The IECEE CB Scheme and Medical Devices

Access growing Medical Device Markets around the world with IECEE CB Scheme Testing and Certification from Intertek's four IECEE National Certification Bodies

The IECEE CB Scheme offers a one-stop approach to obtain multiple national safety certifications with a single CB Test Certificate and Report.

The IECEE Scheme, based on IEC and ISO harmonized international standards, allows for a true one-stop approach to obtain multiple national safety certifications with a single CB Test Certificate and Report. The program helps reduce trade barriers caused by different certification requirements in different countries, allowing Medical Device manufacturers to access existing, new and developing global markets. It eliminates delays and costs for repetitive testing, allowing companies to market their products faster while reducing overall costs.

Differences between the EU MDD and the MDR
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Countries Participating in the CB Scheme

Argentina
Australia
Austria
Bahrain
Belarus
Belgium
Brazil
Bulgaria
Canada
Chile
China
Columbia
Croatia
Czech Republic
Côte d'Ivoire
Denmark
Finland
France
Germany
Greece
Hungary
India
Indonesia
Ireland
Israel
Italy
Japan
Kenya
Republic of Korea
Malaysia
Mexico
Netherlands
New Zealand
Nigeria
Norway
Pakistan
Poland


Portugal
Russian Federation
Saudi Arabia
Serbia
Singapore
Slovakia
Slovenia
South Africa
Spain
Sweden
Switzerland
Thailand
Turkey
Ukraine
United Arab Emirates
United Kingdom
United States of America
Vietnam

Local Testing for Worldwide Safety Compliance

Through our global network of testing labs, Intertek possesses four National IECEE CB Scheme Certification Bodies (NCBs) in Singapore, Sweden, the United Kingdom and the United States of America for more than 45 associated CB Testing Laboratories worldwide.

*The Intertek legal entities that provide medical device management system certification services (including ISO 13485 and MDSAP) and Notified Body services (MDR 2017/745 and MDD 93/42/EEC) do not provide any consulting services. Clients who have used other Intertek legal entities’ consulting services are not eligible to receive management system certification services or Notified Body services from Intertek.