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.
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.
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.
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.
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