TÜV NORD Taiwan Seminar- New Era of Regulatory: Safety Innovation and Compliance Challenges for Machinery and Medical Assistive Devices

This seminar focused on the latest compliance developments for medical devices and machinery in the EU market, providing participants with a systematic understanding of relevant regulatory frameworks and key application points.

The first half of the seminar centered on electric wheelchairs and mobility scooters, explaining the regulatory requirements and key safety tests necessary for entering the EU market. The second half analyzed the upcoming new Machinery Regulation, covering topics such as manufacturer responsibilities, functional safety, and issues related to AI and cybersecurity. It also introduced the roles of international standards such as EN ISO 13849-1 and IEC 62443 within the overall compliance framework, helping participants understand future regulatory trends from multiple perspectives.

We thank all participants for their engagement and exchange, which contributed to the success of the seminar and promoted further discussion on these important topics.