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ROHS 2 for Medical Devices: Are You Ready?

Written by SPK Blog Post
Published on July 18, 2013

As of July 22, 2014, the RoHS (Restriction of Hazardous Substances) Directive must be observed for first time distribution of all medical devices to the full extent. Furthermore, all products with a CE marking must also be RoHS-compliant.

ROHS 2 Compliance Changes at a Glance

While no new substances have been added to the restricted substances, there are major changes to compliance requirements:

ROHS 2 Changes

Practical Implications for Medical Device Manufacturers

Complying with ROHS 2, in practice, will require the following steps:

ROHS Steps

How PLM Solutions Help Design for Environmental Compliance

As illustrated above, designing for environmental compliance requires four critical phases:

ROHS PLM

Comprehensive product lifecycle management (PLM) frameworks automate these phases along the entire product lifecycle. By integrating compliance data with their PLM systems, companies can view regulatory requirements, engineering bill-of-materials (EBOMs), manufacturing BOM (MBOM), and part material and substance data related to all product information, all in a single system, allowing for  a rapid response to regulatory and customer demands.

Next Steps:

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