Application of new EU rules concerning restrictions of hazardous substances (RoHS) to medical devices
April 2014 | EXPERT BRIEFING | SECTOR ANALYSIS
The new European Union (EU) RoHS Directive (Directive 2011/65/EU of the European Parliament and of the Council of 8 June 2011 on the restriction of the use of certain hazardous substances in electrical and electronic equipment), commonly referred to as ‘RoHS 2 Directive’, will apply to medical devices in the EU from 22 July 2014. As part of the EU’s waste management legislation, the RoHS 2 Directive will, with some limited exceptions, prohibit the use of a number of substances in medical devices and will impose additional obligations on medical devices manufacturers.
Restriction on use in medical devices of specific substance from 22 July 2014
RoHS 2 will ban the use of lead, mercury, cadmium, hexavalent chromium, polybrominated biphenyls (PBB) and polybrominated diphenyl ethers (PBDE) in medical devices. As a consequence of RoHS 2, the use of these substances will be prohibited in medical devices from 22 July 2014 and in in vitro diagnostic medical devices from 22 July 2016.
As the complete elimination of these substances is not always feasible, the Directive includes a tolerance of 0.01 percent for cadmium and a tolerance of 0.1 percent for the other five substances.
Active implantable medical devices currently fall outside the scope of the RoHS 2 Directive. This is largely due to the fact that the European Commission’s risk assessment concluded that a high number of these products may need to be withdrawn from the market if they were to fall within the scope of RoHS 2 Directive. For some of these products, it may be technically impossible to find a substitute for the restricted substances. The European Commission does, however, plan to review the status of active implantable medical devices in 2020 with a view to their possible inclusion within the scope of the RoHS 2 Directive.
General and specific exemptions
The RoHS 2 Directive includes a number of general and specific exemptions from the prohibition on the use of banned substances. These exemptions, which will be valid for a maximum period of seven years for medical devices, are listed in Annex III and Annex IV to the RoHS 2 Directive.
Annex III provides a number of general exemptions from the RoHS 2 Directive for all electrical and electronic equipment that falls within the Directive’s scope, including medical devices. The Annex contains a list of products containing prohibited substances that may be exempt from the restrictions on the use of these substances.
As an illustration, manufacturers of white glasses containing lead used for optical applications will be able to benefit from the exemption laid down in Annex III, Section 13(a) of the RoHS 2 Directive. These manufacturers will be permitted to continue to market their medical devices in the EU after 22 July 2014 and for a maximum period of seven years from this date.
Annex IV includes exemptions for specific medical devices in which prohibited substances may continue to be used.
As an illustration, manufacturers of portable emergency defibrillators will be able to benefit from the exemption laid down in Annex IV, Section 17 of the RoHS 2 Directive. They will not be required to comply with the restriction on use of lead in solders in portable emergency defibrillators. These manufacturers can continue to market their medical devices in the EU after 22 July 2014 and for a maximum period of seven years from this date.
Consequences for medical devices manufacturers
From 22 July 2014, manufacturers will be permitted to market medical devices falling within the scope of application of the RoHS 2 Directive in the EU only if they have fulfilled the requirements laid down in the RoHS 2 Directive.
Article 7 of the Directive provides that, when placing medical devices on the EU market from this date, manufacturers must ensure that their products have been designed and manufactured in accordance with the requirements set out in Article 4 of the Directive. This means that medical devices that fall within the scope of application of the RoHS 2 Directive must not contain the restricted substances listed in Annex II of the RoHS 2 Directive or, must only contain these restricted substances to the maximum concentration value by weight in homogeneous materials specified in this Annex.
Article 7 of the RoHS 2 Directive also requires manufacturers to draw up technical documentation that would permit the assessment of the conformity of the product with relevant requirements of the RoHS 2 Directive and to carry out the conformity assessment procedure (internal production control) that reflects the obligations laid down in Module A of Annex II to Decision 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a common framework for the marketing of products and repealing Council Decision 93/465/EEC, or have this carried out by a third party.
