par Vlad Titerlea,
Doctorant en droit à l’Université de Strasbourg
Medical devices encompass a large range of products. There are an estimated 2 million different kinds of medical devices on the world market, categorized into more than 7000 generic devices groups by the WHO. Fostering sustainability among such a variety of the same general class of products may prove to be a daunting task.
For readers who are unfamiliar with the topic of medical devices a brief reminder of what defines them might be necessary. Medical devices are health products which are used for a medical purpose. More precisely, a medical device can be any instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination to determine a health condition. The intended medical purpose of a medical device may refer to one or more steps of a complete care circle: prevention, diagnosis, treatment, monitoring, alleviation, prediction. The terms of the definition seem fairly broad, which enables the inclusion of many products while sometimes making difficult to dissociate medical devices from other medicinal products, especially when a product is composed of any combination of a device and a drug.
To simplify, medical devices tend to fall into two main categories: (general) medical devices and in vitro diagnostic medical devices (IVDs). Examples of medical devices include sticking plasters, contact lenses, X-ray machines, pacemakers, breast implants, software apps and hip replacements, condoms. IVDs are used to perform tests on human body samples. Examples of IVDs include genetic tests, HIV blood tests, pregnancy tests and blood sugar monitoring systems for diabetics. Thus medical devices (IVDs included) provide solutions for many healthcare issues and are a source of both high expectations and concerns for many patients and users. For the purpose of this paper and unless a specification is needed, the term “medical device” will refer to both (general) medical devices and in vitro medical devices.
Economically and scientifically, the European Union’s medical devices sector constitutes a dynamic, competitive and thriving market. Small and medium-sized enterprises (SMEs) dominate the economic landscape which underscores that the driving forces of innovation in the EU are located on a more local level. This is a distinctive feature compared to the medical devices sector in the United States or the pharmaceutical sector which are dominated by bigger companies. From a scientific perspective, the sector is expected to benefit from innovations based on the NBIC convergence or artificial intelligence in the upcoming years or decades.
As a highly sensitive field to technological change, regulatory requirements need to be periodically updated. In the EU, a new regulatory framework has been adopted in 2017, composed by Regulation 2017/745 on medical devices (MDR) and Regulation 2017/746 on in vitro diagnostic medical devices (IVDR). The two regulations are due to replace the framework developed in the 1990s consisting of three directives: Active Implantable Medical Device Directive (AIMDD 90/385/EE); Medical Device Directive (MDD 93/42/EEC); In Vitro Diagnostic Medical Device Directive (IVDMDD 98/79/EC). There are other legal instruments that complete, correct or help implement the regulatory regime. However, it should be stressed out that many aspects related to the implementation of these texts are still to be addressed and adopted. The building of a framework is an ongoing process.
The basic principle set out by the EU legislation is to ensure the smooth functioning of the internal market, taking as a base a high level of protection of health for patients and users. Medical devices go through a conformity assessment for their performance and security. Their evaluation is more or less stringent and depends on the risk they pose to human health. As other industrial products, medical devices bear the CE marking to indicate their conformity with one of the regulations so that they can move freely within the European Union and be put into service in accordance with their intended purpose. The focus on their impact on human health tend to outweigh their environmental impact. This could explain why environmental considerations have fallen outside the regulators’ purview when building a legal framework for medical devices.
However, concerns towards environmental sustainability are legitimate in this field. The healthcare sector is a source of greenhouse gas (GHG) emissions thus favoring air pollution and climate change. The sector is responsible for up to 5% of global carbon emissions. In the UK, the National Health Service (NHS) estimates that 30% of NHS emissions come from pharmaceuticals and medical devices. Besides GHG emissions, waste produced by the healthcare sector is another problem. It has been acknowledged that a large proportion of “clinical waste” is made up of single-use devices or packaging, often made of plastics. The personal protective equipment (PPE) littering during the Covid-19 crisis is a case in point. The waste is predominantly managed through incineration, which creates more emissions and air pollution, or sent to landfill. All these aspects deserve to be thoroughly researched and much is still to be learned about environmental impacts of specific medical devices, supplies and procedures.
