26 Feb Environmental and Social Considerations for Medical Devices
In recent years regulators and law makers have given increased attention to ensuring that manufacturers of products sold in the United States, EU, and worldwide are socially and environmentally responsible. In this discussion, the Restriction of Hazardous Substances (RoHS) Directive and The Conflict Minerals Reporting Rule will be described. Industry members should also be aware of the myriad other regulations in effect, such as the REACH Legislation and Waste Electrical & Electronic Equipment (WEEE). These regulations have been met with both praise and criticism from industry members and political parties.
Regardless of how the regulations are perceived, the medical device industry, especially manufacturers, should be aware that socially responsible and environmentally friendly material sourcing and production of medical devices is paramount to continued market access.
Conflict Minerals Reporting Rule (S1502 of the Dodd-Frank Act)
The Conflict Minerals Reporting rule was issued on August 22, 2012, and the first reporting was due May 31, 2014. The rule states that manufacturers or contract manufacturers whose products contain conflict minerals must disclose this fact annually to the SEC. The aim of the rule is to deter financing (whether direct or indirect) of the violence occurring in the Congo and neighboring countries (1).
It is important to note that the Council of the EU, European Parliament and European Commission have been in negotiations regarding a European Conflict Minerals Regulation (2).
The Who, What, and How of Conflict Minerals Reporting
What are Conflict Minerals?
Conflict minerals originate in the Democratic Republic of Congo (DRC) and adjoining countries (See figure 1 for a list of “conflict” countries). The reason for the name “conflict”, as explained above, is that the trade of these minerals help to fund militia groups in the DRC, thus contributing to more than 5 million deaths since the 1990s (1).
The rule covers what is referred to as “3TG”:
Who must Report?
Any publicly traded company who files under the Exchange Act (SEC) and/or manufacturers or contract manufacturers who use 3TG as a necessary aspect of the functionality of production of their device or product (3).
How can a company ensure Compliance?
- Determine whether conflict minerals contribute to the functionality or production of your company’s final product. If yes, Section 1502 applies to your company (1).
- Conduct a “Reasonable Country of Origin Inquiry” for the supply chain to determine if any of the materials used in your product are sourced from the DRC or adjacent countries (see figure 1). This requires companies to contact suppliers and Smelter/Refiners in the supply chain to determine where the minerals used in production originate. A helpful tool to use is the Conflict Mineral Reporting Template (CMRT) for data collection (4).
- Even if your company is unable to determine the country, location, or mine of origin for conflict minerals, the process to do so should be recorded to demonstrate that you have made a “reasonable” effort to determine mineral origin.
- RCOIs should align with the process described in the OECD Due Diligence Guidance for Responsible Supply Chains of Minerals from Conflict-Affected and High-Risk Areas (1)
- Conduct Due Diligence and Create a Conflict Minerals Report (If applicable). The purpose of due diligence is to increase transparency and accountability in supplies chains. This process helps companies to determine if the minerals used in their product are “conflict-free” or not, and is essentially an audit of all smelters/refiners and suppliers of conflict minerals used in a company’s product.(1)
Figure 1: Countries of Risk (1)
Restriction of Hazardous Substances (RoHS) Directive – Recast (2011/65/EU)
The Restriction of Hazardous Substances direction acts to limit the allowable levels of dangerous materials in electrical and electronic equipment, including medical devices, in order to reduce human and environmental exposure to these materials. The RoHS directive was issued by the European Union first in 2002 and was “recast” (or redrafted) in 2011 to extend the requirements of the regulation (5). The recast-RoHS, referred to as RoHS 2) applies to electrical and electronic equipment (referred to in the directive as EEE) and any company that manufactures, imports, distributes, or acts as authorized representative for such products. If EEE products containing certain hazardous substances are sold in the EU market, the product must contain no more than the agreed upon levels of said materials (6) (7) (8).
The Who, What and How of RoHS 2
What are the “certain hazardous substances”?
The hazardous materials specified by the EU Commission and the maximum allowable levels arelisted below. The directive states that the Maximum Concentration Values (MCVs) apply to each “homogenous material” that make up the entire product. A homogenous material is one that composed of the same uniform material. For example, the metal used to solder a medical device must not contain anything over the MCV of the materials listed below (9):
|Lead (Pb)||< 1000 ppm|
|Mercury (Hg)||< 1000 ppm|
|Cadmium (Cd)||< 100 ppm|
|Hexavalent Chromium: (Cr VI)||< 1000 ppm|
|Polybrominated Biphenyls (PBB):||< 1000 ppm|
|Polybrominated Diphenyl Ethers (PBDE)||< 1000 ppm|
|Bis(2-Ethylhexyl) phthalate (DEHP)||< 1000 ppm|
|Benzyl butyl phthalate (BBP)||< 1000 ppm|
|Dibutyl phthalate (DBP)||< 1000 ppm|
|Diisobutyl phthalate (DIBP)||< 1000 ppm|
Who Must Comply
Electrical and Electronic Equipment is defined by the RoHS directive as “equipment which is dependent on electrical currents or electromagnetic fields in order to work properly and equipment for the generation, transfer and measurement of such currents and fields and designed for use with a voltage not exceeding 1000 Volts for Alternating Current and 1500 Volts for Direct Current.” (9)
If a product your company manufactures falls into one of the categories listed below, and is not specifically exempted by the directive (full list found in Annex IV of the Directive) you are responsible for being RoHS compliant (9):
- large household appliances
- small household appliances
- IT and telecommunications equipment
- consumer equipment
- lighting equipment
- electrical and electronic tools
- toys, leisure and sports equipment
- automatic dispensers
- Medical devices and monitoring and control instruments, became effective July 2014 (except active implantable devices which will be reviewed for inclusion in 2020.)
