News/Blog

ROHS II will be Mandatory on July 22nd, 2014 for Medical, Control and Measurement Equipment

by G&M Compliance (May 2, 2013)

On July 22, 2014, the RoHS II legislative Directive becomes mandatory for medical devices, monitoring and control equipment placed on the market in the European Union. Manufacturers, importers and distributors have specific obligations in order to meet the objective of this Directive. One method for achieving a Presumption of Conformity to the RoHS II Directive involves the following steps:

A supplier and material confidence assessment

•Collecting supplier declarations, material declarations and analytical test results
•Reviewing the information collected for quality & trustworthiness
•An ongoing periodic assessment to ensure the process and output is accurate and current

The output of this process is expected to result in technical documentation for a product including:

•A general description of the product
•Documents for materials, parts and sub-assemblies
•Information showing the relationship between the technical documents and the materials, parts and sub-assemblies
•List of harmonized standards and/or other technical specifications used to establish the technical documents

For more information, please contact G&M Compliance, Inc. at 714.628.1020