Commission Implementing Decision (EU) 2021/2273 specifically updates harmonized standards originally detailed in Annex I and Annex II of Commission Implementing Decision (EU) 2019/1956. Compliance with the requirements of applicable harmonized standards in (EU) 2019/1956 confers a presumption of conformity with RED requirements.
New harmonized standards addressed in the update cover a variety of electrical and electronic products, including laser products, adjustable speed electrical power drive systems, power electronic converter systems and equipment, luminaires, low-voltage switchgear and control gear, uninterruptable power systems (UPS), and certain other electrical equipment designed for use within certain voltage limits.
Those are the findings of a recent study by researchers at the IoT Inspector platform and German IT magazine CHIP, who found a total of 226 potential WiFi security vulnerabilities in routers manufactured by nine companies, including Asus, D-Link, Netgear, and Linksys. Individual routers with the largest number of identified individual vulnerabilities were the TP‑Link Archer AX6000 with 32 vulnerabilities and the Synology RT-2600ac router with 30 vulnerabilities.
A summary of the results of the study was published in early December in an article on the TechTimes website. The TechTimes article also notes that the single biggest action that users can take to protect their routers from cyberattacks is to change the router’s settings to allow automatic updates.
Commission Implementing Regulation (EU) 2021/2226 represents a detailed, article-by-article supplement to the MDD on the conditions under which instructions for the use of medical devices may be provided in electronic form. The Regulation will help expand the use of non-paper-based instructions that can contribute to reduced environmental impact while also lowering manufacturers’ costs.
At the same time, however, the Regulation clearly notes that providing instructions on the use of medical devices in electronic form “should be limited to certain medical devices and accessories intended to be used under specific conditions,” and that “for reasons of safety and efficiency, users should always have the possibility to obtain those instructions for use in paper form upon request.”
The paper, “3D Printing Medical Devices at the Point of Care (PoC),” provides extensive background on the FDA’s current regulation of devices and 3D printing technologies, as well as key challenges to device safety and effectiveness presented by the use of such technologies. The paper also poses 16 different questions on the 3D printing of medical devices to garner input from the medical device industry, healthcare facilities and providers, and other stakeholders.
The FDA says that stakeholder input will “help build the foundation for an appropriate regulatory approach for 3D printing at the point of care, personalized care for patients and new innovations in this area.”
According to an Order, the company, uAvionix, marketed some of its aviation devices to government contractors in the U.S. prior to receiving FCC equipment authorization for those devices. FCC rules require manufacturers of radio transmitters and other electronic devices that emit radiofrequency radiation to obtain the requisite authorization prior to marketing those devices to minimize the risk of interference with authorized communications.
As part of the settlement, uAvionix has admitted that it violated the Commission’s rules and will pay a $13,000 civil penalty. The company has also agreed to implement a compliance plan to prevent future such rule violations.
The companies, CenturyLink, Intrado Safety Communications, Cellco Partnership (d/b/a Verizon Wireless), and AT&T Mobility, have agreed to pay a total of nearly $6.3 million in financial penalties for their roles in four separate 911 outages in September 2020. The outages ranged in length from one to three hours and affected users in multiple states across the U.S.
Commission rules require that “all telecommunications carriers shall transmit all 911 calls to a PSAP (public safety answering point), to a designated statewide default answering point, or to an appropriate local emergency authority.” Carriers are also required to notify designated parties at the affected PSAP “as soon as possible but no later than thirty minutes after discovering the outage.”
In addition to paying the designated financial penalties, each company also agreed to implement a compliance plan to ensure future compliance with FCC rules and to appoint a compliance officer to monitor the plan’s implementation and effectiveness.
The report offers insight into trends related to informal consumer complaints regarding robocalls that were received by the Commission over five full calendar years, from 2016-2020, as well as complaint data and information about enforcement actions through November 2021.
Informal consumer complaints increased dramatically during the first three years covered by the report, from just under 180,000 in 2016 to more than 330,000 in 2018. Total consumer complaints then dropped significantly in the following two-year period, with 271,000 complaints filed in 2019 and just over 212,000 in 2020. However, the first 11 months of 2021 indicate a slight increase over 2020 levels, with more than 214,000 complaints submitted during the period.
The FCC’s Enforcement Bureau has significantly stepped-up actions against robocall operators in recent years. The Commission issued two Notices of Apparent Liability for Forfeiture during 2020, with proposed forfeitures totaling nearly $250 million. The proposed forfeiture amounts included a record $225 million fine against two men reportedly responsible for making approximately one billion spoofed robocalls during the first half of 2019. During the first 11 months of 2021, the Commission issued only one Notice of Apparent Liability for Forfeiture, proposing a $5 million fine.
According to a report posted to the website of CBS News, the suit was filed in December by the Attorney General’s Office in conjunction with district attorneys in 12 California counties and the California Department of Toxic Substances. It alleges that Walmart illegally disposes of nearly 80 tons of hazardous waste each year, an estimate reportedly based on 58 separate inspections conducted by the state of trash compactors at Walmart stores throughout California between 2015 and 2021.
A spokesperson for the company contends that the lawsuit represents an effort by the Attorney General’s office to force the retailer into a new settlement in connection with a 2010 investigation involving similar charges.