Did you know that EN 60601 is part of several schemes globally?

Several schemes operate for EN 60601 to facilitate compliance, certification, and market access for medical electrical equipment. Below we provide an overview of a few key ones.

1. IECEE CB Scheme: the IECEE CB Scheme is a multilateral certification system based on IEC International Standards. Its members use the principle of mutual recognition (reciprocal acceptance) of test results to obtain certification or approval at national level around the world. It allows manufacturers to obtain CB test Certificates, which can be used as a basis for obtaining national certifications or approvals in 53 member countries round the world
2. European Union (EU) Medical Device Regulation (MDR): the EU MDR is a regulatory framework for medical devices in the European Union. It includes specific requirements for medical electrical equipment, including conformity assessment procedures, documentation requirements, and the involvement of Notified Bodies for higher-risk devices compliant with EN 60601 which are an important aspect of demonstrating conformity with the EU MDR
3. US FDA 510(k) Clearance: in the United States, medical electrical devices are subject to clearance by the US Food and Drug Administration (FDA). Manufacturers typically need to submit a 510(k) premarket notification to demonstrate that the device is substantially equivalent to a legally marketed device and meets the safety and performance requirements
4. Japan Pharmaceutical and Medical Devices Agency (PMDA): the PMDA oversees the regulation and approval of medical devices in Japan. Medical electrical equipment intended for the Japanese market must undergo the appropriate conformity assessment procedures and fulfil the requirements set by PMDA
5. Health Canada Medical Devices Regulations: Health Canada regulates medical devices in Canada. Manufacturers of medical electrical equipment need to comply with the requirements outlined in the Medical Device Regulations, including conformity assessment, licensing, and labelling requirements
6. Australian Register of Therapeutic Goods (ARTG): in Australia, medical electrical equipment is regulated by the Therapeutic Good Administration (TGA). Manufacturers must meet the regulatory requirements, including conformity assessment, registration on the ARTG, and should be in compliance with applicable standards such as EN 60601

These schemes and regulations are just a few examples of the frameworks and processes involved in ensuring compliance and market access for medical electrical equipment. It is essential to thoroughly research and understand the specific requirements and schemes relevant to your target market to successfully navigate the regulatory landscape for EN 60601.

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