Implantable medical devices

Implantable medical devices, remaining in the human body for a long-term period, must meet strict requirements under the Medical Device Regulation (MDR) 2017/745 to ensure they are safe and effective for patients. Consequently, these devices are subject to more stringent provisions compared to other types of medical devices under the MDR.

Specific requirements for implantable medical devices pertain to the source of clinical data, the implementation of processes to ensure patient safety, and the provision of information regarding the safety and performance aspects of these devices.

Additionally, the conformity assessment procedure for implantable devices involves extra steps for a thorough verification of the clinical data supporting the manufacturer’s clinical evaluation report, compared to other types of devices. Even more rigorous regulatory requirements apply if the product is an active implantable medical device (AIMD). 

We handle implantable medical devices in multiple ways

What can we do for you

At Starodub, we offer specialized services tailored to assist in the development and regulatory compliance of implantable medical devices, including AIMD. Our comprehensive approach ensures that your products meet all necessary MDR requirements and are thoroughly prepared for the conformity assessment procedure.

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Iryna Berchak
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Iryna Berchak
RA Manager
Iryna Berchak

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Talk to an expert