Active Medical Devices

Unrivalled expertise from an Active Devices Notified Body

Active Medical Devices BSI

As a manufacturer of an active device, you must ensure that you meet the relevant requirements outlined in the Medical Device Regulation (MDR) (EU) 2017/745.

As an Active Devices Notified Body our technical specialists have years of experience and can support you through the process of bringing your medical device on to the EU market.

What is an active medical device?

An active medical device is defined in the MDR as “any device, the operation of which depends on a source of energy other than that generated by the human body for that purpose, or by gravity, and which acts by changing the density of or converting that energy.” 

Where products require additional expertise, we collaborate with our in-house teams covering all areas from dental, ophthalmic, orthopaedic and vascular, to active implantable, medicinal substances, devices utilizing animal tissue and sterile devices.

BSI is the only organization with two Notified Bodies, one in the UK (0086) and one in the Netherlands (2797); both of which have full scope designations to the IVDR and MDR. Our Active Devices team has a broad range of industry and regulatory experience, including product design and development, manufacturing, testing and regulatory expertise, and is able to offer CE certification services for active devices under the MDR. Examples of products we cover include:

  • Body-worn sensors
  • Hearing aids
  • Heart-lung machines
  • Infusion pumps
  • Patient monitors
  • Patient ventilators
  • Radiation therapy
  • Software devices
  • Surgical lasers
  • Surgical robots
  • Ultrasonic devices
  • X-ray machines

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