ESMA Updates Guidance for Medical Devices

UAE RoHS Compliance Deadline January 1, 2020

28 October 2019

The United Arab Emirates (UAE) has implemented regulations (UAE RoHS) to control hazardous materials in electrical and electronic devices. Decision No. 10 of 2017 under UAE RoHS, requires Category 8 (Medical Devices) and Category 9 (Monitor and Control Devices) to comply starting January 1, 2020.  This means that the entities responsible for placing these products on the UAE market must adhere to the certification requirements set forth by The Emirates Authority for Standardization & Metrology (ESMA) by this date to continue selling in this market.

What you need to know...

On October 13, 2019, ESMA issued new guiding principles for the implementation of UAE RoHS specific to Category 8, Medical Devices. This new guidance effects the certification process of Medical Devices which are sold Business to Business (B2B), and Business to Consumers (B2C).

The major changes include:

  1. A Declaration of Compliance, V4.0, that does not include the requirement to identify 3 critical Bill of Material (BOM) items and applies to both the Emirates Conformity Assessment Scheme (ECAS) and the Emirates Quality Mark (EQM) certification process.
  2. The elimination of material testing reports for 3 critical BOM items, which were previously required for ECAS Certification.
  3. Reference added to include the technical documentation for the assessment of electrical and electronic products with respect to the restriction of hazardous substances (IEC 63000:2016 or EN50581:2012) for the Declaration of Conformity (DoC)

All previously identified requirements remain in effect.

As mentioned in our previous blog (UAE RoHS Enforcement), ESMA has announced that they are vigorously enforcing the requirements of UAE RoHS.

For more information on our services, visit: http://www.intertek.com/regulatory/consulting/uae-rohs/

 

Kenneth Stanvick,
Senior Consultant,
Global Restricted Substances (GRS),
Health Environmental and Regulatory Services (HERS)

 

Today's expert blogger is Mr. Kenneth Stanvick, who has been providing regulatory expertise to the chemical industry for over 17 years. He has extensive experience navigating global environmental compliance regulations, including EU RoHS, EU WEEE, EU Battery Directive, EU REACH, Energy Star, China RoHS, and Cal Prop 65, UAE RoHS. Ken conducted numerous onsite training and educational seminars to product manufacturers and their suppliers in China, Hong Kong, and Taiwan, EU, North and South America. Additionally, he has developed and implemented "smart testing" to eliminate unnecessary material testing for restricted, banned or declarable substances based upon the identification of high-risk materials, which reduced testing and saved customers time and money.