UK targets environmental impact of medical devices

The UK government has outlined plans to reduce the environmental impact and sustainability of medical devices in new regulations. These plans were revealed in the government response to the 2021 MHRA Consultation on the Future Regulation of Medical Devices. 

In the consultation, the MHRA put forward the following policy options:

1. Environmental impact assessment – Introducing a requirement in the Medical Devices Regulations for manufacturers to complete, as part of the conformity assessment of their medical device(s), an assessment of the device’s impact on both the environment and public health, a summary of which could be made publicly available to support informed choice. 
   
   
2. Waste management responsibilities – Introducing waste management responsibilities throughout the device supply chain, including reducing the environmental impact associated with a device (e.g. its manufacturer, use, packaging, disposal, recyclability etc), and using less hazardous materials to support disposability.
   
   
3. Reduction of substance and particle release – Introducing a requirement that devices must be designed and manufactured in a way that reduces, as far as possible, risks posed to public health by substances or particles that may be released from the device (e.g. wear debris, processing residues, degradation of products).
   
   
4. Electronic instructions for use – broadening the circumstances where electronic (not paper) labels and instructions for use can be used for medical devices, considering the need for patient safety and access. The Medical Devices Regulations currently already allow the flexibility of electronic instructions for use (e-IFUs), but only for specific devices and only in certain circumstances. 

There was strong support from respondents for additional requirements on the environmental impact of medical devices. Specifically, there was stronger support for the third (reduction of substance and particle release) and fourth (wider circumstances for e-IFUs) options. 

Therefore, the government intends to expand the circumstances in which e-IFUs can be deployed instead of printed, paper copies. This will allow e-IFUs for software and apps that are supplied directly to end users. Under the current Regulations, standalone software is provided the flexibility of e-IFUs, but only where the software is intended for exclusive use by professional users and use by other persons is not reasonably foreseeable. Other conditions also apply. Other than this expansion, the government does not intend to make any other changes. For example, there has not been any expansion of the specific devices covered:

a) active implantable medical devices and their accessories intended to be used exclusively for an indicated purpose and no other

b) implantable medical devices and their accessories intended to be used exclusively for that purpose and no other

c) fixed installed medical devices

d) medical devices and their accessories (whether general medical devices or active implantable medical devices) fitted with a built in system visually displaying the instructions for use

e) standalone software covered by the UK MDR 2002

However, the proposed amendment does ensure that the UK position on e-IFUs for standalone software mirrors the EU, set out in Regulation 2021/2226. 

In addition to widening the circumstances for e-IFUs, the government also intends to introduce the third policy option – reduction of substance and particle release. This will be done by amending the essential requirements in Part II of the UK MDR 2002, Annex I. The new essential requirements will specify that medical 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. The introduction of this requirement should not be particularly burdensome for those manufacturers who already have CE marking for the European market, as this is already included in the General Safety and Performance Requirements (10.4.1) of the EU MDR. 

Whilst the government does not intend to implement the other two proposals, it has not entirely ruled out introducing them in the future. There may need to be further consultation on these options given some of the views expressed, especially concerning potential duplication of requirements with regulations that apply across multiple sectors (e.g. REACH, CLP, RoHS). 

The government’s response to the consultation additionally proposes changes in other areas of medical device regulation, including changes to the classification system for IVDs, reliance on MSDAP certificates for devices that have received regulatory approval elsewhere, and a new premarket approval pathway for innovative MedTech products. The new regulations expected to be released in draft form before the end of 2022, and are scheduled to come into effect in July 2024.