Medical Devices News

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.

Any medical device that makes use of software, or is a software in itself (MDSW), could potentially fall under the Regulation 2024/1689 (informally known as ‘AI act’), if the software, or part of it, meets the definition as laid down in this Regulation*. For devices falling under the AI Act, the deadline of August 2, 2027, is fast approaching, considering the timelines for conformity assessment.  

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.

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.

Post-market surveillance (PMS) has undergone significant transformation under the Medical Device Regulation (MDR) in Europe. It marks a new era in the monitoring and reporting of medical device safety and performance. This set of requirements emphasizes the proactive collection and analysis of medical device-related data after a product is placed on the market, allowing manufacturers to reassess the safety and effectiveness of their medical devices continuously.