The RoHS Recast Directive for manufacturers and importers became law on January 3rd, 2013 and medical devices will also need to be compliant with the regulatory requirements starting in July 2014. This will require all medical device manufacturers to remove a number of hazardous substances from the electronic components they currently use and make adjustments to their ongoing development and quality assurance processes.
This broadens the scope of the original RoHS Directive 2002/95/EC to include medical devices, in-vitro diagnostic medical devices, and industrial monitoring and control equipment. Both the manufacturer and the importer are legally responsible for compliance and the staggered compliance deadlines for the newly included equipment types are:
July 22, 2014 | Medical Devices
July 22, 2016 | In-Vitro Diagnostic Medical Devices
July 22, 2017 | Industrial Monitoring & Control Equipment
July 22, 2019 | Electrical & Electronic Equipment (formerly outside of directive scope)
If you currently ship medical devices to Europe, or ever foresee this as a possibility, It is highly recommended you immediately begin the process of:
Scrubbing your Bill of Materials
Performing XRF Chemical Testing and Analysis
Compiling a Technical Construction File
Conducting Risk Assessment of Materials and/or Manufacturing Processes
RBC Medical Innovations is an ISO 13485 | ISO 9001 certified and FDA registered contract medical device manufacturer with the available resources and capabilities to provide commercial production solutions for your FDA PMA / 510(k) or CE marking medical devices. To support the legislative requirements of the recast directive, we are offering a RoHS 2 Compliance Review Service to ensure your device is delivered to market on target, on time, and on budget.
