What is an active medical device?

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

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 clinicians and technical teams covering all areas from dental, ophthalmic, orthopaedic and vascular, to active implantable, medicinal substances, devices utilizing animal tissue and sterile devices.

BSI has 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 medical devices specialists have a broad range of industry and regulatory experience, including product design and development, manufacturing, testing and regulatory expertise. We are able to offer CE certification services for active medical devices under the MDR. Examples of products we cover include:

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

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