As climate change and environmental issues have become a concern for many individuals and communities around the world, the need to ensure the protection of the environment is taking concrete steps. Launched at the end of 2019, the Green Deal is the European Union’s response to climate and environmental related challenges. The action plan is as much about protecting the environment as it is about building a sustainable future. Although the novelty of the document’s content may be disputed, as it seems to be more of an update of previous initiatives, the Green Deal is poised to be a game changer.
The European Green Deal invites stakeholders and scholars to read the legal framework applying to medical devices in a new light. It offers an opportunity to question existing legal tools in order to foster a climate friendly approach within the sector by encouraging sustainable manufacturing, use and disposal of medical devices. The scope of the article will be limited to the elements that are seemingly most relevant. Adventuring ourselves too much beyond the realms of the specific regime for medical devices requires a thorough research.
I. The State of Play in the Environmental Impact of Medical Devices
To assess the current state of play implies understanding sustainability in the context of medical devices and scrutinizing the existing potential of the two medical devices regulations in considering environmental impact.
A. The Green Deal in the Context of Medical Devices: the Need to Balance Different Interests
The starting point of any analysis of the theory and practice of sustainability with respect to medical devices is to understand the meaning of such a concept. The main definition was coined by the United Nations Brundtland Commission in 1987 and has since become a classic. Sustainability is defined in the following terms: “meeting the needs of the present without compromising the ability of future generations to meet their own needs”. From its outset, we are invited to reflect upon the balancing act between present and future, between progress (and innovation) on the one hand and sustainability on the other. At the time, the identified threats were the fast growing population and the limited carrying capacity of the available resources. After 35 years, while the feeling of emergency is more alive than ever, solutions are less provided by controlling population growth than by changing business models and habits.
The Green Deal confirms the necessity to transform our economy on the scale of the European single market, which goes beyond the European Union. It is set to accelerate the transition from a linear economy to a circular economy. Linear economies generally have the following pattern: extract resources, use them, then throw them away. They are build on a traditional “take, make, waste” model which still widely characterizes modern economies. A circular economy aims at being carbon neutral. It minimizes resource input, waste, emissions and energy losses. It can be achieved through long-lasting design, maintenance, repair, reuse and recycling. Circular economies posit transforming existing products in order to limit the use of new resources and reduce waste after a product is used. Another aim is to develop products with a sustainable life-cycle. Such a transformation requires time and innovation.
In the case of medical devices or other health products, the economic perspective and scientific innovation need to be complemented by another dimension, namely the protection of human health. The link between the protection of the environment and the protection of human health seems obvious. The United Nations Brundtland Commission had already asserted in its document that a broad-based health policy is essential for sustainable development. Public health is dependent on the state of the environment. Health and environment are not contradictory, they work hand in hand. This close relationship is best epitomized in the green oath of the Green Deal: “do no harm” which echoes the biomedical ethics principle “above all [or first] do no harm” (“primum non nocere”). This ad hoc principle of “environmental nonmaleficence” imposes an obligation not to inflict harm on our planet. It is worth noting that such a principle seems to be more acceptable and less demanding than “environmental beneficence” which would require strong positive actions to help our planet.
Beyond the holistic approach engaged by the Green Deal which entails that benefits in one field should not be weighed against environmental ones, practice demonstrates that a balance often needs to be stricken. Our approach towards development is clearly based on a benefit-risk determination. And at least from a perception standpoint the protection of health seems to prevail over the protection of the environment, albeit not contradictory. Building on their complementarity rather than differences should posit mitigating what may seem as a hierarchy.
