Medical Devices No Longer Exempt

Medical devices are no longer exempt from the RoHS and REACH Directives.

If you haven’t converted to RoHS and documented REACH completely, you have exposure. And that puts your existing FDA approval at risk.

If your company is having component issues because your suppliers are switching to RoHS (lead free) compliant parts, you are definitely not alone.

What has changed?

As component suppliers are moving towards “lead free only” and discontinuing your leaded parts, you will be faced with redesign issues.

China RoHS and Medical devices

China RoHS required product marking for all electronic products beginning on March 1, 2007, including medical equipment. And unless you have supporting documentation down to the material level on all sub-assemblies, you will not survive a marking audit.

We can help

We are experts at Medical RoHS analysis and conversions

We help keep your staff focused on future products, not redesign work, by collaborating with them to convert your existing products to be RoHS compliant, while maintaining your FDA approval status.

And we do it cost-effectively. RoHS compliance is a major focus of Lead Free Design.

Why use Lead Free Design?

We have engineering and manufacturing specialists with experience in FDA compliance, electrical and electronic design, mechanical design, plastics engineering, metallurgy, hydraulics and pneumatics. Though some engineering firms have RoHS experience, we have the FDA Medical Device expertise you require.

During the conversion process, we work closely with your team (design, verification, documentation, supply chain, testing, manufacturing), so that your RoHS documentation is always up to date and available, leaving your engineers to focus your next generation of products.

Waiting Until You Get Caught

We’ve helped clients in emergency situations, and then followed with lower cost, lower stress planning for compliance going forward.

Stuff happens. But this a problematic strategy to follow consciously.

  • The timeframe to get compliance documents from suppliers is usually too long. Especially if you are not a major customer of theirs.
  • Without the time needed to get compliance docs from suppliers, much more lab testing is needed, greatly increasing the cost.
  • Lab upcharges for expediting testing can be 50% or higher.
  • Depending on the Directive or Regulation, some EU courts have ruled that “a reasonable time for transmission” of compliance documentation is three days – the time it takes for Fedex to deliver the documents.
  • Squeezing the schedule too hard invites errors.
  • CE “Market Surveillance” means once you’re caught in one EU country (“member state”), national authorities are obligated to inform the other member states. This rapidly causes import problems in all EU member states.
  • Once you’re caught, authorities tend to look at your documentation very closely. For this and future shipments.

In other words, please don’t let this happen to you.

What is WEEE Recast?

Waste Electrical and Electronic Equipment Directive 2002/96/EC (WEEE) set collection, recycling and recovery targets for electrical goods and is part of a legislative initiative to solve the problem of huge amounts of toxic e-waste. It was replaced by DIRECTIVE 2012/19/EU, called WEEE Recast. The WEEE Directive requires each member state to transpose the Directive into its own regulations. In effect, this creates a different implementation in each country, including varying requirements for registering and reporting.

What is included

WEEE applies to Electrical and Electronic Equipment (EEE). Unlike RoHS 2, the definition of EEE stays the same: “equipment which is dependent on electric currents or electromagnetic fields in order to work properly”.

WEEE Directive In Plain English

There are not enough landfills for trash in many parts of Europe; electronics tend to leach chemicals into groundwater when put in a landfill. WEEE is designed ensure that recycling happens more and more. Retail stores are obligated to take electronics back from consumers at no charge. Business to business commerce is a little different. Producers that sell Electrical and Electronic Equipment (EEE) are obligated to register in each member state where their EEE is sold. They are also obligated to recycle EEE that they sold. In a nutshell, you’re the “Producer” if your name is on the product label.

There are three steps:

  1. Register in each country (member state)
  2. Report total weight sold in that member state
  3. Arrange for shipping to a recycler

Registration is different for each country. Reporting is different for each country: some annual, some quarterly, some monthly, each may have different categories of reporting. Each member state has it’s own billing calculation for total products imported by weight.

There are several ways to accomplish recycling in each member state, including the Producer joining a compliance scheme as a member, arranging to have relevant products recycled, and in some cases shipping the product to the recycler.

Lead Free Design has the experience to assist you in WEEE compliance customized for your requirements and distribution system.

WEEE vs. WEEE Recast

We are in a transition period until August 15, 2018. In addition to new recovery targets, the number of categories changes from ten to the following six:

  1. Temperature exchange equipment
  2. Screens, monitors, and equipment containing screens having a surface greater than 100 cm2
  3. Lamps
  4. Large equipment (any external dimension greater than 50cm) including, but not limited to: Household appliances; IT and telecommunication equipment; consumer equipment; luminaires; equipment reproducing sound or images, musical equipment; electrical and electronic tools; toys, leisure and sports equipment; medical devices; monitoring and control instruments; automatic dispensers; equipment for the generation of electric currents. This category does not include equipment included in categories 1 to 3.
  5. Small equipment (no external dimension more than 50cm), including the same type of products as large equipment, except for Small IT equipment, which is treated as a separate category.
  6. Small IT and telecommunication equipment (no external dimension more than 50 cm)

Exclusions to WEEE requirements are now backed up by clear definitions, of particular interest are definitions for the “Large Scale” equipment exclusions.

Exclusions of interest are:

  • equipment designed to be sent into space
  • large scale industrial tools
  • large-scale fixed installations
  • equipment specifically redesigned for R&D and are only available on a business to business basis
  • medical devices and in vitro diagnostic medical devices, where such devices are expected to be infective prior to end of life, and active implantable medical devices.