Medical Device - Regulatory

Portable Electronic Devices (PED) include digital cameras, smartphones, tablets, e-readers, etc. The guidance issued by the EU’s Aviation Safety Agency (EASA) refers to all PEDs as long as they are not transmitting. That means they are in Airplane Mode or Flight Mode (here after Flight Mode). Transmissions such as connection to mobile phone network, Wi-Fi, Bluetooth etc. should be switched off.

Portable Medical Devices

Portable medical devices are electronic equipment used for monitoring, operating, and managing medical conditions. These devices are becoming more and more portable, light in weight, and compact due to the advancements in microprocessor technology. The market is segmented by product (diagnostic imaging, monitoring devices, and other products), end user (hospitals, physician offices, home care settings, and other end users), and geography (North America, Europe, Asia-Pacific, Middle East & Africa, and South America). The report also covers the estimated market sizes and trends for 17 countries across major regions globally.

Some examples are:

  • Pulse oximeter
  • Heart monitors
  • Respiratory monitors
  • Cardiac monitors
  • Medical imaging
  • Blood pressure monitors

By Equipment: Respiratory Monitoring, Monitoring Products (Heart/Cardiac Monitors, Pulse Oximeters, Blood Pressure Monitors and Others), Smart-Wearable Devices, Hemodynamic Monitor Devices and others.

By Application: Cardiology, Gastrointestinal, Gynaecology, Neurology, Orthopaedic, Respiratory, Urology and Others.

By End-users: Hospitals, Nursing Homes, Physician Offices, Homecare Patients and Others.

By Geography: North America (the U.S., Canada and Mexico), Europe (Germany, the UK, France, Italy, Spain, Russia and the Rest of Europe), Asia-Pacific (China, Japan India, South Korea, Australia and New Zealand and the Rest of Asia Pacific), South America (Brazil, Argentina, Chile, Colombia and the Rest of South America) and the Rest of the World (the Middle East and Africa).

Portable Non-Medical Devices

In June 2022 the European Union passed the Radio Equipment Directive, which includes a provision colloquially known as the “Common Charger Proposal” that will require newest portable electronic devices sold within the EU to use the USB-C charging port by the Autumn of 2024. The intent according to EU officials is to make products in the EU more sustainable, reduce electronic waste, and make consumer lives easier.

The USB-C will become the standard port for thirteen products that fall within the scope of the new law, eliminating the need for consumers to have different chargers for different devices.

Thirteen products are within the scope of the new law:

  • By Autumn 2024 or early 2025: mobile phones, tablets, e-readers, keyboards, mouse portable navigation systems, portable speakers, headsets, earbuds, earphones, handheld videogame consoles and digital cameras.
  • By 2026: laptop devices

The Requirements under the new law:

  • USB-C charging port: The product categories listed above will need to have a common (USB-C) charger port from the date of application, which is expected to be Autumn 2024 or early 2025 (2026 for laptop devices).
  • Fast charging technology: The charging speed for devices supporting fast charging technology will be harmonized, so that users can charge their devices at the same speed with any compatible charger.
  • Unbundling: Manufacturers will be required to offer consumers the choice of purchasing a new electronic device without a new charger. The question of whether the cable should also be unbundled has been deferred for now.
  • Consumer information: Packaging must include a pictogram specifying whether a new device comes with a charger, and a label indicating the charging performance.
  • Wired Charging Only: The law only applies to charging via a wired cable. The law does not apply to wireless charging.

By the end of 2024, the proliferation of chargers for small electronic devices will come to an end. The EU is making USB-C connectors and the USB Power Delivery standards mandatory.

From 28 December 2024, all mobile phones, tablets and cameras sold in the EU must have a USB-C charging port. This will also apply to laptops from spring 2026. The EU wants to reduce electronic waste and make electrical appliances more sustainable.

The European Parliament had already adopted this in October 2023 as an amendment to the Radio Equipment Directive and then passed it on to the member states for implementation into national law.

For further information regarding the Portable Electronic Devices Change Requirements under the new legislation in the European Union, please reach out to our team of experts at MakroCare.

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