Out-Law News | 05 Jul 2022 | 8:00 pm |
New UK government plans to strengthen medical devices regulations to reduce their environmental impact and improve patient safety have been welcomed by one legal expert.
Helen Cline of Pinsent Masons said: “While medical devices are highly regulated to ensure safety and efficacy of the products and minimise the risk of harm to users and patients, the broader impacts of these devices on the environment and public health generally have not been an issue considered as part of the regulatory process. It is encouraging to see these issues being explored as part of this review of medtech regulation in the UK.”
In its response (155 pages / 1.25MB PDF) to a public consultation on a new UK medical technology (medtech) regulatory framework, the government said that respondents expressed a “high degree of interest” in environmental sustainability. However, some also raised important safety concerns, and noted that caution should be exercised when introducing new measures. Ministers said that they sought environmental outcomes that “compliment or enhance” patient safety, which they said remained their top priority.
Even before the Covid-19 outbreak, medical devices have had a significant environmental impact.
The government said there was strong support from respondents for its proposals to broaden the use of electronic instructions for medical products instead of printed copies. Ministers plan to extend this so that it applies to software and apps that are supplied directly to end users, as well as to health care professionals. It did not rule out extending the provision even further, and said it would keep the changes under review. It also said there was a “strong patient safety case” for the introduction of a requirement to ensure devices are designed and manufactured in a way that reduces 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 residue.
Ministers did, however, shelve a proposed requirement for manufacturers to complete an environmental and public health impact assessment as part of the conformity assessment process for a medical device. They will also not proceed with new waste management responsibilities in the medical device supply chain to reduce environmental impacts and increase the use of less hazardous materials that are easier to dispose of safely. The government said that it needed to consult further on both proposals to understand the “capacity and infrastructure concerns” that respondents raised.
Many respondents also noted that their products and practices are already subject to various environmental regulations and highlighted the need to avoid setting duplicative requirements. The government said it will consider publishing guidance on best practice covering this topic to support alignment with its net zero ambitions (368 pages / 36.2MB PDF) and NHS Net Zero Supplier Roadmap.
Cline said: “The environmental impact of medical equipment, particularly single-use devices and personal protective equipment, has been highlighted during the pandemic. However, even before the Covid-19 outbreak, medical devices have had a significant environmental impact. Inhalers, for example, contribute around 3% of total NHS greenhouse gas emissions. Many medtech companies have their own individual codes and sustainability strategies, but there is still a role for policy makers to adopt a framework to address the sustainability and environmental challenges in the healthcare sector more broadly.”
The government’s consultation response also confirmed that it would extend the scope of existing regulations to capture certain non-medical products with similar risk profiles, such as dermal fillers and coloured contact lenses. It will also strengthen the powers of the Medicines and Healthcare Products Regulatory Agency (MHRA) over the performance and safety of the highest-risk medical devices.
Ministers will also ensure that products which already have either the UKCA or CE conformity markings can remain on the market after the new regulations come into force, for a period of between three and five years depending on the device. The government will avoid duplication and minimise burdens on the industry by using Medical Device Single Audit Program (MDSAP) certificates to provide a tailored pathway to market approval for medical devices that have received regulatory approval from elsewhere.
Later this year, ministers will publish new regulations and guidance using powers in the 2021 Medicines and Medical Devices Act. The proposed changes are scheduled to come into effect in 2023 alongside a number of transition arrangements to ensure the industry has time to adapt.
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