Consultation outcome

Chapter 12 - Other Product Specific Changes

Updated 26 June 2022

The consultation considered whether a number of potential regulatory amendments could be made in relation to four distinct policy areas: the re-manufacturing of single use devices; systems, kits and procedure packs; parts and components; and custom-made devices.

The consultation invited views on the possibility of introducing additional legislative requirements for the re-manufacturing of single-use medical devices, which would bring this practice into the scope of the UK medical devices regulations rather than continue to rely on the guidance-based approach currently in place. This would provide additional clarity on the legal obligations that apply to re-manufacturers.

The consultation set out a number of additional requirements that could be put in place for assemblers of systems, kits and procedure packs. Our intention is that the UK medical devices regulations should include clearer requirements, particularly in relation to systems that include a combination of general medical devices, in vitro diagnostic medical devices (IVDs) and/or other products, with the aim of strengthening and clarifying the regulatory requirements to enhance patient safety.

The consultation invited views on introducing a number of regulatory requirements applicable to medical device parts and components, with the aim of ensuring that the safety of medical devices is not compromised in any way by the installation of replacement parts or components.

Custom-made devices are already covered by the UK medical devices regulations. The MHRA consulted on introducing additional safeguards for custom-made devices, including enhanced technical documentation requirements, obligations for manufacturers to have in place a Quality Management Systems (QMS) and more stringent post-market surveillance requirements

Section 67 - Re-manufacturing single-use devices

67.1 Proposals and feedback

The consultation invited views on whether the UK medical devices regulations should include specific requirements for re-manufacturers of single-use devices, including Quality Management System (QMS), post-market surveillance and labelling obligations, as outlined in the consultation. Out of 111 responses:

• 72% were in favour of introducing these requirements
• 10% were not in favour
• 17% did not know or had no opinion

Respondents were invited to outline any other requirements which they considered should be introduced for the re-manufacturing of single-use devices. A number of respondents reiterated their support or disagreement with the approach set out in the consultation. In addition, key themes can be summarised as follows:

• a re-manufactured device should be required to bear a label identifying it as re-manufactured
• need to consider implications (e.g., commercial sensitivity) associated with the re-manufacturer needing to have access to the original manufacturer’s technical files
• a need to consider whether patient consent is required for the use of re-manufactured single-use devices
• requirements should align with the EU MDR and the International Medical Device Regulators Forum (IMDRF)
• clear definitions are needed of the terms ‘re-manufacturing’ and ‘re-processing’

The consultation invited views on whether the UK medical devices regulations should introduce requirements for re-manufacturers of single-use devices on behalf of healthcare institutions. This included requiring that supply should be through a closed loop contract between the re-manufacturer and health institution and that the re-manufactured device should only be used on an individual patient during a single procedure - and be returned to the contracted re-manufacturer after that use, as set out in the consultation text. Of the 109 responses received:

• 62% were in favour of this approach
• 16% were not in favour of this approach
• 21% did not know or had no opinion

Consultees were asked to outline any other requirements which they considered should be introduced for the re-manufacturing of single-use devices within healthcare institutions. Key themes can be summarised as follows:

• the need to clearly define a ‘closed-loop contract’ and ‘healthcare institution’
• the need to clarify where the legal liability lies – e.g., in cases where an injury is caused by a re-manufactured single-use device (that is unrelated to it being re-manufactured)
• a rationale should be required for use of a re-manufactured rather than a newly manufactured single-use device, including an evaluation of safety and sustainability risks and benefits

The consultation invited views on whether the MHRA should allow the re-manufacturing of Class I single-use medical devices. Of the 106 responses received:

• 31% were in favour of the proposal
• 41% were not in favour of the proposal
• 27% did not know or had no opinion

There was a difference in the response here between individuals and organisations, with the majority of individuals being unsupportive of this proposal (61%), and organisations being evenly split, with 35% in support and 34% unsupportive of this proposal.

When asked to outline what requirements should be in place for the re-manufacturing of Class I single-use medical devices, respondents raised a number of themes, which can be summarised as follows:

• a need to consider the approach taken by other countries
• suggestion that there should be an abbreviated Approved Body process for re-manufactured Class I single-use devices
• suggestion that re-manufactured single-use devices should be subject to the same testing requirements as the original device

The consultation invited views on whether the MHRA should allow the re-processing of single-use devices. Of the107 responses:

• 38% supported this proposal
• 36% did not support this proposal
• 28% did not know or had no opinion

There was a difference in response between individuals (with 24% in favour, 55% not in favour and 21% being unsure or having no opinion) and organisations (with 31% in favour, 29% not in favour and 40% being unsure or having no opinion). Here, the majority of individual respondents were opposed to this change, with organisations being more evenly split.

The MHRA invited consultees to outline what requirements they considered should be in place for the re-processing of single-use devices. Respondents raised a number of points, including:

• an appropriate QMS should be required
• we should require evidence that the re-processed device has undergone assessment procedures that match or exceed those undergone by the original device
• a need to clearly define ‘re-processing’, ‘re-manufacturing’ and ‘single-use device’
• the device and packaging should clearly indicate that reprocessing has taken place

When asked to provide reasoning for the responses in Section 67, respondents raised a number of themes. These included:

• the need for careful regulation to maintain patient safety
• the need to ensure traceability of re-processed/re-manufactured medical devices
• approach would lead to more environmentally sustainable manufacture of medical devices
• identification of cost saving benefits to the original manufacturer and health institutions
• need to clearly define ‘re-manufacturing’ and ‘re-processing’
• devices that can be reused or re-processed should not be marketed as ‘single use’

67.2 The government response

After careful consideration of responses, it remains the government’s intention to proceed with proposals to regulate the re-manufacturing of single-use devices, as set out in the consultation. The majority of respondents were supportive of the consultation proposals, which would bring into scope of the UK medical devices regulations, factors that are currently set out in guidance. This will include requiring that the packaging and instructions for use clearly state that the single-use device is a re-manufactured version of the original and that the re-manufacturer can be clearly identified on the packaging and labelling.