The approach towards environmental sustainability in the sector of medical devices has been characterized by what we could identify as top focus areas. These areas were either specifically related to the characteristics of medical devices or related to general aspects surrounding industrial products or goods, a category to which medical devices belong. In this case, emphasis is placed on issues such as sustainable packaging, shipping or transportation and product end-of-life which is part of the waste management. These focus areas received much attention due to their potential business benefits. It is probable that the medical devices industry has not spearheaded the transition, but rather followed suit on other industries.
Focus on specific environmental risks raised by medical devices took longer to emerge. One can identify individual initiatives at a company level or, more interestingly, initiatives at an industry level that address environmental threats posed by medicinal products and the healthcare sector.Their aim is generally to raise awareness among the public and stakeholders. But they could also trigger behavior changes and if necessary substantial regulatory changes.
Two examples are worth mentioning. The first one is the Full Material Declaration (FMD) which is a tool promoted and supported through guidance by MedTech Europe, the European trade association representing the medical technology industries. The Full Material Declaration (FMD) consists in the disclosure of materials and substances contained in a product/medical device. The underlying goal is to “set the basis for future standardization in the field of material declaration”.
The second initiative is the “Safer Medical Devices Database” which is set out to be an online database intended to help staff responsible for procuring medical devices to carry out informed decisions and purchase medical devices that are free from DEHP, PVC free, and/or BPA. The tool is supported by the organization Health Care Without Harm which has also elaborated 15 recommendations to the European Union for sustainable healthcare. The database which is regularly updated is poised to be an assistance tool for regulatory bodies in dealing with the with the pre-market authorization process of medical devices, and for manufacturers and other interested parties to promote their products in the European market.
These similar examples of practices encouraging sustainability bring about a few comments. The environmental risk of medical devices has a human health safety component.
The shared goal of both tools is to enhance transparency of information in the supply chain and beyond for a broad range of actors: users, customers, manufacturers, suppliers, regulatory bodies… Access to loyal information is the sine qua non to a common and proper understanding of a situation and a key part to any decision-making process. Expected outcomes range from having more eco-conscious stakeholders willing to promote eco-friendly behavior, but also fostering regulatory change.
Within the emergency context of the Green Deal, this might denote a lack of ambition from the sector of medical devices. The aforementioned instruments are not binding and are limited in scope (limited number of devices and chemical substances and the identification of risky chemicals used in medical equipment does not always indicate sustainable alternatives).
B. Existing Provisions in EU Legislation: a Potential that Should not be Underestimated
The scrutiny of the main legal texts regulating medical devices shows us that these products are assessed for their safety and performance, not their environmental impact. It is mainly considerations on the protection of human health that have been deemed as falling strictly within the realms of regulating medical devices. This could also mean that the industry and its stakeholders have fallen short from seeing the benefits of having provisions on environmental sustainability in the legal framework of medical devices. The regulations do not include a definition on sustainable medical devices and the lexical field associated to environmental issues seems poor. The only explicit occurrence of the word “sustainable” appears when it comes to the idea of a “sustainable legal framework”.
However, both the MDR and the IVDR contain provisions which could be helpful in the context of the Green Deal. For the purpose of this paper, these provisions are divided into two main categories: definitions and tools.
The definitions we are interested in are the ones that allow considering medical devices with regard to their environmental impact. These definitions are quite diverse, but they tend to focus on specific features of a medical device such as its use, functioning or the nature of the its material constituents. They enable a better understanding of a medical device and they relate – albeit seemingly indirectly – to sustainability issues, such as reuse, recycle and reduce (the famous 3R rule).
For instance, the MDR defines a “single use medical device” as a device that is intended to be used on one individual during a single procedure. The process of “fully refurbishing” a device is described as “the complete rebuilding of a device already placed on the market or put into service, or the making of a new device from used devices, to bring it into conformity with this Regulation, combined with the assignment of a new lifetime to the refurbished device”. Within the context of the functioning of medical devices, definitions which could be of benefit include those of active devices, implantable medical devices. With respect to the material constituents and components of medical devices, we can find definitions on the following notions: derivative, nanomaterial, particle, agglomerate, aggregate.
