The European Union’s new Medical Device Regulation (MDR) is set to be fully implemented by the end of 2028. At present, only 16 Taiwanese manufacturers—including Qisda, AmCad BioMed, PACIFIC HOSPITAL SUPPLY, United Orthopedic, Avita, Wellell, and Visco Vision—have successfully obtained MDR certification, securing their entry into the EU market. Older certificates issued under the former MDD framework for invasive, moderate- to high-risk devices expired at the end of last year, posing a major challenge for companies seeking to maintain or expand their European market presence.
The MDR was announced in May 2017 with an original plan to replace MDD entirely by 2021, followed by a transition period through 2024. However, due to a shortage of notified bodies and growing industry pressure, the number of successful MDR certifications has been limited, raising concerns about a potential shortage of compliant medical devices in Europe. In response, the EU proposed an emergency extension of the transition period, granting phased extensions for legacy certificates based on product risk classifications.
It has now been confirmed that the MDR will be fully enforced by the end of 2028. Certificates for high-risk Class III and implantable Class IIb devices expired at the end of last year. Moving forward, Taiwanese manufacturers will need MDR certification to gain entry into the EU market.
Li Yung-Chuan, Chairman of the Taiwan Medical and Biotech Industry Association (TMBIA), noted that while the MDR presents challenges, it also offers a crucial opportunity for Taiwan’s medical device sector to upgrade and expand internationally. The association is actively promoting support programs to help local companies strengthen their global competitiveness.
According to TMBIA, the 16 Taiwanese companies that have obtained MDR certification include Qisda, AmCad BioMed, United Orthopedic, PACIFIC HOSPITAL SUPPLY, Wellell, LAGIS Enterprise, Avita, Radiant Innovation, Visco Vision, UNICON OPTICAL, Yung Sheng Optical, STURDY INDUSTRIAL, CARILEX MEDICAL, Charder Electronic, Galemed, and SHL Medical Taiwan.
TMBIA’s Regulatory and Clinical Affairs Director, Chiu Tzu-Hsun, explained that Taiwanese exports to the EU account for about 15% of total medical device exports, with Germany, the UK, the Netherlands, and Italy collectively comprising around 12%. As of now, 385 Taiwanese medical device companies—including Class I device manufacturers—are registered to sell in the EU. With MDR implementation underway, the number of certified companies is expected to continue rising.
Li further emphasized that MDR is not merely a compliance requirement, but a shift in regulatory philosophy. It underscores patient safety, data transparency, and full lifecycle traceability of medical devices. For manufacturers, obtaining MDR certification is a critical threshold for entering the European market, requiring robust implementation of risk assessments, quality management systems, and post-market surveillance aligned with stringent regulatory expectations.
Resource: 歐盟MDR 2028上路！佳世達、聯合等16家台廠先拿到門票
