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.
More topics to explore
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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
Kiwa India joins the 10th Annual Medical Device Regulatory and Quality Summit 2026 as Gold Partner
Kiwa India is proud to announce its participation as a Gold Partner at the 10th Annual Medical Device Regulatory and Quality Summit, taking place on 18–19 August 2026 at Pride Plaza, Aerocity, New Delhi. This event brings together key industry leaders, regulators, and innovators to shape the future of medical device compliance and quality in India.
Kiwa launches Medical Operations in India to support medical device manufacturers with transparent and efficient certification services
Kiwa announces the launch of Kiwa India Medical, a new business dedicated to medical device certification and regulatory assurance in India. This initiative aims to provide manufacturers with reliable, transparent, and efficient certification services, supporting their access to global markets.
Digitalization of Technical Documentation
The evolution of the European regulatory framework for medical devices is establishing a progressive transition toward natively digital healthcare information management models. Within this context, the entry into force of Implementing Regulation (UE) 2025/1234, which supplements and amends the provisions of the previous Regulation (UE) 2021/2226, marks a structural shift for the entire MedTech sector.
Kiwa Supports India’s MedTech Ambitions at GRIT Gandhinagar 2026
Kiwa was proud to participate in the GRIT Gandhinagar 2026 conference, “Gujarat to Global: Empowering the MedTech Ecosystem,” held on 23 June 2026 in Gandhinagar, Gujarat, India. The event brought together policymakers, regulatory experts, industry leaders, and medical device manufacturers to discuss how India’s rapidly growing MedTech sector can strengthen its position in global markets.
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