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Under the Environmental Microscope

Reviewing the environmental and health effects of medical devices is the first step in a major regulatory overhaul of the sector. Matthew Townsend and José Cofré at Allen & Overy LLP explain the obligations that manufacturers, importers and distributors face

When the rules in the Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment (RoHS) Directive came into force on 1 July 2006, producers (manufacturers, importers or re-sellers who rebrand products) of electrical and electronic equipment (EEE), ranging from toys to electrical and electronic tools, were faced with new producer responsibility obligations designed to reduce the negative environmental impacts of EEE placed on the EU market, particularly at the end of its useful life (1).

Notable omissions from the scope of the RoHS Directive were medical devices and monitoring and control instruments, due to concerns at the time over the reliability and availability of certain substitute materials, particularly lead in solders used in safetycritical equipment. Indeed, medical devices such as EEE have always been widely distinguished from consumer electronics as being highly complex, with the consequences of product failure potentially leading to death or injury. Of further importance is the interplay between any RoHS Directive restrictions on the use of certain substances with requirements to meet specific obligations under other directives regulating medical devices, which require that high levels of performance and safety are met (2).

Notwithstanding this, the RoHS Directive ominously stated that the European Commission would present proposals for including medical devices and monitoring and control instruments within its scope in the future. After a Commission proposal in 2008, various meetings and the consideration of numerous compromise legal texts, the European Parliament and Council adopted a revised version of the RoHS Directive in May this year (the Recast), which included medical devices, as well as monitoring and control instruments within its scope. The Recast will enter into force on the 20th day following its publication in the EU Official Journal (which is expected at any time). Member states must have implemented the Recast within 18 months of its publication.

WHAT DOES THE RoHS DIRECTIVE RESTRICT?

The Directive places obligations on producers of EEE to ensure that any new EEE that is put on the EU market does not contain certain hazardous substances in excess of prescribed maximum concentrations. The prohibited hazardous substances are:
  • Lead
  • Mercury
  • Cadmium
  • Hexavalent chromium
  • Polybrominated biphenyls
  • Polybrominated diphenyl ethers
The Recast will not add any new substances to the current list (at least initially), although the Commission will continue to review and adapt the list of restricted substances according to a number of criteria. There remains, therefore, the distinct possibility that additional substances will be added to the list in the future.

KEY CHANGES UNDER THE RECAST

The Recast was developed with the stated objective of reducing the regulatory burden on businesses within the EU by improving the RoHS Directive’s “implementation, enforcement and coherence”, and with the aim of making EU business more competitive. The result is a significant overhaul of the Directive, with some important changes affecting manufacturers of EEE. There is an extension of the scope of the Directive to types of EEE which had previously not been covered by the existing RoHS Directive, the mechanism for adding to the list of restricted substances will change and the system governing applications for exemptions from the restrictions is to be refined. There will also be stricter marketing rules, as EEE will, for the first time, have to bear the CE Marking showing that it conforms with relevant standards. In addition, there will be new obligations on manufacturers to recall or withdraw products which have been placed on the market and which the manufacturer has reason to believe do not comply with the Recast. We consider some of the key changes below.

Widening the Scope
Perhaps the most visible of changes introduced by the Recast relates to the extent of equipment caught in its scope. In addition to including medical devices (including in vitro diagnostic medical devices) and monitoring and control instruments, the Recast also introduces an open scope. This means that, eventually, all EEE which are not already listed in Annex I of the Recast will be covered, unless they are specifically excluded.

The Recast also explicitly includes cables and spare parts or reused spare parts recovered from EEE placed on the market before 1 July 2006 and used in equipment put on the market before 1 July 2016 (where reuse takes place in an auditable closed loop business-to-business system, with the reuse of those parts having been notified to the consumer). This applies unless they have been used for the repair, reuse, updating or upgrading of EEE placed on the market before 1 July 2006, or of medical devices, in vitro diagnostic medical devices and monitoring and control instruments placed on the market before the dates from which they are covered by the Recast (see ‘Timing’ below).

