Active Medical Devices

As a Notified Body under the Medical Device Directive 93/42/EEC, we can provide robust, efficient reviews against the requirements for your active device.

In Vitro Diagnostics

As an IVD Notified Body, our team of technical specialists can support you with assessment against the requirements of the IVD Directive 98/79/EC so that you can place a CE Mark on your device and access the European market.

Mobile Devices

As a Notified Body, we have world-leading product specialists in the Active Devices and Active Implantable Medical Devices teams with a wealth of experience to understand the complete range of mobile devices.

The preferred choice for product expertise

Over 70% of the top medical device companies work with BSI, and our profound expertise enables us to build long-term relationships with our customers.

BSI employs over 120 medical device experts with experience in all aspects of the product lifecycle including research and development, manufacturing, and quality assurance. We offer specialized in-house expertise in areas ranging from sterilization processes, and animal tissue utilization to combination medical device products.

Our core competencies and unique skills are calibrated to handle our customer’s extensive portfolio of medical technologies.

Why choose BSI as your notified body?

  • Product expertise – our diverse and experienced team brings in-depth knowledge and understanding of complex medical device technologies.
  • Global access – we operate in over 180 countries with more than 100 years of experience and offices around the world to serve you.
  • Timely market access – providing flexible solutions for manufacturers needing efficient pathways to global markets.
  • Confidence – our stringent review process combines speed with experience, integrity, independence and predictability.
  • Experience – our team has over 1750 years’ combined industry and regulatory experience, so we understand the challenges you face.