The EU regulations also include tools and instruments that may contribute to improving the environmental impact of medical devices. These tools have primarily been set up to protect human health and the relationship between them and the environment does not seem obvious at first glance. However the path to foster sustainability in the medical devices sector can benefit from them.
One such instrument is the Unique Device Identification (UDI) system. The UDI consists in a series of numeric or alphanumeric characters that is created through internationally accepted device identification and coding standards and that allows unambiguous identification of specific devices on the market. It is an essential part of the traceability of medical devices. First introduced for the purpose of health protection, it may offer responses to purchase, waste disposal policies and stock-management of medical devices.
Tools enhancing transparency would enter the same category. The creation of a European database on medical devices (called Eudamed) aims at enhancing transparency through better access to information for the public and healthcare professionals. The public information would include data on the device, economic operators, conformity assessment. On the long term, information on the environmental impact could also be made available, although this does not seem currently planned.
These tools build on and encourage the sharing of information on medical devices. Contrary to the definitions seen above, they are not mere explanations of a feature of a medical device.
Beyond the specific legal framework of medical devices, other legal instruments tackle issues related to the environmental impact of medical devices. Are worth mentioning:
- REACH Regulation (EC) 1907/2006
- RoHS Directive 2011/65/EU
- WEEE Directive 2012/19/EU
- Biocidal Products Regulation (EU) 528/2012
- Circular Economy Package
The Restriction of Hazardous Substances Directive (RoHS Directive or RoHS 2) which is a directive banning hazardous substances in electronics has been covering electrical and electronic equipment, including certain medical devices and monitoring and control instruments since 2011. Together with the Waste Electrical and Electronic Equipment Directive (WEEE Directive which is a directive regulating electronic waste and recycling), it places the responsibility for product management throughout the life cycle of the product upon the manufacturers. Only medical devices belonging to the electronics industry, electrical and electronic equipment, such as active (implantable) devices are concerned. It is worth mentioning that electrical and electronic equipment used in the health care sector has generally received more attention.
II. Safe and Sustainable Medical Devices on the Horizon?
Having sustainable devices on the market is an enticing prospect which requires a good understanding of what “green” medical devices mean and of the possibilities to further regulate them.
A. Further Regulation of the Environmental Impact of Medical Devices
The most reasonable and lasting way to ensure sustainability for medical devices is to coin specific requirements in their legal framework. A general environmental policy could prove less successful in providing legal clarity. The implementation of the concept of Responsible Research Innovation (RRI) in the medical devices industry is a case in point. The RRI is a policy that aims at strengthening public trust and well-being by encouraging research and innovation with an added-value for society and the environment. Its absence from the regulatory framework could explain to some extent why it is widely ignored.
There are two main possibilities. Either we have specific provisions on the environmental impact of medical devices in the main legislation (i.e the MDR and the IVDR) or we include such provisions in the secondary legislation. For the European regime, the latter seems the option most at-hand at least on the short term. Generally EU regulations are expected to provide a comprehensive and functional framework for at least 20 to 30 years. Soft law instruments such as standards or guidelines offer the possibility to detail measures and adapt them to each particular context.
The legitimate question which arises is whether the legal basis of the regulations allows for the adoption of measures related to the environmental impact of medical devices. The answer might be found in article 168, paragraph 4, c) which provides that common safety concerns can be met through measures setting high standards of quality and safety for medicinal products and devices for medical use. With regard to the protection of the environment, the key term is “quality”. It is not defined in the text of the treaty or in the regulations, but it should be easy to reach an agreement on the fact that it is an overarching concept which goes beyond the protection of human health and could extend the ambit of the framework.