The medical devices covered under the Recast are those as defined under the Medical Devices Directive. This includes devices that, among other things, are used for diagnosis, prevention, monitoring and investigation of disease, the anatomy or physiological processes. Similarly, the in vitro diagnostic medical devices covered under the Recast are those as defined by reference to the In vitro Diagnostic Medical Device Directive. Active implantable medical devices are not covered by the Recast.

Timing
In the case of medical devices and monitoring and control instruments, the Recast applies only to those devices which are placed on the market three years after the Recast comes into force (and in the case of in vitro diagnostic medical devices, to those which are placed on the market five years after the Recast comes into force). The open scope will take effect eight years after the Recast comes into force.

Express Exclusions
Apart from the exclusion of active implantable medical devices from the scope of the Recast, other exclusions of potential relevance to medical devices and monitoring and control instrument manufacturers and importers are:
  • Large-scale stationary industrial tools (the LSIT Exclusion)
  • Large-scale fixed installations (the LFI Exclusion)
  • Equipment designed solely for research and development which is made available on a business-tobusiness basis
  • Equipment which is specifically designed, and is to be installed, as part of another type of equipment that is excluded or does not fall within the scope of the RoHS Directive, which can only fulfil its function if it is part of that equipment, and which can be replaced only by the same specifically designed equipment
Importantly, while the LSIT Exclusion and the LFI Exclusion both existed under the RoHS Directive, the Recast provides definitions for these exclusions for the first time. The new definitions are helpful in providing greater clarity over the scope of the exclusions, but there is no new guidance or any indication yet to suggest that larger medical devices, such as radiological scanners and other diagnostic apparatus, are intended to fall within scope of the exclusions. In this regard, the LSIT Exemption is unlikely to apply to such devices in a healthcare setting given that, in order for the exclusion to apply, they are to be “used and maintained by professionals in an industrial manufacturing facility or research and development facility.”

However, whether such devices would fall under the LFI Exclusion remains to be seen. The definition of “large-scale fixed installation” covers a combination of several types of apparatus and/or other devices, which are assembled and installed by professionals, intended to be used permanently in a pre-defined and dedicated location, and de-installed by professionals. Commission guidance issued in respect of the RoHS Directive suggests that installations such as lifts or escalators would fall within this definition and emphasises that such installations will not cover those “intended to be placed on the market as a single functional or commercial unit”. No updated guidance has yet been issued in respect of the Recast, but if it were to be consistent with the current guidance, there is doubt over whether larger medical devices, such as x-ray imaging machines, would benefit from this exclusion when they are sold as single functional units.

Exemptions
Annex IV of the Recast specifies a number of applications which are exempt from the restrictions specific to medical devices (and monitoring and control instruments). The list is fairly extensive, including:
  • Lead in a large number of medical applications (including in x-ray tubes and in detectors for ionising radiation)
  • Cadmium and mercury in ionising radiation detectors
  • Lead, cadmium and mercury in infra-red light detectors
  • Cadmium in x-ray measurement filters
In addition to those exemptions already listed in the Recast, manufacturers will also be able to apply for additional exemptions from the substance restrictions. Any such exemptions granted in respect of medical devices will have a maximum validity period of seven years (although a shorter period may be specified in particular cases). After this time, the exemption will expire unless a further application for renewal is made.

While the precise mechanism for securing new exemptions is yet to be agreed, there are some key principles which will be taken into account by the Commission when considering whether to approve an application for an exemption. In broad terms, applications will only be approved if the exemption does not weaken the environmental and health protections provided for in the REACH Regulation and where the following conditions are met (3):
  • The elimination or substitution of the restricted substance is scientifically or technically impracticable
  • The reliability of substitutes is not ensured by the information contained in the exemption dossier
  • The total negative environmental, health and consumer safety effects caused by substitution are likely to outweigh the overall environmental, health and consumer safety benefits of the substitution
The Commission will also take into consideration the availability of substitutes and the socio-economic impact of substitution. These are important additional factors which should assist businesses – particularly those manufacturing medical devices – applying for exemptions.

