Product-based chemical regulation in the European Union continues to change at a rapid rate. As this article will explain, companies and consultants need to make sure that they are not caught off-guard by what can appear to be seemingly unrelated regulation, as exemplified by “REACH” and “RoHS.” Interactions between these regulations can have a potentially large impact on medical devices.
The first example concerns the EU Regulation for the Registration, Evaluation and Authorisation of Chemicals (REACH). Under this comprehensive legislation, chemical substances used during the manufacture of medical devices in the European Economic Area (EEA) will usually need to be registered with the newly created European Chemicals Agency (ECHA). Downstream users of the chemical substances in the EEA must ensure that registrations cover the manufacturing application, or conduct their own safety assessment.
Under REACH, “substances of very high concern” (SVHC) are identified and listed by ECHA, for eventual authorisation. Although the use of a SVHC for the manufacture of a medical device is exempt from authorisation, general obligations for communicating the presence of any SVHC at or above 0.1% weight/weight can still apply. These communication obligations can include responding to consumer requests for such information within 45 days.
There are three particular challenges with regards to communicating SVHCs: (1) the list of SVHCs is periodically updated, such as every six months; (2) the list of SVHCs could potentially be quite long, nearing several hundred substances; and (3) there is disagreement between regulatory authorities on how to determine the 0.1% w/w threshold.
Consequently, REACH is forcing companies to be proactive in setting product specifications and requiring declarations, as well as adopting internal policies on regulatory interpretation.
Implications of REACH for Medical Devices
Generating data on the intrinsic properties of chemical substances is the primary objective of the registration process under REACH. Such information on the potential for hazards to human health can prove critical to safety assessments of medical devices, in particular with regards to toxicological evaluations of extractables and leachables.
Obligations for generating toxicological data does however, reside on manufacturers and importers of chemical products, as raw materials, such as solvents, masterbatches, and additives. A medical device manufacturer that sources chemical products from within the EEA does not register itself. Manufacturers outside the EEA are outside the regulatory scope, but importers will need to ensure compliance, unless there is adequate coverage through an Only Representative.
REACH requirements and timelines are highly dependent on tonnage. Substances below 1 tonne per year are not subject to registration and have limited requirements under other REACH processes.
The type of materials being used also determines scope of regulatory impact. The registration process does not apply to the use of materials that have been given a physical form other than a powder, pellet, or liquid. For finished articles, these are exempt from an Authorisation process, as well as the use of substances in manufacturing medical devices. That said, there is still an over-arching restriction process where chemical-specific bans can be effectuated, that can potentially cover all product types.
The EU Directive on the Restriction of Hazardous Substances (RoHS) covers electrical and electronic equipment. Until recently, medical devices were outside the scope of the legislation.
The extension of RoHS to include medical devices, which may also be classed as electrical or electronic equipment, was adopted at the EU level on 8 June 2011. However, active implantable medical devices remain completely outside the scope of the legislation and RoHS allows for case-specific exemptions. The most recent EU Directive contains an Annex that is dedicated to specific-cases for medical devices.
Timelines for implementation are progressive. Basically, meeting the requirements of RoHS apply to relevant medical devices and monitoring and control instruments placed on the market from 22 July 2014 and relevant in vitro diagnostic medical devices placed on the market from 22 July 2016. Since the timeline for the development of medical devices can be a number of years, medical device manufacturers need to carefully consider the impact of RoHS to their product and act very quickly if necessary.
Implications of RoHS for Medical Devices
To date, RoHS only regulates the chemical content of lead, mercury, cadmium, hexavalent chromium, polybrominated biphenyls, and polybrominated diphenyl ethers. There are, however, reoccurring discussions on the possible inclusion of a wider set of substances, which are hazardous to human health and/or the environment.
A manufacturer of a medical device will need to review its product portfolio, to establish the extent that its products fall within the regulatory scope of RoHS. As a second step, a company needs to gain a detailed understanding of the regulatory requirements in terms of the component parts that must be assessed in terms of the content of the restricted chemical substances. Based on experience with implementing RoHS in other industry sectors, it is advisable to start now.
Compliance with European legislation requires continual monitoring and tracking. In addition to meeting requirements under the EU Medical Devices Directives and the corresponding technical standards, legislation in other areas can impact the selection and evaluation of materials used for manufacturing. There is some good news, in that the levels for REACH SVHCs and RoHS at 0.1%, regardless as to whether at product or component level, are within easy analytical detection.
Fundamentally, regulatory requirements need to be integrated with a company’s management system. Managing change is the skill that then enables a company to successfully identify and control the knock-on impacts that can result. As change is inevitable, change management throughout the entire supply chain can be critical.
For further information or to contact the authors, please e-mail [email protected]. Smithers Viscient, formerly Smithers Springborn, is a global Contract Research Organisation (CRO) providing testing and regulatory services for the crop protection, pharmaceutical, industrial chemical, and the consumer and household product industries. Smithers Rapra provides a comprehensive independent service covering, testing, analysis, processing, and research for the polymer industry and industries using plastics and rubber in any component, product, or production process.
This article was written by Dr. Steffen Erler, Smithers Viscient, and Dr. Andrew Feilden, Smithers Rapra.