The European Commission has introduced a five-year transition period for medical device manufacturers to adapt to new harmonized standards, particularly regarding labeling symbols.
Recently, the Commission revised standards affecting medical devices and diagnostics, specifically EN ISO 15223-1:2021, which dictates the symbols for conveying information on medical devices and their packaging. A key change is the replacement of “EC REP” with “EU REP” to denote “authorized representative.” This transition period acknowledges the substantial time and resources required for manufacturers to update their labeling and distribution processes.
During this five-year window, companies can use either or both symbols on their products, as long as the information regarding the authorized representative is clear. The deadline for fully transitioning to the new symbol is set for June 17, 2031.
In related news, the notified body association Team-NB has raised concerns about proposed fee discounts for small medical device manufacturers, warning that these could destabilize the sector. They argue that the initiative could lead to increased bottlenecks and hinder market access for small companies, despite its intention to support them.
Meanwhile, in the UK, the National AI Commission is preparing to recommend significant regulatory reforms for AI in healthcare, based on extensive consultations. The findings emphasize the need for a risk-based approach to regulation, aiming to enhance patient safety while adapting to the unique challenges posed by AI technologies.
These developments reflect ongoing efforts to refine regulatory frameworks in the life sciences sector, as organizations strive to balance innovation with safety and compliance.