Medical devices
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.
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How do I get my medical device certified?
The procedure to obtain the CE Mark can be different depending on the risk class of the medical devices according to art. 52 of the (EU) 2017/745 Regulation.
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What is a medical device?
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
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EU information and factsheet for manufacturers
Medical devices and In Vitro Diagnostic medical devices (IVDs) have a fundamental role in saving lives by providing innovative healthcare solutions for the diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease.
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Read the latest news
MDCG 2026-4 is published: new transitional process for SSCP Management in EUDAMED
The MDCG published MDCG 2026-4 – Management of SS(C)P in EUDAMED after mandatory use in June 2026. The document explains how SSCP documents will be managed in EUDAMED during the transition following the start of mandatory use on 28 May 2026.
Position Paper of Team NB adopted: MDR Certification Process (including Pre-application, Application and Post Application phases)
The Position Paper “MDR Certification Process (including Pre-application, Application and Post Application phases) – Consensus document” was adopted by the Team NB members and published on December 18th 2024. This Position Paper is applicable to both legacy devices (pursuant to Article 120) transitioning to MDR, and devices that are new to the market and have not been certified under the Directives before and is aligned to the requirements of MDR
EU Commission Announces Four EUDAMED Modules as Fully Functional -MDR/IVDR Transition Periods Officially Begin
On 26 November 2025, the European Commission published Commission Decision (EU) 2025/2371, officially confirming that four key modules of EUDAMED are now fully functional. This announcement triggers the start of the transition periods for certain obligations under Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR).
EU: Commission publishes second draft of GPAI (General Purpose Artificial Intelligence) code of practice
On December 19, 2024, the European Commission published the second draft of the 'General-Purpose AI Code of Practice.' Independent experts present the second draft of the General-Purpose AI Code of Practice, based on the feedback received on the first draft, published on 14 November 2024.
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