Medical Devices News

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.

At Kiwa Assurance, we recognize that innovation is a constant in the medical device industry. But change comes with responsibility—especially when it comes to maintaining compliance under the MDR and ISO 13485. That’s where our Notification of Change (NoC) process plays a vital role.

At Kiwa Assurance, we recognize that innovation is a constant in the medical device industry. But change comes with responsibility—especially when it comes to maintaining compliance under the MDR and ISO 13485. That’s where our Notification of Change (NoC) process plays a vital role.

Under Article 52 and Annexes IX through XI of the Medical Device Regulation (MDR), it is the legal manufacturer's responsibility to select the appropriate conformity assessment route. However, as a Notified Body, we often observe confusion regarding what these assessments entail and which route is best. The correct choice depends on the device classification and the level of control the manufacturer maintains over design and production.

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.

Under the European Union's medical device regulations, MDR (EU 2017/745) and IVDR (EU 2017/746), it has become mandatory for all devices to be included in a common classification system. This classification system is defined as the European Medical Device Nomenclature (EMDN) and plays a critical role in the placing of devices on the market, traceability and technical file content.