Medical Devices News

At Kiwa Medical, the four eyes principle is more than a procedural requirement—it is a daily safeguard for technical quality and regulatory confidence. Whether applied to peer reviews of audit reports, technical documentation assessments, or certification decisions, involving a second qualified reviewer before finalization adds real and measurable value.

This is an important step in Kiwa’s continued development of services for the medical device sector. Applicant status means Kiwa has entered the formal process toward recognition as an MDSAP Auditing Organization.

Annex XVI of EU MDR 2017/745 covers specific product groups that do not have a medical intended purpose, yet are used on the human body and inherently carry certain risks. Although these products are not intended for diagnosis or treatment, they are included within the MDR framework due to their potential impact on human health and safety.

From 5 to 8 May 2026, Lisbon will host a new edition of RAPS Europe, one of the leading European events dedicated to Regulatory Affairs in the life sciences and medical devices sector.

We are proud to announce that Kiwa Nederland has extended their CBTL accreditation with electrical safety testing of medical devices. This milestone allows us to support medical device manufacturers even more effectively in demonstrating compliance with international standards, not only for EMC, but now also for electrical safety. 

Since the introduction of MDR (EU) 2017/745, many manufacturers describe the regulation as demanding and time-intensive. And while MDR is thorough by design, many of the hurdles companies face stem from fragmented processes rather than the regulation itself.