January 13, 2026
The reconfirmation of ISO 13485:2016 provides stability and supports better planning of quality strategies. Medical device manufacturers in Europe can use this advantage to focus resources on MDR implementation and ongoing compliance.
Fill out the DIN EN ISO 13485 questionnaire now
Following its most recent systematic review, ISO 13485:2016 has been officially reconfirmed and will remain valid without revision until April 2030. This decision confirms that the internationally recognized standard for quality management systems for medical devices will continue to apply unchanged for the coming years.
At a time of increasing regulatory complexity, particularly due to MDR requirements such as technical documentation updates, PMS and PMCF activities, and enhanced clinical requirements, the reconfirmation of ISO 13485 provides a strategic planning advantage for manufacturers.
Manufacturers can continue to rely on a stable quality management system (QMS) foundation while directing important resources toward MDR-related obligations, without the need for additional changes resulting from a revised ISO 13485 standard.
TÜV NORD is an internationally recognized testing and certification service provider. We assess and certify the fulfilment of legal requirements and voluntary standards worldwide. Our auditors are experts in their field and work with a standardized methodology. This allows us to guarantee you neutrality, independence and continuous support.
The details and information on the reconfirmed ISO 13485 standard were made available following an evaluation by Dr. Fulya Özmen from TÜV NORD Turkey.