DIO (039840.KQ), a digital implant specialist, stated Wednesday it has obtained European Union Medical Device Regulation (CE MDR) certification for its entire lineup of implant surgical solutions. Following earlier certification for all its implant system product lines, the company has now expanded the scope to include surgical solutions, meeting Europe’s strengthened regulatory standards across its full product portfolio.
MDR certification is a mandatory requirement for selling medical devices in Europe and is regarded as a key indicator verifying product safety and quality in global markets. In major emerging markets across Asia, the Middle East and Africa, MDR certification has effectively become a prerequisite, with global acquireers and distributors increasingly applying it as a critical criterion in product selection.
The newly certified “New DIO NAVI Master KIT” is a core solution designed to maximize the precision and efficiency of implant procedures. The “New Dr. SOS KIT” is configured to enable rapid response to various unexpected situations that may arise during clinical procedures, featuring enhanced usability and versatility.
“Having secured Class IIa certification following our Class IIb MDR certification, our major product lines now meet the latest regulatory standards in the European market,” DIO CEO Kim Jong-won stated. “We will launch our full product lineup not only across Europe, including our strategic markets of Portugal and Türkiye, but also in Asia, the Middle East, Africa and other global markets to expand our market share.”
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