Medical Devices News

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.

On 16 March 2026, the European Commission hosted the High-Level Conference on Medical Devices: Innovation and Patient Safety in Brussels, an event that brought together key institutional representatives, regulatory authorities, industry experts, and stakeholders from across Europe.

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.

As a medical device manufacturer, choosing the right Notified Body is a critical strategic decision. You need a partner that not only understands the regulatory landscape but also operates with the highest standards of quality. It's not just about ticking boxes, it's the bedrock of trust we build with you, the medical device manufacturer, ensuring that when we give a medical device the thumbs up, it's genuinely safe and performs as it should.

The AIB 2025-1 MDCG 2025-6 guidance document represents a major milestone for medical device manufacturers across the European Union. It clarifies the interplay between the Medical Device Regulation (MDR), In Vitro Diagnostic Medical Device Regulation (IVDR), and the newly adopted Artificial Intelligence Act (AIA, offering comprehensive direction for compliance in this emerging landscape.