Manufacturers will also be required to draw up an EU Declaration of Conformity affirming compliance with the obligations provided in the RoHS 2 Directive. It will be possible for manufacturers to prepare a single Declaration of Conformity to declare that their products comply with both the Essential Requirements laid down in Annex I to the Medical Devices Directive (Council Directive 93/42/EEC of 14 June 1993 concerning medical devices) or Annex I to In Vitro Diagnostic Medical Devices Directive (Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices) and with the requirements of the RoHS 2 Directive.
Finally, Article 7 of the RoHS 2 Directive also provides that manufacturers must affix the CE mark to the finished products to demonstrate compliance with the obligations provided in the RoHS 2 Directive.
A single CE mark demonstrating compliance with the Medical Devices Directive or the In Vitro Diagnostic Medical Devices Directive, the RoHS 2 Directive, and any other Directives which impose CE marking as an indication of compliance with their provisions will be sufficient.
The RoHS 2 Directive also imposes new obligations on importers and distributors of medical devices in the EU. Importers and distributors will be required to inform the competent authorities of the EU Member States when medical devices which are not compliant with the substance restrictions imposed by the RoHS 2 Directive are withdrawn or recalled from the EU market.
Importers will also be required to mark all compliant medical devices with their name or trade mark and contact address. This labelling requirement will apply in addition to the labelling requirements laid down in Annex I to the Medical Devices Directive or the In Vitro Diagnostic Medical Devices Directive.
Excluded activity: the repair of medical devices
Manufacturers who undertake or subcontract repair activities for medical devices placed on the EU market before 22 July 2014 do not need to comply with the requirements imposed by the RoHS 2 Directive in relation to these devices. This is because medical devices that have been ‘repaired’ are not considered to constitute new devices falling within the scope of application of the RoHS 2 Directive. Repair activities generally include activities intended for the maintenance, reconditioning or restoration of a medical device to correct working order, after it has either broken down or stopped working properly.
Moreover, the spare parts used for the repair of such devices will not be subject to the substance restrictions imposed by the RoHS 2 Directive until 22 July 2019. From that date, manufacturers will be required to use spare parts which comply with the substance restrictions imposed by the RoHS 2 Directive for the repair of their customers’ devices even if the devices which are repaired were placed on the EU market before 22 July 2014 and were not RoHS 2 compliant.
Manufacturers should, however, be aware that medical devices that are considered to be ‘fully refurbished’ will fall within the scope of application of the RoHS 2 Directive. These medical devices will be considered new medical devices and regulated as such.
Although applicable laws in the EU do not include a definition of what constitutes a fully refurbished medical device, the Co-ordination of Notified Bodies Medical Devices (NB-MED) has prepared a guidance document: NB-MED/2.1/Rec5 “Placing on the market of fully refurbished medical devices”. This document provides that “full refurbishment occurs when a device is completely rebuilt or made as new from used devices and is assigned a new useful life”.
Section 4(1) of the NB-MED/2.1/Rec5 lists the activities that must be conducted in order to consider a medical device as fully refurbished. These activities are: stripping into component parts or sub-assemblies; checking their suitability for reuse; replacement of components/sub-assemblies not suitable for reuse; assembly of the reclaimed and/or replacement components/subassemblies; testing of the assembled device against either original or revised release criteria; and the identification of the ‘fully refurbished’ device by appropriate means.
In a few weeks, the RoHS 2 Directive will be applicable to medical devices marketed in the EU. It is not too late for manufacturers to determine if their products fall within the scope of one or more of the exemptions provided in Annexes III and IV of the RoHS 2 Directive. Unless one of these exemptions applies to their products medical devices manufacturers will, from 22 July 2014, be permitted to market only medical devices that comply with the provisions of the RoHS 2 Directive in the EU.
Elisabethann Wright is a partner and Fabien Roy is an associate at Hogan Lovells International LLP. Ms Wright can be contacted on +32 2 505 09 26 or by email: email@example.com. Mr Roy can be contacted on +32 2 505 0970 or by email: firstname.lastname@example.org.
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Elisabethann Wright and Fabien Roy
Hogan Lovells International LLP