Medical Devices under REACH
This article was originally published in SRA
Executive Summary
Marc Bauer and Sebastian Lach report that new EU legislation on chemicals registration will have a major impact on the medical devices industry.
Marc Bauer and Sebastian Lach report that new EU legislation on chemicals registration will have a major impact on the medical devices industry.
Marc Bauer and Sebastian Lach are both lawyers at Lovells LLP in Munich, Germany.
Compliance with new European Union legislation regulating chemicals and their safe use has become a major issue for companies operating in sectors affected by the law. Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals1 - better known as REACH - entered into force on 1 June 2007. However, the most significant material provisions of the regulation entered into force more recently, on 1 June 2008.
REACH replaces about 40 European and national regulations to harmonise and improve the former legislative framework on substances in the EU. It aims mainly to protect human health and the environment from the risks that can be posed by substances. To this end, it places greater responsibility on the industry to manage risks for human health and the environment.
The legislation in the first instance may aim to regulate substances manufactured, imported or used by the chemicals industry, but products in almost all industry sectors are affected by the regulation. This article shows to what extent medical devices are affected by REACH and what requirements have to be fulfilled by medical device companies.
Significant material provisions
Currently at the centre of attention is the registration obligation for substances manufactured in, or imported into, the EU. The registration provisions stipulate that substances may only be manufactured, imported or placed on the market within the EU in quantities above one tonne per year if a (pre-) registration (preregistration for phase-in substances is principally possible between 1 June and 1 December 2008) is completed. This requirement also applies to producers or importers of articles if a substance is present in the article in quantities totalling over one tonne per year and the substance is intended to be released under normal or reasonably foreseeable conditions of use (eg a scented eraser). REACH defines “articles” as objects that are given a special shape, surface or design during production, which determines their function to a greater degree than their chemical composition.
Applicability to medical devices
REACH is applicable to all substances on their own, in preparations or in articles, unless they are exempt from the legislation. Substances in medical devices - in contrast to medicinal products are principally fully subject to REACH. Under REACH, “substance” means a chemical element and its compounds in the natural state or obtained by any manufacturing process; this includes any additive necessary to preserve its stability and any impurity deriving from the process used, but excludes any solvent that may be separated without affecting the stability of the substance or changing its composition. For substances in medical devices, only very few exemptions from specific obligations apply.
In particular, certain medical devices are exempt from the provisions of Title IV (information in the supply chain according to Articles 31 et sqq). This exemption applies to substances in devices that are invasive or used in direct physical contact with the human body in so far as community measures lay down provisions for the classification and labelling of dangerous substances that ensure the same level of information provision and protection as Directive 1999/45/EC2. Moreover, for some medical devices reduced authorisation requirements apply; the authorisation procedure (Articles 55 et sqq) is conducted by the European Commission with assistance of the European Chemicals Agency and is even stricter than the registration. The authorisation procedure will apply to substances of very high concern to be listed in Annex XIV of REACH. As regards medical devices regulated under Directive 90/385/EEC3, Directive 93/42/EEC4 or Directive 98/79/EC5 (the medical devices directives), possible risks to human health arising from the use of such substance in a medical device will not be assessed in REACH's authorisation procedure.
Consequences for medical devices
As only very limited exemptions apply, REACH has a major impact on the medical device industry. This impact will mainly be felt in research and development, as well as in manufacturing and distribution of medical devices. Specific legal problems will arise for medicinal products contained in medical devices.
Research and development
R&D activities on medical devices are principally covered by REACH. However, for certain R&D activities, REACH states exemptions from registration, authorisation or restrictions. The exemptions apply if “scientific research and development” or “product and process orientated research and development” take place.
Scientific research and development
Pursuant to Article 3(23), scientific R&D means any scientific experimentation, analysis or chemical research carried out under controlled conditions in a volume of less than one tonne per year. If preclinical and clinical trials are performed with medical devices by using the contained substances below one tonne per year in order to develop a new product or to enhance an established product, this would fall under scientific R&D under REACH. Thus, registration of such substances would not be required. The same would apply if the substance was subject to authorisation (Article 56(3)). Moreover, in this case the substance would not be subject to restrictions for manufacturing or placing on the market (Articles 67 et sqq).
