Review of Recent Legislative Acts
Commission Delegated Regulation (EU) 2026/1451
This act amends the Medical Devices Regulation (EU) 2017/745 to update the specific list of implantable and Class III medical devices. It explicitly defines which of these high-risk devices are exempted from the general legal requirement to conduct formal clinical investigations, provided they meet predefined safety and performance equivalence criteria.
Commission Delegated Regulation (EU) 2026/1359
This regulation updates the compliance framework for Class IIb implantable medical devices. It modifies the existing list of devices exempted from the requirement to undergo an individual assessment of technical documentation for every single device. This change allows for more streamlined administrative compliance for specific categories of devices that have demonstrated consistent safety profiles.
Commission Implementing Regulation (EU) 2026/1412
This regulation sets the updated benchmark values for the free allocation of emission allowances under the EU Emissions Trading System (ETS) for the 2026–2030 period. These values dictate the quantity of greenhouse gas emission permits provided free of charge to industrial installations to prevent “carbon leakage,” based on the performance of the most efficient installations in the Union.
Commission Implementing Regulation (EU) 2026/1406
This act revises the sanitary survey requirements for the classification and monitoring of production and relaying areas for live bivalve molluscs (such as oysters and mussels). It adjusts the methodology and frequency of environmental and microbiological monitoring required to ensure that harvesting areas remain safe for human consumption and free from contamination.
UN Regulation No. 166 [2026/1365]
This international regulation establishes uniform technical standards for motor vehicles regarding the driver’s awareness of vulnerable road users (pedestrians, cyclists, etc.) located in the immediate front and lateral proximity of the vehicle. It mandates the integration of detection systems designed to mitigate blind-spot risks and enhance safety in close-proximity maneuvers.
