Active Medical Devices

Active Medical Devices

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Active Medical Devices
Active Medical Devices
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Placing your active medical devices on the market

As an active medical devices manufacturer, you must ensure that your product meets the relevant regulatory requirements before being placed on the market.

It is critical to work with an EU Notified Body or UK Approved Body that understands the industry and has the experience to review and confirm your product’s readiness for market.

  • Notified Body - BSI The Netherlands (2797) - reviews medical devices to ensure their conformity to the European Directives and Regulations.
  • Approved Body - BSI UK (0086) - provides conformity assessments under the UKCA Scheme.

We truly understand the challenges medical devices manufacturers face in bringing compliant products to market efficiently and safely. We offer a range of flexible product review services providing you with efficient pathways to bring your product to market.

What are active medical devices?

Active medical devices are defined 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.

For more clarity on active devices, please refer to the Medical Device Regulation (EU MDR) 2017/745.

Software as a medical device

Resources to support you

Why choose BSI for your product compliance to the MDR?

Used for a wide range of treatments in various specialized fields, active medical devices represent a significant and profitable segment of the healthcare industry. As a manufacturer of active medical devices, one of your biggest challenges in breaking into – or continuing your success in – this market is navigating the regulatory process efficiently.

Our active medical device specialists are not just experienced in the regulations; they are product experts who understand the specifics of these devices.

BSI Medical Devices is justifiably proud of its status in the industry as a full scope Notified Body, which includes active medical devices. Nowhere is this more apparent than in our level of experience; our specialist Active Medical Devices team has 43 technical experts, 6 clinical specialists supported by a body of internal clinicians, and 10 dedicated support staff.

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A notified body’s perspective on the clinical evaluation requirements under the Medical Device Regulation

jmdr articleUnderstanding of the clinical evaluation process for medical devices against the requirements of the MDR, relevant Medical Device Coordination Group guidance documents is critical for all manufacturers.

Hear from BSI’s Richard Holborow, Head of Clinical Compliance in his recent article in the Journal of Medical Device Regulation on the requirements for clinical evaluation under the MDR from a Notified Body’s perspective and how to meet those requirements.

Download the article

From the experts

The process of CE marking a medical device requires that you, as a manufacturer, fully understand the requirements applicable to your device and have clear, compliant and complete documentation.

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