Product and process orientated R&D
If substances are used in a quantity above a tonne per year to develop or enhance a medicinal product, the exemption for scientific research and development under Article 3(23) would not be applicable. However, substances used in preclinical or clinical studies above one tonne per year may benefit from the exemption under product and process orientated R&D (PPORD).
Pursuant to Article 3(22), PPORD means any scientific development related to product development or the further development of a substance, on its own, in preparations or in articles in the course of which pilot plant or production trials are used to develop the production process and/or to test the fields of application. As this definition mainly focuses on process development, it is arguable whether preclinical and clinical trials with medical devices are covered by PPORD. However, since the definition also expressly refers to “…scientific development related to product development…”, we see good arguments to conclude that preclinical and clinical trials with substances in medical devices above one tonne per year will fall under the PPORD exemption. Given that preclinical and clinical trials should be covered by PPORD in accordance with Article 3(22), the following consequences apply:
- substances used in medical devices for trial purposes can be exempt from registration in accordance with Article 9 for five years. The period can be extended for a further five years. Such an exemption requires a notification of the European Chemicals Agency (EChA); and
- Articles 56(3) sentence 2 and 67(1) sentence 3 provide for specific exemptions from authorisation or restrictions for substances used for PPORD, since those are not principally free from authorisation and restrictions. The specific scope of exemption from authorisation will be specified in Annex XIV (the final version of which has not yet been published), and from restrictions in Annex XVII.
Medical device companies should, therefore, closely investigate their R&D activities in order to assess whether they use substances that require PPORD notification or whether they comply with the specific scope of exemptions from authorisation/restrictions.
Manufacturing and distribution
Medical device companies also face additional regulatory obligations under REACH as regards manufacturing and distribution.
Manufacturing
Substances in raw material for the production of medical devices are fully subject to REACH requirements. Thus, if a medical device company manufactures substances within the EU in volumes above one tonne per year and/or imports substances into the EU in volumes above one tonne per year, it is obliged to register such substances to be allowed to continue manufacturing and/or importing. In the case of phase-in substances, the substance may be preregistered between 1 June 2008 and 1 December 2008 in order to benefit from extended deadlines for full registration. According to Article 3(20), phase-in substance means a substance that meets at least one of the following criteria:
- it is listed in the European Inventory of Existing Commercial Chemical Substances; or
- it was manufactured in the European Community, or in the countries acceding to the EU on 1 January 1995 or on 1 May 2004, but not placed on the market by the manufacturer or importer, at least once in the 15 years before the entry into force of REACH.
If a medical device company sources the raw material from within the EU, it is a downstream user. As such it has no registration obligation. However, the company should request a written confirmation that the supplier complies with its obligations under REACH (eg registration). Otherwise, it faces the risk of a supply interruption. In this case, it should be prepared to replace either the supplier or the relevant substance.
Moreover, substances in raw materials may be subject to authorisation or restrictions. These obligations can apply to manufacturers and, in contrast to registration obligations, also to mere downstream users. Medical device companies that fall into one of these groups must evaluate their raw material sourcing in order to identify potential risks for their supply. It is also necessary to ensure that medical device company suppliers comply with their obligations under REACH. The medical device company should also request a written confirmation that the supplier is in compliance with authorisation and restriction requirements under REACH.
Distribution
Medical device companies have to assess whether substances in products they distribute within the EU are subject to registration, authorisation or restrictions under REACH. They also have to evaluate whether a product can be regarded as a preparation in a container/carrier or an article under REACH.
If a medical device can be regarded as a preparation in a container/carrier (eg contact lens solution), each substance contained in the preparation has to be assessed. If the medical device company imported the medical device into the EU it would have to assess whether the product comprises substances in quantities above one tonne per year. Each substance that exceeds this threshold would have to be registered (substance impurities may be excluded). In case of phase-in substances they may be preregistered in order to benefit from extended deadlines for full registration. In cases where the medical device company merely assembles the product within the EU, no registration obligations would apply. Nevertheless, the sourced raw materials must comply with REACH (see manufacturing above).
Moreover, regardless of whether the device is produced within the EU or imported into the EU, if a substance of very high concern (Articles 57, 59(1)) listed in Annex XIV is contained in the product, an authorisation under REACH would be required. However, the authorisation procedure under REACH will not consider the risks to human health arising from the use of a substance in a medical device as they are regulated by the medical devices directives. Finally, the restrictions as set out in Articles 68 et sqq are fully applicable to medical devices (phthalates, for example) and have to be assessed before a medical device is distributed within the EU.
