The Medical Device Coordination Group (MDCG), the expert panel of the EU Member States and the EU Commission, has released on 20 October 2021 two guidance documents which provide meaningful guidance (1) for manufacturers, importers and distributors of “legacy devices” on which MDR obligations they must comply with (guidance document 2021-25), and (2) on the obligations of parallel importers regarding the repackaging and relabeling of medical devices under Article 16 MDR/IVDR (guidance document 2021-26).
The growth of digital engagement practices has raised regulatory issues for broker-dealers and investment advisers. In this preview of an article from an upcoming issue of The Review of Securities & Commodities Regulation, Amy Greer discussed a variety of such issues, including account opening due diligence and best execution. They suggest that, as a starting place, to prepare for regulatory examinations firms should review current practices and address those concerns raised by the SEC and FINRA in their recent statements, guidance, and regulatory responses.
On 14 October 2021, the Office of Financial Sanctions Implementation (“OFSI“) published its Annual Review, providing an overview of OFSI’s activities in the financial year April 2020 to March 2021. In 2020-2021, OFSI considered 132 reports of potential financial sanctions breaches, a slight decrease from 140 in 2019-2020. However, the number of cases considered generally remains on an upwards trajectory from the 99 potential financial sanctions breaches considered in 2018 to 2019.
On 25 September 2021, the government passed Decree No. 85/2021/ND-CP amending several provisions of Decree No. 52/20213/ND-CP on e-commerce. The amendments and supplements under Decree No. 85, effective on 1 January 2022, focus on the provision of cross-border e-commerce services in Vietnam.
The European Whistleblowing Directive is to be implemented by the European Union’s 27 member states by no later than 17 December 2021 and will impact employers with operations in those jurisdictions. With most of the Member States yet to pass their implementing legislation, employers will face a period of intense activity in the coming months.
This week’s discussion will cover the following:
• Tether Holdings CFTC Crypto Settlement: Reminder that the CFTC is asserting a prominent role in the regulation and enforcement of cryptocurrencies.
• SEC Report on January 2021 Market Frenzy: “Staff Report on Equity and Options Market Structure Conditions in Early 2021”
• Will DOJ Prosecute Steve Bannon for Contempt?
The law of 21 July 2021, effective as of 31 July 2021, has implemented the European prudential regime applicable to investment firms authorized under the Markets in Financial Instruments Directive II set out under the Investment Firms Directive and the Investment Firms Regulation into Luxembourg law.
Last June, the Superior Court of Justice of the Basque Country delivered a decision with wide repercussion with regards to advertising of medicinal products by pharmaceutical companies. The decision ruled on an appeal filed by Farmaindustria (the Spanish trade association bringing together innovative pharmaceutical companies) against a regional Order regulating the advertising of pharmaceutical products through medical sales representatives in the context of the Basque Health System.
Key developments reflected in this week’s update to the tracker include the following: Colorado, Connecticut, Indiana, Iowa, Louisiana, New Mexico, Rhode Island, Tennessee and Washington, DC extend their state-wide orders and reopening plans. New Mexico issued a new mask mandate requiring all persons aged two or older to wear a mask indoors, except when eating or drinking.
Deals involving SPACs have drawn much attention in recent years due to numerous advantages, including the availability of already-raised capital and a quicker timeline than the standard IPO process. In conjunction with ACC Southern California Chapter, Baker McKenzie partners, Derek Liu, Perrie Weiner, Michelle Heisner and Steve Canner give a primer on de-SPAC transactions as a pathway for private companies to access the public markets, discuss current market trends and some of the regulatory and litigation risks associated with this deal structure.