Consultation outcome

Chapter 13 - Environmental Sustainability and Public Health Impacts

Updated 26 June 2022

As set out in the consultation, there are a number of ways in which the future regulatory regime for medical devices can improve and safeguard public health by driving more environmentally sustainable manufacture, use and disposal. Climate change is a health emergency, and the consultation included a number of possible options that could be taken forward to ensure that the new regulatory framework supports the government’s ‘Net Zero’ agenda where possible to do so, without infringing on other regulatory areas.

Section 71 - Environmental sustainability and public health impacts

71.1 Proposals and feedback

Respondents were asked to comment on the extent to which they or their organisation are already implementing, or planning, activities to reduce the impact of medical devices on the environment – and to outline key activities in this area.

Respondents identified a wide range of measures, indicating a considerable level of concrete action already underway, as well as interest in pursuing sustainability goals. The list below provides a snapshot of some of the activities referenced by respondents:

• measures to reduce carbon emissions at manufacturing sites and across the medical device supply chain, including in support of the delivery of NHS Net Zero targets, with support, guidance and training provided by Trade Associations
• waste management initiatives, including designing out waste – for example, through smaller products with fewer components, investment in recycling programmes, landfill diversion, move away from single use products, and recycling of plastic waste
• eco-design of products and packaging
• sustainable transport strategies, for example, through modal shift or ‘light-weighting’ of products and packaging
• reduction of hazardous materials in medical devices, including Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) and the Restriction of Hazardous Substances (RoHS) compliance
• reduction of packaging and increased use of recycled packaging
• sustainability and circularity strategies and targets, with buy-in from senior management
• use of procurement as a lever for sustainable practices

A small number of respondents, did not note any sustainability activities underway or planned, answering ‘none’, or ‘not applicable’. However, it is encouraging to see that a significant majority of respondents were actively engaged with sustainability initiatives, viewing this as a key priority.

The consultation invited views on whether there is a need for additional requirements to encourage economic operators to consider and/or mitigate the environmental impact of medical devices that they place on the UK market. Of the 202 responses received:

• 51% were in favour of this proposal
• 32% were not in favour of this proposal
• 17% did not know or had no opinion

Those who were in favour of additional requirements reasoned that there is a need to incentivise economic operators to act more sustainably, for example through encouraging the reduction of single-use products and plastics - or making certain components reusable, with patient-contacting components being single use. Respondents also highlighted that it would be beneficial to incentivise refurbishment and recycling of medical devices and avoidance of planned obsolescence. It was also noted that the information generated through environmental and public health impact assessments would increase transparency, thereby supporting sustainable decision making within health institutions. Some respondents noted a preference for incentives (such as tax relief) rather than legislative requirements and others caveated their support, stating that regulation in this area should not prevent the marketing of otherwise beneficial products that would address an unmet need. A number of respondents noted that activity in this area should be aligned with the NHS Net Zero ambition.

Those who were unsupportive of or unsure about this proposal noted that careful consideration must be given to any measures to promote sustainability, to ensure that patient safety is maintained and prioritised. For example, some respondents were concerned that measures to encourage reduced packaging could lead to devices enjoying less protection or a risk that sterility could be compromised. Some respondents were also concerned that additional measures could lead to increased bureaucracy and burden, particularly for small and medium sized enterprises (SMEs), which may in turn lead to delays in products reaching the UK market. Other consultees reasoned that action in this area is and will continue to be market driven, noting that manufacturers are already, for example, able to voluntarily adhere to relevant standards (International Organization for Standardization (ISO) standard 14001 was cited) and a preference for guidance rather than regulation. Reference was also made to cross-cutting regulations (such as the Plastic Packaging Tax Regulations) and levers (such as NHS procurement frameworks) that already address sustainability concerns - and a preference for horizontal rather than sector-specific regulation in order to avoid duplication. Finally, some respondents noted that environmental considerations are historically outside of the MHRA’s scope and expertise and felt that the Agency should maintain its focus on patient and public safety.

Respondents were asked for views on the options for change outlined in the consultation, which were:

a) introduce a requirement for manufacturers to complete an environmental and public health impact assessment as part of the conformity assessment process for a medical device, and to make publicly available a summary of this assessment

b) introduce waste management responsibilities into the medical device supply chain which could concern the reduction of the environmental impact associated with a device, and to consider using less hazardous materials that are easier to dispose of safely

c) introduce a requirement that devices must be designed and manufactured in a way that reduces, as far as possible, the risks posed to public health by substances or particles that may be released from the device including wear debris, degradation of products and processing residues

d) broaden the circumstances in which electronic (rather than paper) labels and instructions for use can be used for medical devices.

There was a considerable amount of support for the above proposals and acknowledgement that they would drive environmental sustainability within the medical devices sector. From the detailed comments, respondents were generally more supportive of options C (reduction of substance and particle release, including from wear debris) and option D (electronic instructions for use), than options A (environmental impact assessment) and B (waste management responsibilities). A significant portion of responses specifically called out support for wider use of electronic instructions for use and e-labelling and a small number suggested that we should require both paper and digital instructions for use for accessibility purposes and for consistency with obligations that apply to international markets.