The majority of medical devices will fall under the definition of an article (eg a thermometer). As a consequence, registration requirements will only apply if the special prerequisites of Article 7 are fulfilled. Article 7 stipulates that a manufacturer or importer of a medical device will be required to register any substances of the device that are present in quantities totalling over one tonne per year and are intended to be released under normal or reasonably foreseeable conditions of use.
If an article comprises a substance of very high concern (Articles 57, 59(1)), the EU producer/importer will have to submit a notification to the European Chemicals Agency. This requires that the substance is present in quantities totalling over one tonne per year and is present in each article above a concentration of 0.1% weight by weight. Moreover, the restrictions as set out in Articles 68 et sqq fully apply to substances in articles (eg phthalates).
Thus, the regulatory requirements to place a medical device on the European market have become stricter. A CE-certification is no longer the only regulatory requirement that has to be fulfilled. In addition, producers or importers of medical devices may have to comply with the regulatory requirements under REACH. Otherwise, distribution - even if a CE-certification is completed - would be inadmissible under REACH and subject to national penalties.
Medicinal products in medical devices
REACH does not explicitly address medicinal products contained in medical devices (eg pain-relief patches), eg where the main effectiveness is physically achieved and the effect of the medicinal component has only supporting function. It is unclear whether the respective substances fall under the medicinal products exemption as set out in Article 2(5a). If they do not, they would share the fate of the medical device they are contained in. However, we see good grounds to conclude that the medicinal product component would still benefit from the exemption of Article 2(5a)6.
Medical devices with medicinal product components are subject to Directive 93/42/EEC. Annex 1 section 7.4 of Directive 93/42/EEC states that:
Thus, the qualification of the whole product as a medical device does not affect the qualification of the individual medicinal product component. Such a component is still subject to the requirements set out in Directive 2001/83/EC. In particular, such medicinal product components of medical devices are subject to the same assessment procedure as medicinal products on their own as regards risks for human health and the environment. The assessment under Directive 2001/83 is inter alia the root of the exemption of Article 2(5a). Thus, as the assessment under Directive 2001/83/EC still takes place, an additional REACH evaluation is not necessary. Registration, authorisation and downstream user obligations should not, therefore, apply.
Conclusion
REACH applies to medical devices. The scope of exemptions is very limited and will not eliminate the regulatory burden for medical devices companies. As regards R&D activities (preclinical and clinical studies), medical device firms may have to comply with additional regulatory requirements depending on the volumes of substances used for such activities.
The impact on manufacturing of medical devices will also be considerable. In particular, medical device companies should carefully assess to what extent they or their suppliers have to comply with regulatory requirements under REACH (eg registration) as regards manufacturing and sourcing of raw materials. In case the supplier has to comply with regulatory obligations under REACH, the medical device company should ensure access to vital production resources.
With respect to the distribution of medical devices in Europe, companies face - besides the CE-certification - additional regulatory obligations under REACH (eg registration, authorisation). The specific obligations depend on whether the medical device as such can be qualified as a preparation in a container or an article under REACH.
References
1. Regulation (EC) No 1907/2006, OJ, 30 December 2006, L396, 1-849, http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2006:396:0001:0849:EN:PDF
2. Directive 1999/45/EC relating to the classification, packaging and labelling of dangerous preparations, OJ, 30 July 1999, L200, 1-68, http://europa.eu.int/eur-lex/lex/LexUriServ/LexUriServ.do?uri=OJ:L:1999:200:0001:0068:EN:PDF
3. Directive 90/385/EEC relating to active implantable medical devices, OJ, 20 July 1990, L189, 17-36, http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:31990L0385:EN:HTML
4. Council Directive 93/42/ EEC concerning medical devices, OJ, 12 July 1993, L169, 1-43, http://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexapi!prod!CELEXnumdoc&lg=en&numdoc=31993L0042&model=guichett
5. Directive 98/79/EC on in vitro diagnostic medical devices, OJ, 7 December 1998, L331, 1-37, http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:31998L0079:EN:HTML
6. See also Wimmer in PharmR, 2008, p137 et sqq