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.

Paula Gomes

Meet our experts

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. Strong, statistically relevant clinical data demonstrating the safety and performance of your device is essential to ensuring a successful outcome of your MDR application.

Our Active Technical and Clinical Specialists have a broad range of industry and regulatory experience, including product design and development, manufacturing and testing. They will support you through the process of certifying your device. We are experienced in working with manufacturers of ablation devices, body-worn sensors, hearing aids, infusion pumps, ventilators, software devices, surgical robots and lasers as well as, radiation therapy, ultrasound and x-ray machines and many others.

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