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.
In the last year, structured dialogue has become an essential tool in collaboration between manufacturers and Notified Bodies under the MDR. New requirements, stricter deadlines enforced a need for more and structural communication.
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.
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.
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Artificial Intelligence (AI)-based software medical devices are revolutionizing the healthcare sector in diagnosis, treatment, and patient management. AI-powered Software as a Medical Device (SaMD) and Software in a Medical Device (SiMD) applications cover a wide range of solutions, from medical decision support systems to patient monitoring tools.
The rules for placing medical devices on the Great Britain (GB) and Northern Ireland (NI) markets differ primarily in terms of the timelines and regulatory frameworks
Registration of certain medical devices which are reusable Class I devices, upclassified Class I devices, and/or reliant on expired/expiring CE certificates in Great Britain (GB) and Northern Ireland (NI).
To register medical devices with the MHRA, manufacturers must follow specific requirements and procedures. In this article you will find the key steps and requirements.
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