It’s official: the RoHS recast brings medical devices within the scope of the directive starting in July 2014. There are, however, exemptions and new procedures that will have a specific impact on medtech manufacturers.
Directive 2002/95/EC on the Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment (RoHS) came into force on 1 July 2006. The directive requires manufacturers, importers and resellers of electrical and electronic equipment (EEE) ranging from toys to electrical tools to adhere to new obligations designed to reduce the perceived environmental impact of EEE placed on the European market.
The RoHS directive did not cover medical devices (and monitoring and control instruments) because of concerns over the reliability and availability of certain substitute materials. Medical devices as EEE are—and have been—dealt with separately because of their relative complexity and the very serious consequences of product failure. RoHS-related restrictions on the use of certain substances combined with requirements for medical devices to meet high levels of performance and safety under other directives have also delayed their inclusion.
Despite this, medical devices and monitoring and control instruments had always been targeted for inclusion within the scope of RoHS. After a European Commission proposal in 2008, various meetings and the consideration of numerous compromise legal texts, the European Parliament and Council adopted a new RoHS Directive in May 2011 (the recast), which finally brought medical devices and monitoring and control instruments within its scope. The recast entered into force on 21 July 2011 and member states have until 2 January 2013 to implement it. The result for manufacturers of medical devices is that new substance restrictions will apply to their products and they will have to comply with EU rules on the CE marking of products caught by the new regime.
Substance restrictions under the RoHS directive
The RoHS directive places obligations on manufacturers of EEE to ensure that new EEE 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 and polybrominated diphenyl ethers.
The new directive, at least initially, does not add any new substances to the current list. However, the Commission will continue to review and adapt the list of restricted substances according to a number of criteria. This is an area of some controversy, given the overlap with the restrictions on hazardous substances under regulation EC 1907/2006 on the registration, evaluation, authorisation and restriction of chemical substances (REACH).
Key changes under the recast
The recast is intended to reduce the regulatory burden on businesses within the European Union by improving the RoHS directive’s “implementation, enforcement and coherence.” The result is a significant overhaul of the earlier directive with some important changes affecting manufacturers of EEE. In particular, there is an extension of the regime’s scope to types of EEE that previously had not been covered. Also, the mechanism for adding to the list of restricted substances will change. For the first time, EEE will have to bear the CE marking, showing that it conforms to relevant standards. In addition, there will be new obligations on manufacturers to recall or withdraw products that have been placed on the market and that the manufacturer has reason to believe do not comply with the recast.
Perhaps the most notable change introduced by the recast is the widening of types of equipment caught in its scope. In addition to medical devices (including IVD products) and monitoring and control instruments, the recast also introduces an open scope of products that will be caught (rather than having a list of products caught). This means that, eventually, all EEE that is not already covered by categories 1 to 10 of Annex I of the recast will be caught, unless it is specifically excluded. Categories 1 to 10 are the types of EEE previously listed under the existing RoHS directive plus medical devices and monitoring and control instruments. This widening of scope will not, however, apply immediately.
Notably, the recast covers certain cables and spare parts and 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.
The medical devices covered under the recast are those as defined under Directive 93/42/EEC (the Medical Devices Directive): devices that are used for diagnosis, prevention, monitoring and investigation of disease, the anatomy or physiological processes. Similarly, IVD devices covered are those as defined by reference to Directive 98/79/EC (In Vitro Diagnostic Medical Device Directive). Active implantable medical devices are not covered by the recast.
The recast also introduces a new definition of EEE, which is equipment-“dependent” on electric currents or electromagnetic fields “to fulfill at least one intended function.” This will cover products that may have a number of different purposes and/or intended uses.
There is a phased approach to the application of the new requirements to medical devices. The restrictions apply only to devices placed on the market from 22 July 2014 (and to IVD products placed on the market from 22 July 2016).
Apart from active implantable medical devices, other exclusions from the scope of the recast that may have relevance to manufacturers and importers of medical devices and monitoring and control instruments are:
Although the LSIT and LFI exclusions both existed under the first RoHS directive, the recast defines these exclusions for the first time. The new definitions are helpful in providing greater clarity over the scope of the exclusions. There is no new guidance or indication to suggest that larger medical devices such as radiological scanners and other diagnostic systems are intended to be caught within the scope of the exclusions.
The definition of “large-scale fixed installation” covers a combination of several types of apparatuses and/or other devices, which are assembled and installed by professionals, intended to be used permanently in a predefined and dedicated location and removed by professionals. European Commission guidance on the RoHS directive suggests that installations such as lifts or escalators would fall within this definition and, therefore, it provides a useful insight into what is intended by the LFI exclusion. No updated guidance has been issued yet in respect of the recast but, if it were to be consistent with current guidance, there is doubt over whether larger medical devices, such as x-ray imaging machines, where they are sold as single functional units, would benefit from this exclusion.
