Medical Device Testing and Certification

Carefully carried out testing by the experts at Eurofins makes it possible to identify unforeseen events at an early stage of development - and prevent cost-intensive delays for you.

Testing

Electrical medical equipment, also known as "active medical devices", are controlled by stringent regional and international approval procedures which include the required testing to be performed by approved and accredited laboratories.

In the field of active medical devices, these requirements are documented under the IEC 60601* standards family. This is the base for the approval procedure of Medical Electrical equipment in most global regulatory frameworks and for compliance with the Medical Device Directive (MDD) 93/42/EEC and MDR (EU) 2017/745.

In Vitro Diagnostic Medical Equipment requirements are documented under IEC 61010* for compliance with the In Vitro Diagnostic Medical Devices (IVD) Directive 98/79/EC and IVDR (EU) 2017/746.

Certification

Eurofins has several Notified Bodies in Europe which work in synergy with the National Certification Body (NCB). At various locations in Switzerland there are testing laboratories of certification bodies (CBTL) in accordance with the CB Scheme for Electrical Medical Devices.

In order to ensure safety and legally place medical devices on the market, manufacturers must comply with a broad range of stringent regulations and standards.

This includes the need to be certified by designated Notified Bodies (NB), recognized Certification Bodies and laboratories according to the classification of the medical device based on its associated potential risks.

The carefully carried out testing by the experts at Eurofins make it possible to identify unforeseen events at an early stage of development - and prevent cost-intensive delays for you.

Our testing services include

• Electrical Product Safety
• EMC
• Radio & Wireless
• Environmental Simulation

Certification services for the USA and Canada can easily be handled via Eurofins MET Labs. CB-Report and MET Labs certification from a single source guarantee an optimized process.