In our recent experience, manufacturers of IVD equipment are using this opportunity to further enhance their products – perhaps adding a touchscreen, new interface or Wi-Fi – by bundling these changes as part of the RoHS compliance upgrade. However, while the RoHS 2 update does offer some scope to also update a product’s design, the firm deadline means manufacturers will need to conduct a precise analysis of the activities required to ensure their product is ready on time.
Any modifications to an IVD instrument must be followed by verification, validation and regulatory submissions before transfer to production. The duration of these activities will be proportional to the product’s complexity. Care must also be taken to ensure that a seemingly benign component change does not result in additional verification and validation activities. Be prepared to work closely with your RoHS compliance team, whether they are internal or external to your organization to ensure they have a comprehensive, systems-level understanding of the product.
The process of updating a legacy IVD product will also highlight any gaps in your suppliers’ understanding of RoHS. Educating your supplier base can take time, especially if their business is not EU-focused. Now is not the time to revolutionize your product or embark on anything but the most straightforward of design enhancements. Better still, just focus on best practice in achieving your RoHS compliance.