Medical Devices News

Changing your MDR EU Notified Body or ISO 13485 Certification Body can be complex, time-critical, and risky if not managed carefully. With our Seamless Transfer Program, Kiwa Assurance (NB 1912) supports medical device manufacturers in transferring with confidence—ensuring full control over timelines, certification continuity, and communication.

At our recent RAPS session in Lisbon, one message clearly emerged: under MDR (EU) 2017/745, clinical evidence is a continuous lifecycle process that depends on the strength of the entire ecosystem.

Biological evaluation is a fundamental element in demonstrating the safety of medical devices and compliance with Regulation (EU) 2017/745 (MDR). The ISO 10993 series represents the internationally recognized standard for assessing the biocompatibility of materials and devices throughout their entire lifecycle.

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.

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.