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.

Product certification

Management System Certification

Laboratory Services

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.

Cyberattacks and threats can cause grave disruptions. Sensitive data can be lost or stolen and industrial processes could be halted, ultimately causing stagnation of production with revenue loss. It could even cause customers and public to lose trust in a company which became a victim of a cyberattack, leading to reputation damage.

Kiwa Cermet Italia (NB 0476) in Italy, Kiwa Belgelenddirme Hizmetleri (NB 1984) in Turkey, and Dare Services (NB 1912) in The Netherlands, are the Notified Bodies within the Kiwa Group, boasting a wide and in-depth experience in medical devices certification, with thousands of products already certified.

How do I get my medical device certified?

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.

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

EU information and factsheet for manufacturers

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.

Why choose Kiwa Medical

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.

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Medical related news

21 April 2026

MDR Annex XVI

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.

a young doctor conducting tests under a microscope

21 April 2026

Kiwa joins RAPS Europe 2026

From 5 to 8 May 2026, Lisbon will host a new edition of RAPS Europe, one of the leading European events dedicated to Regulatory Affairs in the life sciences and medical devices sector.

13 April 2026

Kiwa participates in the EU Commission High-Level Conference on Medical Devices

On 16 March 2026, the European Commission hosted the High-Level Conference on Medical Devices: Innovation and Patient Safety in Brussels, an event that brought together key institutional representatives, regulatory authorities, industry experts, and stakeholders from across Europe.

A Kiwa speaker is talking at the EU Commission High Level Conference on Medical Devices

7 April 2026

CBTL scope extension Electrical safety testing

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