Annex IV of the recast specifies a number of exemptions from the restrictions concerning medical devices (and monitoring and control instruments). The list is fairly extensive and includes:
In addition to exemptions already listed in the recast, of particular importance to manufacturers is the ability to apply for additional exemptions from 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 that 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:
The Commission will also take into consideration the availability of substitutes and socio-economic impact of substitution when considering whether to grant an exemption (and its duration).
Any work or research already carried out by manufacturers on identifying possible substitutes under the Medical Devices Directive will be relevant. A potential substitute will be deemed to have negative socio-economic, health and safety impacts 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 device or IVD directive. Manufacturers, therefore, should ensure that all technical assessments compiled under those directives are available and referenced for RoHS purposes.
Further restricted substances?
Four substances—HBCDD, DEHP, BBP and DBP—have been put on a priority list for urgent assessment and possible future restriction under the recast. Substances are chosen for restriction by way of application to a committee with functions delegated by the European Commission. However, proposals to review and amend the list of restricted substances or group of similar substances in Annex II of the recast will require, as a minimum, the following:
A major sticking point in negotiations during adoption of the recast was the Commission’s proposal that relevant parts of the REACH regulation should replace a 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. A compromise was reached, requiring that decisions taken to list priority substances and 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 also must use publicly available knowledge obtained from the application of REACH.
Obligations on manufacturers
The principal burdens under the existing RoHS directive and the recast lie with manufacturers of EEE. This includes those who rebrand 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 must ensure 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 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 carry the CE mark provided that manufacturers have drawn up the required technical documentation and carried out the conformity assessment procedures set out in EU Decision No. 768/2008/EC on the marketing of products. If EEE already undergoes a conformity assessment procedure under other applicable EU legislation that is at least as stringent as the decision on the marketing of products, then compliance with the recast 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 nonconforming EEE and product recalls, and keep distributors informed of any such events. Ensuring the ongoing compliance of EEE is a key obligation for manufacturers. Where manufacturers consider, or have reason to believe, that EEE is not compliant, they must take corrective action immediately, or withdraw or recall the product from the market. They must then immediately inform the Competent Authorities of the member states in which the EEE has been made available of the recall or withdrawal, giving details about noncompliance and any corrective measures.
Notable obligations of importers and distributors
In addition to knowing the obligations that are imposed directly on them, manufacturers must be cognisant of the requirements imposed on importers and distributors under the recast. Importers also must place only RoHS-compliant products on the EU market. Accordingly, they must ensure that the products comply with the new requirements, particularly when buying products from manufacturers that are not based in the European Union.
Historically, it has been a challenge for importers (who have not themselves manufactured the imported product) to secure the necessary comfort from the manufacturer that the EEE complies with RoHS requirements. To assist importers to satisfy any concerns, manufacturers of medical devices will have to enter into a dialogue with, and supply sufficient information to, importers so as to demonstrate that they are in compliance with applicable procedures. Importers, in a similar vein to manufacturers, also have a number of testing and administrative demands placed on them by the recast, such as the requirement to have their name and a contact address marked on each piece of EEE (or, where not possible, on the packaging).
When making EEE available on the market, distributors must 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 that is understood by consumers and other end users. 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. If the size or nature of the EEE does not allow this, the required information should be provided on accompanying documentation. Accordingly, manufacturers will need to maintain and supply sufficient evidence to meet the inevitable demands of importers and distributors that EEE is manufactured in accordance with RoHS. In addition, manufacturers must have indicated their company name, registered trade name or registered trademark and a single contact address, and distributors must confirm this information is in place. Where a distributor considers, or has reason to believe, that EEE is not in compliance, it should not make the products available on the market until they have been brought into conformity. The distributor must inform the manufacturer or importer as well as the market surveillance authorities where this is the case.
Other changes on the horizon
Changes introduced by the recast come at a time when the medical device 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 device, IVD and active implantables directives). Amongst other things, this may lead to changes to the CE conformity procedure and the introduction of a new European agency with regulatory responsibility for the sector. Earlier this year, the Commission hosted a high level conference of industry bodies at which possible approaches were discussed and we await to see the detailed form of any proposed changes. What is clear, however, is that much greater focus is being given to the environmental and health impacts of medical devices. The inclusion of these products in the RoHS regime is seen by many as only the first step down that road.
is Partner and
is Senior Associate, Environmental Law Group, at Allen & Overy LLP, One Bishops Square, London E1 6AD, UK
tel. +44 20 3088 0000