It should also be noted that a potential substitute will be deemed to have negative socio-economic, health and safety effects under the Recast, where a notified body has already certified that the safety of a potential substitute has not been demonstrated under the relevant conformity assessment procedure in the Medical Devices Directive or the In Vitro Diagnostic Medical Device Directive.

Further Restricted Substances
There are four substances which have been put onto a ‘priority list’ for urgent assessment and possible future restriction under the Recast (4). The process by which substances are chosen for restriction will be by way of applications to a committee delegated by the European Commission, following measures which are yet to be finalised in detail. However, proposals to review and amend the list of restricted substances or group of similar substances in Annex II of the Recast will require the following factors as a minimum:
  • Precise and clear wording of the proposed restriction
  • References and scientific evidence for restriction
  • Information on the use of a substance of a group of similar substances in EEE
  • Information on detrimental effects and exposure in particular during waste EEE management operations
  • Information on possible substitutes and other alternatives, their availability and reliability
  • Justification for considering an EU-wide restriction as the most appropriate measure
  • Socio-economic assessment
A major sticking point in negotiations during the adoption of the Recast was the Commission’s proposal that the relevant parts of the REACH Regulation should replace any committee procedure agreed under the RoHS Directive and, controversially, that lists of priority and restricted substances under REACH should be automatically included within the Recast (5). A compromise was reached, which requires that decisions taken to list priority substances and to restrict them under REACH must be taken into account during a review of substance restrictions under RoHS, which is to be carried out for the first time within three years of the Recast coming into force (and periodically thereafter). This review must also use publicly available knowledge obtained from the application of REACH. However, while this suggests that decisions taken to prioritise or restrict substances under REACH will have a direct influence over Annex II of RoHS, the Recast notes that the mutually independent operation of RoHS and REACH should continue.

OBLIGATIONS TO BE MET

Manufacturers, importers and distributors face a number of obligations under the existing RoHS Directive and the Recast.

Manufacturers
The principal burdens lie with manufacturers of EEE. This includes those who re-brand a product with their own name or trademark or who modify EEE that is already on the market in such a way that compliance with applicable requirements may be affected.

Manufacturers must ensure that all EEE is designed and manufactured in compliance with the Recast and that procedures are in place for series production to remain in conformity. For the first time, there is a requirement to draft an EC declaration of conformity in respect of the products. All EEE must now carry the CE marking in order to demonstrate compliance, and the manufacturer must maintain the documentation for a period of 10 years after the EEE has been placed on the market. Products can be fixed with the CE marking provided that manufacturers have drawn up required technical documentation and carried out the conformity assessment procedures set out in the EU Decision on the Marketing of Products (6). If EEE already undergoes a conformity assessment procedure under other applicable EU legislation which is at least as stringent as that in the Decision on the Marketing of Products, then compliance with the Recast (and in particular, that products do not contain any RoHS restricted substances) may be demonstrated through that single conformity assessment procedure. In this regard, medical devices are already subject to stringent conformity assessment procedures and, accordingly, the documentation concerning RoHS compliance should be able to form part of a single procedure.

Manufacturers must carry out sample testing of EEE, investigate and keep a register of non-conforming EEE and product recalls, and keep distributors informed of any such events. Ensuring the ongoing compliance of EEE is a key obligation for a manufacturer. Where a manufacturer considers, or has reason to believe that EEE is not compliant with the Recast, they must take corrective action immediately, or withdraw or recall the product from the market. They must then immediately inform the competent national authorities of the member states in which the EEE has been made available of the recall or withdrawal of the EEE, giving details about the noncompliance and any corrective measures.

Importers
Importers must only place RoHS compliant products onto the EU market. Accordingly, they must ensure, when buying products from non-EU manufacturers, that the products comply with the new requirements. Under the existing RoHS Directive, it has been a challenge for importers that have not manufactured the imported product to secure the necessary comfort from the manufacturer that the EEE complies with the RoHS requirements. Importers, in a similar vein to manufacturers, also have a number of testing and administrative demands placed on them by the Recast, for example ensuring that their name and a contact address are marked on each piece of EEE (or where not possible, on the packaging), maintaining a register of all noncompliant EEE and EEE recalls, and maintaining copies of the EU declaration of conformity for 10 years.

