Sustainability versus patient safety? Navigating the EU’s regulatory framework for medical devices

Posted: 27/11/2023

In recent years environmental, social and governance (ESG) issues have been increasingly prioritised by politicians, industries, and consumers alike, and the pharmaceutical industry is no different. As part of its Net Zero Strategy, the UK government earlier this year set significant carbon reduction targets for the NHS.

The ESG drivers for the UK’s supplier roadmap mirror green initiatives at the EU level, with the European Commission’s package of European Green Deal proposals intended to make sustainable products the norm in the EU. The EU's circular economy action plan proposes new rules to make almost all physical goods on the EU market more environmentally friendly, recyclable, and energy efficient throughout their whole lifecycle.

The healthcare sector is a major contributor to greenhouse gas emissions, amounting to an estimated 5% of the global total. In the UK, approximately 30% of NHS emissions are caused by medical equipment and pharmaceuticals. Also of environmental concern are the masses of clinical waste produced by single-use plastic medical devices – PPE, for instance.

There is a fundamental clash between the European Green Deal’s ‘circular’ models of sustainability, and the use of medical devices which are designed to be discarded after use for safety reasons. A difficult balancing act therefore emerges for pharmaceutical industry players when faced with regulatory obligations in both the health and safety and sustainability spheres.

Perhaps unsurprisingly, an analysis of the relevant European legislation reveals that, notwithstanding the recent package of green initiatives, the health and safety of patients is of greater importance to regulators than environmental sustainability.

Medical devices

Of specific interest to the pharmaceutical industry is the proposed extension of the existing ecodesign framework  which is expected to have an impact on medical device regulation.

The existing framework in the EU:

Health and safety
In the EU, the sale and distribution of medical devices is regulated under the EU’s Medical Devices Regulation, and the In Vitro Diagnostic Devices Regulation. These regulations impose compliance obligations throughout the lifetime of a medical device. Importantly, however, the regulations do not place limits on the permitted environmental impact of the device, instead focusing on patient health and safety.

The European Database on Medical Devices (EUDAMED), the IT system introduced to assist with the implementation of the regulations, is intended to be a central repository of information on the medical devices available on the EU market. The database is set to achieve full functionality in Q2 2024, although the information recorded will not include green credentials.

On a potentially positive note, the reprocessing of medical devices (whereby single use items can be sent to third party companies, to be cleaned, sterilised and returned for re-use) is permitted under the regulations. However, as European countries must opt-in to the regime to be able to participate, the impact may be limited.

It is important to note that the regulations do not apply in the UK as they came into force after the Brexit transition period.

Sustainability
The Ecodesign Directive 2009/125/EC sets the regulatory framework for energy-consuming products, and minimum mandatory requirements for the energy efficiency of certain products produced or sold in the EU. Although medical devices are not specifically included (nor excluded) from the scope of this legislation, it would be advisable for life sciences companies to ensure that their energy-consuming products meet the required standards.

As the Ecodesign Directive is not tailored specifically to medical devices, tensions emerge between the requirements of the legislation (as implemented nationally) and patient safety, in particular where medical devices require a constant electrical supply (such as, for example, CPAP machines, which are commonly used to treat obstructive sleep apnoea).

The labelling and advertising requirements for medical devices are also regulated at EU-level. Under the EU Energy Labelling Regulation 2017, products must be identified and labelled in accordance with a scale indicating different levels of efficiency. Again, using CPAP machines as an example, their primary objective (as a medical device) is to treat a condition, and that objective will prevail, even when a product is not necessarily the most energy efficient and must be labelled as such under this additional environmental obligation.

On 22 March 2023, the European Commission published the proposal for a directive on ‘common rules promoting the repair of goods’ (2023/0085 (COD)). Under the Sale of Goods Directive, the right for goods to be repaired currently exists only during the legal warranty period. The proposed rules seek to extend this right, in order to save costs for consumers through the initiation of a ‘circular’ economy, within which products must be repairable for a certain number of years.

The proposed regime would be complemented by the requirement for spare parts to be available for a period of time, as set out in the proposed Ecodesign for Sustainable Products Regulation. The ‘right to repair’ proposals would initially only apply to product categories listed under annex II, including washing machines and vacuum cleaners. However, the option exists for this list to be extended over time, so it is possible to imagine a scenario in the future where manufacturers of energy-using medical products, which may require shorter lives for health and safety reasons, could face challenges in respect of repair obligations.

A similar tension results from obligations under the Waste Framework Directive and its amending 2018 directive, as well as the Packaging and Packaging Waste Directive. The directives are vague as regards their application (or lack thereof) to medical devices. As medical devices may not be suitable for recycling, due to health and safety obligations, industry players find themselves within a grey area in respect of their responsibilities when disposing of medical products.

On the horizon: ecodesign for sustainable products

On 30 March 2023, the European Commission published a proposal for a Ecodesign for Sustainable Products Regulation, described as ‘the cornerstone of the Commission’s approach to more environmentally sustainable and circular products’. The regulation would address product design, which determines up to 80% of a product’s environmental impact.

The regulation would also extend the environmental obligations under the Ecodesign Directive to cover a wider range of products, which could include medical devices. It sets new requirements to make products more durable, reliable, reusable, upgradable, repairable, easier to maintain, refurbish and recycle, and energy and resource efficient. In addition, under the proposals manufacturers would be required to publish information about the product’s environmental impact. All regulated products will have digital product passports, making it easier to repair or recycle products, and facilitate tracking substances of concern along the supply chain. The proposal also contains measures to end the destruction of unsold consumer goods, as well as expand green public procurement and provide incentives for sustainable products.

Under paragraph 16 of the explanatory memorandum to the proposed regulation, the European Commission must, when establishing ecodesign requirements for medical devices, ‘take into account of the need to not negatively affect health and safety of patients and users’. Although this is a useful nod to the tensions between ESG and health and safety obligations, it remains to be seen whether the European Commission will introduce clear guidance for the life sciences industry.

It is clear that patient health and safety takes precedence over environmental sustainability in the EU from a regulatory perspective. We will need to see the inclusion of mandatory legislative provisions relating to green reporting, reprocessing, and research into sustainable alternatives before we can sustainably meet the needs of tomorrow, without sacrificing the health and safety needs of today.

Return to news headlines