The presence of environmental sustainability in regulatory texts for medical devices is likely to become more common in the future. The United Kingdom may provide an interesting perspective into how a legislation on medical devices can make room for such. Since the MDR and the IVDR do not apply in British law, the United Kingdom needs to update its legal regime on medical devices which is inherited from the European Directives. To this end, early 2021, the UK has adopted the Medicines and Medical Devices Act. The purpose of the legislation is to confer power to amend or supplement the law relating to medical devices (or other health products), make provision about the enforcement of regulations, and the protection of health and safety, in relation to medical devices. Parliamentary debates on the Act are revelatory of interesting discussions, as British lawmakers considered amending the legislation to address the environmental issues raised by of medical devices. This would have have obliged the Secretary of State responsible for health care to « pay regard » to the environmental impact of medical devices. The main reason for considering this amendment is that many materials which are used to create these devices could be finite resources. Notwithstanding the withdrawal of the amendment for lack of implementation visibility, it denotes a concern to green the medical devices market.
In September 2021, a public consultation on the future regulation of medical devices in the UK was launched. The public consultation tackled product specific issues relating to medical devices and cross cutting themes. Chapter 13 titled “Environmental sustainability and public health impact” is supposed to seek input on environmentally sustainable practices in manufacturing usage and disposal of medical devices, environmental and public health impact assessments and electronic instructions for use (e-IFUs).
B. The Long Path from the Environmental Impact of Medical Devices to Sustainable Medical Devices
In order to foresee the content of future provisions that might foster sustainable medical devices we need to come back to one of the objectives of the Green Deal, namely the circular economy. One of the most comprehensive policy texts published to date by the European Commission concerns the field of chemistry. The Chemicals Strategy for Sustainability (CSS) is an ambitious political action plan for chemicals regulation in the EU released in October 2020. As chemistry plays a crucial part in the development of many of our products it offers an interesting overview of the European approach in dealing with sustainable materials. The strategy has been completed in April 2021 by a mapping study aiming at developing a Sustainable-by-Design criteria. The documents put the product at the center of the strategy for sustainability, by identifying three life stages of chemical products: the production stage, the use stage and the end-of-life stage.
Each one of these three stages could be put in the context of medical devices, although the specificities require deeper insight. For instance, the use stage of a medical device is often perceived as limited to its medical destination. But an increasing number of medical devices enable data collection on a large scale. The issues at stake are not only related to privacy for users and patients. Controlling the amounts and objectives of the amassed data while encouraging secure exchanges is part of a sustainable approach.
At least in theory, each of the three stages has far-reaching consequences and they need to be tackled as early as possible by developing and using criteria to assess their impact on the environment and public health. For medical devices, it is important accommodate safety and performance concerns with the potential for designing new products that are less harmful for the environment.
 See definition Regulation 2017/745, Article 2. For IVDs see definition.
 Examples of combination product include : pre-filled syringes and pens, reusable pen for insulin cartridges, drug-eluting stents, condoms with spermicide, etc.
 van Est, Rinie et al., From Bio to NBIC convergence – From Medical Practice to Daily Life. Report written for the Council of Europe, Committee on Bioethics, The Hague, Rathenau Instituut.
 Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (Text with EEA relevance), OJ L 117, 5.5.2017, p. 1–175, https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32017R0745.
 Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (Text with EEA relevance), OJ L 117, 5.5.2017, p. 176–332, https://eur-lex.europa.eu/eli/reg/2017/746/oj.
 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, OJ L 189, 20.7.1990, p. 17–36, https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=celex:31990L0385.
 Council Directive 93/42/EEC of 14 June 1993 concerning medical devices, OJ L 169, 12.7.1993, p. 1–43, https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex%3A31993L0042.
 Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices, OJ L 331, 7.12.1998, p. 1–37, https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=CELEX%3A31998L0079.
 See MDR, Recital (40) & IVDR, Recital (37).
 Sherman JD, MacNeill A, Thiel C. Reducing Pollution From the Health Care Industry. JAMA. 2019;322(11):1043–1044. doi:10.1001/jama.2019.10823: https://jamanetwork.com/journals/jama/article-abstract/2747470.
