Medical devices are a heterogeneous category of products, such as active equipment, implants, reusable instruments, substances and materials, Sw, and more. All of them intended for use on humans and therefore their safety and performance are of vital importance. To be put on the market and traded in EU, medical devices must comply with pertaining European legislations.
We can provide complete and reliable information on the appropriate medical devices certification process to undertake, and deliver qualified conformity assessment activities and related services.
The procedure to follow to obtain the CE Mark can be different depending on the risk of the medical device and it needs to meet the essential requirements defined by the (EU) 2017/745 Regulation and subsequent amendments.
Medical device’ means any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes
The EU has a competitive and innovative medical devices sector, characterised by the active role of small and medium-sized enterprises. It is supported by a regulatory framework that aims to ensure the smooth functioning of the internal market, taking as a base a high level of protection of health for patients and users.
Choose Kiwa Medical as your Notified Body partner and embark on a journey that transforms regulatory compliance into a strategic advantage. Our commitment to excellence, regulatory prowess, and client-focused approach makes us the ideal partner for bringing your medical devices to market successfully.
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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