The onset of REACH, RoHS, and other environmental regulations will transform how medical device companies manage their supply chains.

REACH (Registration, Evaluation, Authorization and Restriction of Chemicals), enacted by the European Parliament and Council in December 2006, regulates all materials and substances made in, or imported to, the EU, as well as all articles made of substances. Obligations for chemical manufacturers and importers under REACH started in December 2008, while notification requirements began Oct. 28, 2008, for manufacturers that use Substances of Very High Concern (SVHC). Seven substances are currently designated as “priority SVHCs” (see box on next page).

REACH's goal is to protect human health and the environment by understanding the risks associated with chemicals and how users can use them safely. It would not be surprising if REACH eventually becomes the basis for a global standard. Health Canada has adopted similar regulations, meaning the use of certain substances is already restricted in Canada, and other nations are working on related efforts.

It is also important to note that the EU's Restriction of Hazardous Substances Directive (RoHS) will begin applying to medical devices in 2014 under a proposed recast. RoHS restricts the use of six categories of substances: lead, mercury, cadmium, hexavalent chromium, polybromated biphenyls (PBB), and polybromated diphenyl ether (PBDE).

It is a good idea for medical device companies to coordinate compliance activities. Instead of going after REACH and RoHS, many companies are including other regulations such as the Stockholm Convention on Persistent Organic Pollutants (POPS), an international treaty that banned nine substances and restricted four others. “It's best to put them all together and figure out what overlaps,” says Scott Wilson, content solution strategist for IHS Inc, Englewood, CO.

Supply chain risk

REACH has tremendous implications for the medical device industry. All companies that supply products to the EU must comply, and significant penalties may result for firms that do not. (Each member-nation determines its own penalties.) There are no exemptions for medical products, as has been the case for some previous environmental regulations such as RoHS. Now that the medical device sector has become a global industry with a global supply chain, the regulation will impact almost every device company.

Compliance is not as simple as making sure products no longer contain DEHP. Any number of substances could be added to the SVHC list in the coming years. Device firms must prepare themselves for the possibility that any substance currently used in their products could be eventually eliminated. They must also prepare their suppliers, and their suppliers' suppliers — going all the way back to raw materials — to change the composition of their products because of what gets added to the SVHC list, or even because of what is anticipated to be added.

“The ripple effect from REACH creates an entire supply chain risk,” says Rory King, senior manager at IHS. “It impacts the raw materials supplier, the component manufacturer, the intermediate manufacturer, the brand owner, and the downstream user. All have a regulatory obligation, especially the brand owner. You have to know what is in your products.”

Generally, medical device manufacturers primarily deal with their immediate suppliers and immediate customers. REACH changes this dynamic. Now, device firms must know what substances and materials are used by everyone along the entire supply chain. (The only experience many device companies have had with this was when latex allergies forced them to determine the latex content in their products, Wilson notes.)

In addition, some hospital systems, healthcare purchasing organizations, and other customers have begun to specify that products from their suppliers — the medical OEMs — indentify the presence of hazardous materials or comply with REACH and related regulations.