Distributors
When making EEE available on the market distributors must ensure that they act with due care in relation to RoHS requirements, particularly by verifying that the EEE has the CE marking and is accompanied by required documents in a language which is understood by consumers and other endusers in the member state in which the EEE is to be made available on the market. They must also act with due care to ensure that both manufacturers and importers have ensured that their EEE bears a type, batch or serial number or other element allowing its identification (or, if the size or nature of the EEE does not allow this, that the required information is provided on accompanying documentation). In addition, care should be taken that manufacturers and importers have indicated their name, registered trade name or registered trademark and a single contact address at which the manufacturer can be contacted. Where a distributor considers or has reason to believe that EEE is not in conformity with the Recast, it must not make that EEE available on the market until it has been brought into conformity. The distributor must inform the manufacturer or importer as well as the market surveillance authorities where this is the case.

Enforcement and Penalties The Recast is silent on the procedures each member state should take for the enforcement of the Directive. In the UK, for example, enforcement of the regulations implementing the current RoHS Directive is taken on by the National Weights and Measures Laboratory (NWML). The NWML has extensive powers in relation to RoHS investigations, including making test purchases of products, entering premises for the purposes of gathering evidence, taking or requiring samples to be produced and requiring any person to cooperate in obtaining any evidence.

When the NWML reasonably suspects an infringement of the implementing regulations, it may issue a compliance notice, requiring the producer to comply within a certain period of time. Failure to do so may lead to the issuance of an enforcement notice which will specify the infringing product, and demand compliance within no less than 21 days. Enforcement notices may require that the identified goods are withdrawn from the market, or may prevent the producer from putting them on the market. Failure to comply can lead to prosecution.

CHANGES ON THE HORIZON

The changes introduced by the Recast come at a time when the medical devices sector is facing the prospect of a major regulatory overhaul. The European Commission is currently looking at proposals to update the framework for bringing medical devices to the European market, with possible changes being made to the Medical Devices Directive, the In Vitro Diagnostic Medical Device Directive and the Active Implantable Medical Devices Directive. Among other things, this may lead to changes to the CE conformity procedure (as applied to medical devices) and the introduction of a new European agency with regulatory responsibility for the sector.

The Commission recently hosted a high level conference of industry bodies at which possible approaches were discussed and we await to see the detailed form of the changes. What is clear, however, is that much greater focus is being given to the environmental and health impacts of medical devices and the inclusion of these products into the RoHS regime is seen by many as only the first step down that road.

References
  1. Directive 2002/95/EC on the Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment
  2. Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (Medical Devices Directive), Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the member states relating to active implantable medical devices (Active Implantable Medical Devices Directive) and Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices (In Vitro Diagnostic Medical Device Directive)
  3. Regulation (EC) No 1907/2006 concerning the registration, evaluation, authorisation and restriction of chemicals
  4. HBCDD, DEHP, BBP and DBP
  5. Regulation (EC) No 1907/2006 concerning the registration, evaluation, authorisation and restriction of chemicals
  6. Decision No 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


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Matthew Townsend is a partner and head of the London environmental law group at Allen & Overy. He advises on environmental and health and safety matters across a broad range of corporate and real estate transactions, projects and finance-related matters. He has particular experience in product stewardship, waste management, producer responsibility for recycling and the regulation of chemicals (including REACH). Matt also has wide experience of advising clients on the impact of the European Union directives on WEEE and RoHS. Email: matthew.townsend@allenovery.com

José Cofre is a Senior Associate in the London environmental law group at Allen & Overy. He advises clients on the impact of REACH and chemicals regulation and the EU directives on WEEE and RoHS. José specialises in REACH, product stewardship and other environment, clean energy and climate change matters across a variety of sectors. José has advised numerous multinational companies and global manufacturing organisations on product stewardship issues such as Ineos, Rio Tinto, Shell, Boeing, Koch Industries, Anglo American and RWE Supply & Trading. Email: jose.cofre@allenovery.com
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