New RoHS Obligations for Electronic Medical Devices

New RoHS Obligations for Electronic Medical Devices

Electronic medical device manufacturers, authorized representatives, importers and distributors active in the European Union soon willhave to pay even more attention to what goes into the products they make. There is now another environmental requirement to consider.

In June, the European Parliament issued a recast of the Restriction of the Use of Certain Hazardous Substances (RoHS) in Electrical and Electronic Equipment Directive (Directive 2011/65/EU) that now includes medical devices and in vitro devices (IVDs) among the equipment under its purview. The RoHS directive now boasts its own listing of categories (Annex I) subject to the directive. The RoHS directive previously had linked to the Waste Electrical and Electronic Equipment (WEEE) Directive (Directive 2002/96/EC) and the categories of products subject to RoHS delineated within the WEEE directive.

Annex II of the RoHS directive bans electronic equipment with maximum concentration values exceeding 0.1 percent of lead, mercury, cadmium, hexavalent chromium, polybrominated biphenyls or polybrominated diphenyl ethers from entering the EU market. European Union parliamentarians recast the RoHS directive to minimize legal disparities between member states in terms of restrictions on hazardous materials in electrical products; without a more uniform RoHS approach, trade barriers and competitive distortions could arise within the EU marketplace.

“It therefore appears necessary to lay down rules in this field and to contribute to the protection of human health and the environmentally sound recovery and disposal of waste EEE (electrical and electronic equipment),” the new directive states. The recast directive also is intended to encourage manufacturers to use safer materials in place of restricted substances.

Interestingly, while the RoHS directive is not part of the EU’s “new approach” directive, the recast RoHS directive requires CE marking affixed to the product to demonstrate compliance and defines the roles and responsibilities of the key economic operators: manufacturers, importers and distributors.

Compliance Timelines

Medical device firms have some time, however, to establish full compliance with the directive. EU member states must complete transposition of the directive into national legislation by Jan. 2, 2013; medical devices commercialized before July 22, 2014, and IVDs commercialized before July 22, 2016, must comply with the RoHS Directive by July 22, 2019. Makers of active implantable medical devices get a reprieve because their products are exempted altogether from the new requirements.

On the other hand, new devices brought to market after July 22, 2014, as well as new IVDs commercialized after July 22, 2016, will need to comply with the RoHS directive as soon as they enter the EU market.

Compliance Requirements

The directive lays out specific compliance requirements for manufacturers, authorized representatives, importers and distributors of products with materials falling under the scope of RoHS. Compliance is demonstrated for electrical and electronic equipment (EEE) when the manufacturer affixes CE marking either to the product itself or its label. If the device required notified body involvement, only one CE marking with the notified body’s four-digit number would be required, provided the product is compliant to the RoHS.

Manufacturers marketing electronic medical devices in the EU are the most substantially impacted in terms of compliance requirements going forward:

• Ensuring that their products comply with Article 4 of the directive, whichstipulates maximum concentration limits of listed hazardous materials;

• Preparing required technical documentation and abiding by internal production control procedures in accordance with Annex II module A of Decision 768/2008/EC—in other words, self-certification;

• Preparing Declaration of Conformity and affixing CE Marking on finished products once compliance has been demonstrated, which means that the manufacturer first confirms conformity to Annex II of the RoHS directive and then prepares a single technical file and EC Declaration of Conformity according to Medical Devices Directive (or In Vitro Diagnostic Devices Directive) conformity assessment procedures;

• Keeping technical documentation and Declaration of Conformity on file for 10 years following commercialization of products;

• Ensuring procedures are in place to maintain the conformity of the series production process;

• Registering all non-conforming EEE and product recalls, and informing distributors of this data;

• Ensuring that products bear type, batch or serial numbers for identification;

• Indicating name, registered trade name or registered trademark and contact address on their products or on documents accompanying their products;

• Ensuring that immediate corrective measures are taken in the event of product nonconformity, or that nonconforming products are withdrawn or recalled, and informing competent national authorities of noncompliance information; and

• Providing all appropriate information to demonstrate EEE conformity upon request from a national authority.

Authorized Representatives

Medical device manufacturers may rely on their authorized representatives in the European Union to meet some of these pending requirements. While ensuring EEE compliance and preparation of technical documentation must be addressed solely by manufacturers, authorized representatives may be mandated to maintain Declaration of Conformity and technical documentation on file for 10-year periods; provide product and Declaration of Conformity information to competent national authorities upon request; and cooperate with national authorities in any effort to ensure RoHS compliance on behalf of manufacturers they represent.

Electronic Device Importers

The operations of electronic medical device importers also fall under the scope of the RoHS directive as well. Importers are required to ensure that they place only directive-compliant products on the EU market, and that manufacturers of those products have conducted appropriate conformity assessments, prepared required technical documentation and that those products bear CE marking.

Importers also must verify that the manufacturers they represent have properly registered non-conforming products and recalls, and that products they import to the EU have appropriate type, batch or serial numbers. As with labeling requirements for the manufacturer, the importer’s name and contact information should be included on the EEE itself or on its packaging or accompanying documentation.

Reporting and record-keeping requirements for importers under the new directive are significant. In the event that an importer suspects an EEE is not in conformity with the RoHS directive’s Article 4 or other sections, that importer is obligated to keep that EEE from entering the market until any nonconformity issues have been resolved. The importer also must notify both the manufacturer and appropriate market surveillance entities in such instances. Furthermore, importers must register all instances of EEE noncompliance issues and recalls, as well as provide such information to distributors. If suspecting that a nonconforming EEE has made it into the EU market, an importer must either take action to bring that product back into conformity or have it withdrawn or recalled; relevant national competent authorities also should be notified as soon as possible.

Distributors

Finally, distributors also face new requirements under the RoHS recast. First, distributors of EEEs must verify that products have CE marking, and that manufacturers and importers of those products are in compliance with the RoHS directive.

Distributors also must take all steps necessary to address suspected Article 4 nonconformance and notify manufacturers, importers and market surveillance authorities as soon as possible; distributors are responsible for taking corrective actions in cases where EEEs they distribute have fallen into nonconformance.

Enforcement: Work in Progress

Individual EU member states will bear responsibility for enforcing Annex II requirements of the RoHS directive, and must have transposed the directive into their legislative frameworks by Jan. 2, 2013.
Exactly how enforcement will be carried out, however, remains to beaddressed. Article 23 of the directivemandates only that penalties for noncompliance issued by member states be “effective, proportionate and dissuasive,” leaving specifics to individual governments to decide. Based on recent discussions Emergo Group has had with notified bodies, these agencies have yet to develop a formal process for verifying RoHS compliance among their clients; however, there is no doubt that notified bodies believe compliance needs to be verified.

Stewart Eisenhart is regulatory editor and Evangeline Loh, Ph.D., RAC, is vice president of regulatory affairs for Emergo Group, an international medical device consulting firm providing regulatory, quality assurance and distribution consulting services. Evangeline can be reached at [email protected].