- non-industrial monitoring and control instruments
- in vitro medical devices, starting July 2016
- Industrial monitoring and control instruments, starting July 2017
- all EEE not specifically exempted, starting July 2019
How Does a Company Ensure Compliance?
As of July 1, 2006 (when RoHS I went into effect) any company that produces EEE products that that are currently in or entering the EU market must be able to demonstrate compliance with RoHS requirements (6). The effective dates are different for industrial monitoring instruments, medical devices, and in vitro devices due to the fact that they were added to the directive when RoHS II was issued.
When the RoHS was recast in 2011, it became a CE mark Directive. This means that EEE products that are not specifically exempted from the RoHS cannot be CE Marked unless they are RoHS compliant. However, notified bodies will not conduct an audit for RoHS conformity, this remains the responsibility of the EU member state (11) (8). In order to demonstrate compliance, companies must take the following steps:
- Review the design and manufacturing procedures to ensure that the EEE product does not contain anything above the allowable levels of restricted materials.
- Establish production control systems that support compliance. These should be periodically reviewed ensure that compliance is maintained.
- Create a device/product Technical File that demonstrates RoHS compliance. This file should be kept on record for 10 years.
- Prepare an EU Declaration of Conformity that includes RoHS
- Follow the RoHS label requirements:
- clearly mark the EEE with type, batch or serial number for identification
- place your name, trade name or trademark on the product and packaging
- If a manufacturer believes that a product on the market is not RoHS complaint, they must either bring the devices into compliance or withdraw or recall the device. Standard procedures such as informing the supply chain and taking corrective action as necessary must be followed (5). If this occurs manufacturers should inform the competent national authorities of the Member States for which they market the device of the non-compliance and the corrective actions taken (8).
- Provide any documentation requested by EU Competent Authorities in regards to RoHS compliance.
- Quinn, Matt. Conflict Minerals. Intertek – Managing Conflict Minerals Requirements. s.l. : MASSMedic, 2015.
- Thomas, Dynda A. and Stokes, Kate. EU Conflict Minerals Regulation — What’s Going On? CONFLICT MINERAL COMPLIANCE, ETHICAL SOURCING, NEWS AND ANALYSIS. [Online] February 17, 2016. http://www.conflictmineralslaw.com/.
- U.S. Securities and Exchange Commission. Disclosing the Use of Conflict Minerals. SEC FACT SHEET. [Online] July 29, 2014. https://www.sec.gov/News/Article/Detail/Article/1365171562058.
- PricewaterhouseCoopers LLP. Conflict minerals: What does Dodd-Frank Section 1502 mean for companies in the Medical Device Industry? . PWC. [Online] May 2013. http://www.medsc.org/pdfs/Szczesny-PwCConflictMinerals.pdf.
- National Measurement Office. RoHS 2011/65/EU Non-Complying Product Notifications and Actions Guidance. UK Government. [Online] September 2013. https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/303656/notification_guidance_for_rohs.pdf.
- RoHSGuide.com. RoHS Compliance FAQ. RoHSGuide.com. [Online] 2016. http://www.rohsguide.com/rohs-faq.htm.
- RoHS Compliance. RoHS Compliance Definition. Consumer Product Safety Act Compliance. [Online] 2015. http://www.rohscompliancedefinition.com/.
- The European Parliament and the Council of the European Union. DIRECTIVE 2011/65/EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on the restriction of the use of certain hazardous substances in electrical and electronic equipment. Official Journal of the European Union . [Online] June 8, 2011. http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2011:174:0088:0110:EN:PDF.
- BIS UK Government. ROHS REGULATIONS . Department for Innovation and Skills – UK Government. [Online] February 2011. https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/31803/11-526-rohs-regulations-government-guidance-notes.pdf.
- QNET LLC. RoHS2 DIRECTIVE 2011/65/EU What Manufacturers Need To Know And Do. Ce-mark.com. [Online] 2013. http://www.ce-mark.com/RoHS2.pdf.
- Eisenhart, Stewart. Eucomed Guidance Clarifies RoHS Compliance for Medical Device Companies. Emergo Group. [Online] June 11, 2013. http://www.emergogroup.com/blog/2013/06/eucomed-guidance-clarifies-rohs-compliance-medical-device-companies.
 Due diligence and RCOI are not part of the same process. Due diligence is conducted after a company has determined that their product contains conflict minerals sourced from countries of risk.