Seamless Transfer Program: switch Your MDR EU Notified Body or ISO 13485 Certification Body — without delays or disruption

Hands selecting blue blister pack medicine from pharmacy shelf with boxes of medication in the background

Changing your MDR EU Notified Body or ISO 13485 Certification Body can be complex, time-critical, and risky if not managed carefully.

With our Seamless Transfer Program, Kiwa Assurance (NB 1912) supports medical device manufacturers in transferring with confidence—ensuring full control over timelines, certification continuity, and communication.

We combine deep regulatory expertise with a structured, service-driven approach, delivering a predictable and interruption-free transfer—so your CE marking and ISO 13485 certification remain secure, and your market access uninterrupted.

What you can expect

Speed & Predictability

Dedicated transfer slots provide immediate clarity on timelines, milestones, and decision points—so you know exactly where you stand from day one.

Full Transparency

A clearly defined process, realistic planning, and a single point of contact eliminate uncertainty throughout the entire transition.

Proven MDR & ISO 13485 Expertise

Our specialists have in-depth experience across product categories, ensuring your device is assessed by experts who understand both the technology and regulatory landscape.

Continuity Guaranteed

We safeguard certification continuity, minimizing risk and preventing unnecessary gaps in compliance or market access. You will have a dedicated contact guiding you throughout the transfer—and beyond.

Service-Driven Communication

Expect clear, jargon-free communication and consistent updates, keeping all stakeholders fully aligned at every stage.
Blurred hospital ICU with medical monitors in the foreground and two healthcare workers attending a patient in the background.

CE Marking of Medical Devices in accordance with MDR

Medical Devices are an heterogeneous category of products, such as active equipment, orthopaedic implants, reusable instruments, substances and materials, software, and more. These devices, designed for medical purposes and intended for use in or on humans, achieve their primary effects through mechanisms other than pharmacological, immunological, or metabolic actions. Before entering the European Economic Area (EEA) market, the medical devices need to be compliant to applicable legislation and obtain the CE marking.

ISO 13485 Medical Devices

ISO 13485 is the medical device industry's quality management system (QMS) standard. The scheme specifies the requirements for a quality management system for medical devices.

Contact us

If you are considering a transfer, we are here to make the process structured, transparent, and seamless.

Contact us filling the form!