Other comments and considerations that were highlighted included:

• Suggestion that there is a risk of duplicating other regulations and frameworks (for example, REACH, RoHS, CLP)^{[footnote 1]}
• Suggestion that the UK medical devices regulations are safety regulations, which should continue to be the priority, with respondents noting that careful consideration would need to be given to introducing sustainability requirements and that the UK medical devices regulations may not be the most appropriate vehicle for this
• Some respondents noted that environmental impact assessment requirements could be burdensome to SMEs and felt that they should not be linked to conformity assessment
• One respondent noted that Country of Origin information should be made available
• It was also suggested that local infrastructure and training are needed to support reuse, reprocessing, recycling and access to renewable materials

The MHRA invited views as to what other changes or key considerations are needed to ensure more environmentally sustainable medical devices. Several respondents emphasised the importance of the re-manufacturing and re-processing of single use devices and recycling of packaging. Others suggested that regulation should be agile and cost effective, and any new legislation should take into account the wider policy landscape to avoid setting duplicative requirements. Respondents also highlighted the importance of considering international regulations.

Some respondents felt that sustainability should be taken into account when designing medical devices so that it is considered at the earliest stages of manufacture and across the whole product lifecycle. It was also noted that financial support may be required to support businesses to adopt more sustainable practices and that a transitional period would be needed so that any new requirements could be phased in.

Respondents were next asked to set out the key implementation considerations for options A-D outlined above. Here, some respondents noted that clear regulation and guidance would be needed to ensure a shared understanding of the requirements - and that this should be linked to a clear overarching strategy. Again, reference was made to the need for a transitional period to allow for the phasing in of any new requirements.

Some respondents highlighted again, potential burdens or costs associated with the proposed requirements. Others felt that the focus should be on packaging recycling, waste management, e-labelling, electronic instructions for use, plastic reduction and reusability. There was also a suggestion that pharmacy take back schemes could be implemented.

Respondents were asked to identify which options they felt could be introduced quickly (within 1-2 years) and which could be introduced within a longer timeframe. Some respondents felt that a longer time period would be needed for all options. Others felt that only options A-C would require a longer time period, and that option D (electronic instructions for use) could be introduced more quickly. Respondents highlighted again that a transitional period would be required, should additional requirements be introduced.

71.2 The government response

Having considered the views of respondents, it is clear that there is a high degree of interest in the topic of environmental sustainability, with a wide range of views expressed. Many respondents noted that their products and practices are already subject to environmental regulation (for example, REACH, RoHS and carbon reporting were referenced) and there is a need to avoid setting duplicative requirements.

Respondents also raised important safety concerns, noting that caution should be exercised, and that careful consideration should be given to the introduction of sustainability measures, with the safety of medical devices being paramount. We would like to clarify that the intention of the proposals is to drive better environmental outcomes that compliment or enhance patient safety. It is recognised that climate change will have wide ranging detrimental impacts for public health and that medical device regulation has a role in supporting a move to Net Zero.

There was strong support for introducing option D and broadening the circumstances in which electronic instructions for use can be deployed instead of printed copies. On this basis, our intention is to extend this provision so that it applies to software and apps that are supplied directly to end users, as well as to health care professionals. In doing this, we will ensure that appropriate risk assessment and data protection requirements are put in place. We do not intend to extend this provision further at this point but will keep our position under review.

Based on consultation feedback, we also intend to introduce option C and will update the essential requirements to specify that devices must be designed and manufactured in a way that reduces, as far as possible, the risks posed to public health by substances or particles that may be released from the device including wear debris, degradation of products and processing residues. We consider that there is a strong patient safety case for taking this approach.

In light of the consultation feedback, we think there is a need to give further consideration to options A and B, possibly including further consultation, to gather further evidence that would provide a better understanding of the capacity and infrastructure concerns that were raised. This approach would also allow us to give more detailed consideration to consultation feedback regarding the need for horizontal, rather than product-specific regulation (thus avoiding duplication with cross-cutting requirements) and to identify any gaps in the policy and regulatory landscape and areas for which the MHRA can feasibly and appropriately provide support.

While we do not intend to introduce new regulatory requirements on these issues at this point, we will keep this under review, with a view to gathering additional evidence and consulting further (as noted above). Given that respondents outlined a range of existing sustainability frameworks and initiatives, we will consider publishing guidance on best practice covering this topic to support alignment with government Net Zero Ambitions and NHS Net Zero Supplier Roadmap: Greener NHS » Suppliers (england.nhs.uk).

1. CLP: Regulation (EC) No 1272/2008 on the classification, labelling and packaging of substances and mixtures (retained EU law), REACH: Regulation (EC) No 1907/2006 on the Registration, Evaluation, Authorisation and Restriction of Chemicals (retained EU law), RoHS: Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment Regulations 2012/3032 ↩