Active Medical Devices

Active Medical Devices

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Active Medical Devices
Active Medical Devices
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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 The Netherlands (2797) is a leading Notified Body; we review medical devices to ensure that they conform to the requirements of the European Directives and Regulations. BSI UK (0086) is a UK Approved Body able to provide conformity assessments under the new UKCA scheme. 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