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.

Frequently Asked Questions about Medical Devices

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Cyber Security

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.

Notified bodies for medical devices

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.

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. 

Medical related news

AIB 2025-1 MDCG 2025-6 : A Guiding Document for AI-Powered Medical Devices

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.

AIB 2025-1 MDCG 2025-6 : A Guiding Document for AI-Powered Medical Devices

EMDN Codes: Hierarchical Structure and Application

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.

Post-Market Surveillance: Key Considerations for Medical Device Compliance

Post-market surveillance (PMS) has undergone significant transformation under the Medical Device Regulation (MDR) in Europe. It marks a new era in the monitoring and reporting of medical device safety and performance. This set of requirements emphasizes the proactive collection and analysis of medical device-related data after a product is placed on the market, allowing manufacturers to reassess the safety and effectiveness of their medical devices continuously.

Celebrating the Importance of International Standards

Join us in celebrating World Standards Day on October 14! Explore how international standards shape a safer, more sustainable world and see how Kiwa is contributing to global progress through our commitment to the Sustainable Development Goals (SDGs). Discover more about our role in building a better future.

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Follow our Kiwa Medical showcase on LinkedIn for the latest updates on healthcare standards, certifications, and innovations. Join the conversation and stay informed!

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