Regulatory Requirements for Medical Equipment

Testing & Certification to Harmonized Standards and Regulatory Requirements for Electrical Safety and EMC

To bring your medical device to North American, European and global markets with speed and efficiency, you need a testing and certification partner who knows your business. Count on Intertek for auditing, Notified Body approvals, and compliance testing and certification to global standards and requirements, all from a single source.

IEC 60601-1, 3rd Edition Standard
Your new and existing medical devices must demonstrate compliance with the latest revision of IEC 60601-1. Navigate the new requirements of the 3rd Edition with Intertek and reach your target markets.

IEC 60601-1-2:2007 Electromagnetic Compatibility
Access the world’s largest network of EMC laboratories and discover our complete testing solutions per IEC 60601-1-2 and EMC Directive specifications for your medical device.

EU Medical Devices Regulation (MDR 2017/745)
Before you can market your medical device in the EU, your product must meet the essential requirements of the MDR and bear the CE Mark.

In Vitro Diagnostic Directive 98/79/EC
Give your in vitro diagnostic device a head-start to achieving EU market access. We can help you address essential requirements of the IVDD and prepare your Declaration of Conformity.

The CB Scheme
Our global market entry program is your key to accessing the world’s fastest growing medical device markets. Learn how you can obtain multiple national safety certifications for your product and gain entry into more than 50 countries.

EU RoHS 2 Recast Directive 2011/65/EU
Our global expert network provides you a single-source solution for RoHS compliance, including technical documentation, BoM assessment, testing, consulting, and product certification.

Intertek does not provide consulting services for management systems certification. Any consulting activities provided by Intertek are separate and independent from certification activities.