 Lenzen, M., Malik, A., Li, M., Fry, J., Weisz, H., Pichler, P., Chaves, L., Capon, A. and Pencheon, D., 2020. The environmental footprint of health care: a global assessment. The Lancet Planetary Health, 4(7), pp.e271-e279 :https://www.thelancet.com/journals/lanplh/article/PIIS2542-5196(20)30121-2/fulltext. Visit also : Peter-Paul Pichler et al 2019 Environ. Res. Lett. 14 064004 : https://iopscience.iop.org/article/10.1088/1748-9326/ab19e1/meta#erlab19e1s3.
 Delivering a ‘Net Zero’ National Health Service. NHS England. 2020.https://www.england.nhs.uk/greenernhs/wp-content/uploads/sites/51/2020/10/delivering-a-net-zero-national-health-service.pdf.
 HL (House of Lords – Grand Committee) Deb 26 October 2020. Arrangement of Business, Volume 807, Column 57GC, Available from : https://hansard.parliament.uk/lords/2020-10-26/debates/2dac49a1-bf9a-43f8-994b-a57e8c10c59a/GrandCommittee.
 Roberts, K.P., Phang, S.C., Williams, J.B. et al. Increased personal protective equipment litter as a result of COVID-19 measures. Nat Sustain 5, 272–279 (2022), https://doi.org/10.1038/s41893-021-00824-1 : https://www.nature.com/articles/s41893-021-00824-1.
 To read the Brundtland report : https://sustainabledevelopment.un.org/content/documents/5987our-common-future.pdf.
 European Parliament and Council Directive 94/62/EC of 20 December 1994 on packaging and packaging waste, OJ L 365, 31.12.1994, p. 10–23, https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex%3A31994L0062.
 COM(2019) 640 final, point 2.2.5.
 For more information on biomedical ethics, see Beauchamp Tom L. & Childress James F., Principles of Biomedical Ethics, Oxford University Press, Eighth Edition, October 2019.
 See MDR, Article 8 (2).
 See MDR, Article 2 (31).
 See MDR, Article 2 (4): depends on a source of energy other than that generated by the human body for that purpose, or by gravity.
 See MDR, Article 2,(5): medical devices which are put into the human body and at least in theory could be considered as more sensitive to the human body and environment.
 See MDR, Article 2 (15).
 See MDR, Recital (41).
 See MDR, Recital (44).
 ROHS2 Directive, Art 2, §4, h.
 Delre, A., La Placa, M.G., Alfieri, F., Faraca, G., Kowalska, M.A., Vidal Abarca Garrido, C. and Wolf, O., Assessment of the European Union Green Public Procurement criteria for four product groups, EUR 30943 EN, Publications Office of the European Union, Luxembourg, 2022, ISBN 978-92-76-46056-5, doi:10.2760/661750, JRC127215, https://publications.jrc.ec.europa.eu/repository/handle/JRC127215.
 Auer Alexander & Jarmai Katharina, Implementing Responsible Research and Innovation Practices in SMEs: Insights into Drivers and Barriers from the Austrian Medical Device Sector, Sustainability 2018, 10, 17; doi:10.3390/su1001001, https://mdpi-res.com/d_attachment/sustainability/sustainability-10-00017/article_deploy/sustainability-10-00017.pdf.
 i.e. Article 114 and article 168, §4, c) of the Treaty on the Functioning of the European Union.
 House of Commons, Public Bill Committee, Medicines and Medical Devices Bill (First sitting), 8 June 2020, column 15 Available from : https://hansard.parliament.uk/commons/2020-06-08/debates/778fd6ad-708c-4494-8ad6-0c5a90d28d41/MedicinesAndMedicalDevicesBill(FirstSitting).
 Guidance on the regulations for electronic instructions for use of medical devices was published 14 March 2013 : https://www.gov.uk/government/publications/electronic-instructions-for-use-of-medical-devices-guidance-on-regulations/guidance-on-the-regulations-for-electronic-instructions-for-use-of-medical-devices.
 COM(2020) 667 final: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=COM%3A2020%3A667%3AFIN