ISO 13485 Update 2025 — Current Status of the Standard

ISO conducts a systematic review every five years to determine whether a standard should be revised, confirmed, or withdrawn. For ISO 13485:2016, the second five-year review cycle began on 15 January 2025. Throughout this review, ISO/TC 210 gathered input from global industry experts, certification bodies and regulatory authorities. The review was officially closed on 5 June 2025.

After analysing the feedback, the committee concluded that ISO 13485:2016 remains fully relevant and continues to meet current industry and regulatory expectations, meaning no changes or amendments are required. According to the ISO official website, the formal announcement confirming the decision was published on 31 October 2025.

One of the key reasons for maintaining the current edition is the need for stability across the medical device industry. ISO 13485 is widely referenced in major regulatory frameworks, including the Medical Device Single Audit Program (MDSAP). Many regulators still rely on the 2016 version, and introducing a revision now could create unnecessary transition challenges and disrupt compliance activities globally.

For organisations certified to ISO 13485, this confirmation means that existing certifications remain valid, and there are no transition or re-certification requirements. Certification bodies will continue to audit against ISO 13485:2016, allowing companies to maintain focus on continuous improvement, risk management and operational efficiency without preparing for a new standard.

Manufacturers are encouraged to continue monitoring updates from ISO/TC 210, as the committee may publish supplementary guidance or future development plans. It is equally important to stay updated with regulatory authority announcements, which may evolve independently from ISO’s review cycle.

Although no revision has been issued, organisations should continue strengthening critical areas such as risk-based decision-making, supplier management, software lifecycle controls, operational process control and documentation practices, as these continue to be essential compliance expectations.

In summary, ISO 13485:2016 remains the current and unchanged standard, following the committee’s decision confirmed on 31 Oct 2025. Medical device manufacturers can continue operating with confidence under the existing requirements while remaining attentive to future developments from ISO and global regulators.