The new RoHS 2 deadline is this July – can you make it?

Lab Worker and MachineCompanies exporting in vitro diagnostic (IVD) equipment to European Union customers have until July 22, 2016 to comply with the latest Restriction of Hazardous Substances Directive (RoHS 2) or risk losing access to the EU market. Invetech has assisted a number of companies in this space recently and with the deadline rapidly approaching, we wanted to briefly remind people of the opportunities and challenges that meeting RoHS compliance presents.

The deadline

The original EU RoHS directive came into force in 2006. It was not until the directive was ‘recast’ in 2011, however, that it captured equipment categories such as medical, in vitro diagnostic and industrial monitoring and control. Whether your company is an established manufacturer of IVD equipment or a start-up company embarking on a new IVD development program, you have until July 22, 2016 to comply with the recast RoHS directive.

Penalties for non-compliance will be proportionate to the nature of the breach, ranging from warnings or fines for individuals to the removal of products from the EU market and even the recall of products already sold.

Updating legacy IVD products

Many IVD products currently on the market were not designed to be RoHS compliant. The first step on the path to compliance is to undertake an analysis of the bill of materials to understand what components are used. Depending on the size and complexity of the equipment, this can take several months to complete.

The next step is to develop a replacement plan for any non-compliant materials identified. Invariably some redesign will be required. This could be as simple as changing label materials, or it may be more complex, such as a circuit board redesign or even a major OEM replacement. The bill of materials analysis may also highlight some components which, though RoHS compliant, are ‘not recommended for new designs’ or already obsolete.

Doing a last-time-buy on non-compliant materials is clearly not recommended as they will be unusable after the deadline. However, by using that material in the time remaining leading up to the deadline you may be able to avoid being left with a large inventory you can no longer use. You may also be able to use this material as spare parts for units sold before the deadline.

Complying with the new safety standards

Lab MachineAnother key standard for IVD laboratory equipment is the safety standard EN61010 Third Edition and its subparts. Although it was first published in 2010, widespread adoption of the third edition for IVD equipment was delayed until the release of certain crucial subparts of the standard. The long-awaited IVD subpart was finally updated in early 2015, meaning legacy IVD products will soon need to comply with both RoHS 2 and the third edition of EN61010.

Companies updating their products to be RoHS 2 compliant would be wise to take this opportunity to ensure they are meeting the new safety standard at the same time.

Migrating from the second to the third edition of the safety standard may require minor design changes which can be investigated in parallel with a RoHS 2 assessment.

Time is of the essence

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.