Subsidies Regulation (FSR)....more
Summary and Background - On 11 May 2022, the European Commission (the “Commission”) published its draft proposal for a debt-equity bias reduction allowance (“DEBRA” or, the “Directive”), which forms part of the...more
As part of its review of the EU antitrust rules governing vertical agreements, the European Commission (EC) has published for consultation a draft new section of its Vertical Guidelines, which contains proposed guidance on...more
The European Commission has published a new draft guidance with regard to exchange of information related to dual distribution. This draft guidance provides valuable dos and don’ts for companies concerning the information...more
The European Commission has published draft Guidelines on the application of competition law to collective bargaining involving the working conditions of the “solo self-employed”. The draft Guidelines clarify the Commission’s...more
In follow-up to our colleagues recent post about the newly implemented Medical Device Regulation (“MDR”) in the European Union, this post will discuss some of the similarities between FDA’s Clinical Decision Support (“CDS”)...more
In 2016, European companies doing business in the US were able to breathe a sigh of relief. The European Commission deemed the Privacy Shield to be an adequate privacy protection. For the next half a decade, this shield, as...more
In this month's edition, we examine the European Commission's Digital Services Act and its potential regulatory impact, the National Institute of Standards and Technology's draft guidance on internet-of-things devices'...more
In this month's edition of our Privacy & Cybersecurity Update, we examine Washington state's new facial recognition law, the U.K. Supreme Court's ruling that an employer is not liable for a data breach caused by a disgruntled...more
The European Commission announced on 22 January 2020 that it is looking for feedback on draft guidelines on the implementation of Article 4 of the Market Surveillance Regulation (EU) 2019/1020 (the "Regulation"). ...more
BREXIT! A word that might have been unthinkable a mere two years ago now raises so many questions for today’s trademark professionals – but some of those key questions were recently answered, at least for now. ...more
• European Commission publishes survey on concept of “Specially Designed for Military Use,” and issues request for input for possible EU commercial policy measures targeting the United States • Netherlands introduces...more
UK Tax News and Developments - The OTS publishes its report "Value added tax: routes to simplification" - On 7 November, the Office of Tax Simplification (OTS) published its first report on VAT, which included a range...more
The European Central Bank published for consultation draft Guidance on the fit and proper assessment of members of management bodies of significant banks. The ECB is responsible for direct prudential supervision of certain...more
As part of the Commission’s Digital Single Market initiative, the European Commission has published a draft Regulation aimed at preventing traders from discriminating against customers based on nationality or location. The...more
The European Food Safety Authority (EFSA) has begun a public consultation on its draft guidance on the preparation and presentation of an application for authorization of a novel food. As reported in our December 22, 2015,...more
The European Commission (EC) Standing Committee on Plants, Animals, Food and Feed has issued a guidance document entitled Draft Guidance Document on the Interpretation of the Transitional Measures for the Data Requirements...more