In September 2022, the Borderline and Classification Working Group, a subgroup of the Medical Device Coordination Group (MDCG), issued a manual to determine whether a particular product qualifies as a medical device or in vitro diagnostic and into which class a particular medical device or in vitro diagnostic falls. The MDCG is operating under the Medical Device Regulation and the In Vitro Diagnostic Medical Device Regulation.
Switzerland is substantially revising and modernizing its insurance supervision laws, i.e., the federal law on the supervision of insurance carriers (Versicherungsaufsichtsgesetz) and the respective ordinance (Versicherungsaufsichtsverordnung). The new law is expected to come into effect on 1 July 2023 or 1 January 2024. It will introduce a new, risk-based supervision regime that allows for more tailor-made supervision.
This event will take place at the Zürich Marriott Hotel on 31 October 2022 from 1:30pm to 5:00pm. Please note that this event will be held in German only.
The European Whistleblowing Directive was to be implemented by the European Union’s 27 member states by no later than 17 December 2021, impacting employers with operations in those jurisdictions. Member states are still passing their implementing legislation, meaning employers are facing a period of intense activity as they adapt to changes in legislation across the region.
On 19 September 2022, the European Commission adopted a proposal that would give the EU sweeping new powers to address shortages and supply chain disruptions of crisis-relevant and strategic goods and services in times of crisis. The proposed Single Market Emergency Instrument (SMEI) is the latest in a series of EU measures that will impact supply chains, including new proposals for rules on foreign subsidies, corporate sustainability reporting and due diligence, carbon taxes, deforestation, and, most recently, a proposal to prohibit products made with forced labor from the EU internal market. Once adopted, the SMEI will impose far-reaching obligations on EU firms.
The Constitutional Court in South Africa recently clarified the application of the doctrine of common purpose in the employment law context. The Constitutional Court answered the question as to whether an employer may apply the doctrine of common purpose to dismiss employees for misconduct where the employees were spectators to a violent assault during an unprotected strike. This decision has implications for employers who intend to dismiss employees for these reasons.
On 15 September 2022, Deputy Attorney General Lisa Monaco issued a memorandum to Department of Justice prosecutors entitled “Further Revisions to Corporate Criminal Enforcement Policies Following Discussions with Corporate Crime Advisory Group”. As has become common in recent years (with a brief intermission under Deputy Attorney General Rod Rosenstein who objected to the practice), such memoranda and other Department pronouncements have come to herald key developments in DOJ policy on corporate criminal enforcement and related practice. These memoranda are therefore closely watched by the defense bar and corporate counsel alike.
In 2020, MyCC imposed a total financial penalty of RM173 million against the General Insurance Association of Malaysia (PIAM) and its 23 members for alleged price-fixing of trade discounts on automotive parts prices and hourly labour rates for motor vehicle repairs by workshops under the PIAM Approved Repairers Scheme in breach of the Competition Act 2010. PIAM and the general insurers appealed to the Competition Appeal Tribunal (CAT). In September 2022, the CAT found that there was no liability on the part of the general insurers and PIAM under the Malaysian Competition Act and unanimously overturned MyCC’s decision.
In August 2022, the French Agency for the Safety of Health Products published an updated version of its guidelines for determining financial penalties, which will come into effect on 1 October 2022.
The Spanish Ministry for Health, Consumer Affairs and Social Welfare have published the Draft of the Reference Price Order of 2022 with the aim of updating the reference prices set forth in previous orders, establishing new groups and removing those that do not meet the applicable requirements.