The EU’s “Blue Guide on the implementation of the product rules 2022” provides a detailed explanation of current regulations applicable to toys, measuring instruments, radio equipment, low voltage electrical equipment, medical devices, and other types of products. The Blue Guide offers readers explanations and non-binding advice on navigating the EU’s conformity assessment systems, CE marking requirements, and market surveillance activities.
The Blue Guide was originally published in 2000 and was most recently updated in 2016. According to a Commission press release, the current revision represents “a substantial update” to prior editions, addressing the specifics of the EU’s Market Surveillance Regulation (2019/1020) and expanding on information not previously available.
According to a posting on the FDA’s website, the updated Customer Collaboration Portal went live in mid-July and now allows medical device manufacturers to upload medical device submission files for 510(k) and De Novo applications in both eSTAR and eCOPY formats. This eliminates the need for device manufacturers to create and mail compact discs or flash drives to the FDA.
Once files have been uploaded, a manufacturer’s designated “Official Correspondent” can then access the Portal to track the progress of their submission.
The updated Customer Collaboration Portal is in its trial phase, and the FDA is actively soliciting feedback on its use from submitters.
The new standard includes more supplementary tests for certain AV products, including power supplies. As such, the standard’s release is expected to impact manufacturers of devices that have previously received China Compulsory Certification (CCC).
In one day, the FCC’s Region One Enforcement Bureau issued five separate notices to individuals linked to illegal pirate radio broadcasting in the greater New York metro area. Each of the recipients was notified of their potential liability for financial penalties of up to $2 million for continuing their illegal broadcasting operations and instructed to confirm with the FCC that such broadcasting activities had ceased.
The WEF findings were reported in their article, “Top 25 recycling facts and statistics for 2022,” posted on the WTF website. Unfortunately, the news is not good!
Here is a brief summary of the “lowlights” of their report:
- The world produces about 400 million tons of plastic waste a year, but we’re recycling plastic at lower than previously estimated rates. In the U.S., in 2021, we recycled just 2 million tons of the estimated 40 million tons of plastic waste generated, about 5-6% of the total.
- Electronic waste (e-waste) is the fastest-growing source of waste globally. E-waste volumes increased to 53.6 million tons in 2019, an estimated 21% increase in just five years. Yet, only about 17% of discarded e-waste was recycled in 2019.
- The rate of E-waste recycling in the U.S. is trending even lower than global efforts. Only about 15% of the estimated 5 million tons of e-waste discarded here in 2019 was recycled.
- The largest category of waste reported is related to chronic food misallocation and inefficiency. The WEF reports that 40% of the food produced globally is wasted, enough to feed every unnourished person in the world four times over. Further, food waste generates around 10% of global greenhouse gas emissions.
On the plus side, the WEF reports that aluminum and paper recycling efforts have gained the most traction in recent years. Currently, aluminum accounts for only 1% of the U.S. waste stream, despite steady growth in the demand for and consumption of the material. And paper and paper products such as corrugated cardboard achieved a 68% recycling rate in 2021.