We consider that a move from guidance-based best practice to regulatory requirements will provide clarity and increase patient safety, ensuring that appropriate enforcement can be taken against re-manufacturers who fail to abide by the regulatory requirements. In developing the regulations, we will give careful consideration to the important issues raised around patient consent and the commercial sensitivity issue raised around re-manufactures being able to access an original manufacturer’s technical file. We will supplement the regulatory changes with supportive guidance and ensure that any technical terms are clearly defined.

The majority of respondents were in favour of introducing requirements for persons who re-manufacture single-use devices on behalf of healthcare institutions. After careful consideration of feedback, it is the government’s intention to proceed with the approach outlined in the consultation. As such, we intend to require that the supply of re-manufactured single-use devices be through a closed loop contract between the re-manufacturer and the healthcare institution, and that a re-manufactured single-use device should only be used on an individual patient during a single procedure and, after that use, the single-use device should be returned to the contracted re-manufacturer.

The government has reflected upon feedback and intends to require that single-use devices that are re-manufactured on behalf of a healthcare institution be labelled as ‘re-manufactured’. We consider that this approach will provide clarity and transparency for clinicians deploying re-manufactured single-use devices.

In light of consultation feedback, the government intends to prohibit the re-manufacture of Class I single-use medical devices. We note that the largest proportion of respondents supported this approach and consider that the lack of Approved Body oversight for these devices would, at present, pose an unacceptable risk to patient safety. The government will, however, keep this issue under review with a view to considering it again in future, once the requirements relating to the re-manufacture of higher risk devices have bedded in.

Having taken account of consultation feedback, the government intends to introduce legislation that prohibits the re-processing of single-use medical devices, reflecting the policy approach set out in current MHRA guidance. Views on this matter were fairly evenly split among consultees, with a slight preference for allowing this practice. However, we consider that the potential benefits that this practice could yield would be outweighed by risks to patient safety, for example through misuse or cross-infection. It should be noted that the re-processing of multiple use devices will not be impacted by this decision.

Comprehensive guidance will accompany the new regulations in this area, to ensure that new regulatory requirements and relevant terminology are explained, including areas indicated by respondents, such as: definitions of ‘re-manufacture’, ‘re-processing’, ‘closed-loop contracts’, and ‘health institutions’.

Section 68 - Systems, kits and procedure packs

68.1 Proposals and feedback

The consultation invited views on whether the UK medical devices regulations should include the term ‘kit’ when referring to medical devices and products which are assembled together. Of the 141 responses received:

• 72% were in favour of including the term ‘kit’
• 12% were not in favour
• 16% did not know or had no opinion

The consultation sought feedback on whether the definitions of ‘systems’, ‘procedure packs’ and ‘kits’ should allow external software (for example, a specific app identified in the labelling) to be considered as a component of the system, procedure pack or kit. Out of 140 responses:

• 72% supported the proposal
• 6% did not support the proposal
• 21% did not know or had no opinion

Consultees were asked whether assemblers of systems, kits and procedure packs should be required to implement additional procedures relating to the selection and control of suppliers, risk management, handling of complaints and management of corrective and preventive actions with verification of their effectiveness. The consultation noted that the regulations could require that these procedures be outlined in the assembler statement / declaration. Of the 137 responses received:

• 70% were in favour of this proposal
• 13% were not in favour
• 21% did not know or had no opinion

When asked to outline any other requirements which should be introduced for system and procedure packs and the sterilisation of system and procedure packs, respondents raised the following themes:

• a need for clear guidance, e.g., covering requirements for labelling, packaging, cleaning and decontamination procedures and Declarations of Conformity
• suggestion that requirements should align with the EU MDR
• suggestion that an appropriate QMS should be required
• suggestion that full QMS should be required in accordance with ISO 13485
• suggestion that the assembler should be responsible for the handling and storage of each component and be able to sufficiently control that the storage and transit of the pack is compatible with each component

The MHRA next invited consultees to provide any reasoning for responses to section 68. Key points included:

• a need for traceability of the device and constituent parts
• suggestion that systems and procedure packs need to work safely for the intended purpose
• we should ensure a level of compliance that can be consistently implemented and assessed
• UK regulations should be aligned with other jurisdictions (such as the EU), and published IMDRF guidance to enable goods to move freely, reduce burden on manufacturers and facilitate a smooth implementation

68.2 The government response

After careful consideration of the feedback received, it is the government’s intention that the UK medical devices regulations will include the term ‘kit’. We also intend that the definitions of systems, procedure packs and kits will allow external software (for example, a specific app identified in the labelling) to be considered as a component of the system, procedure pack or kit We will also consider the need for further guidance on this topic.

In addition, the government intends to proceed with the introduction of additional requirements for assemblers of systems, kits and procedure packs, as outlined in the consultation text. We also intend to require that an appropriate QMS be put in place. We intend for the regulations to require that the required procedures be outlined in the assembler statement / declaration. We will reflect on the need for international alignment and consider the need for detailed guidance to accompany the regulatory changes.

Section 69 - Parts and components

69.1 Proposals and feedback

The consultation invited views on whether the UK medical devices regulations should require that any individual or company who supplies an item specifically intended to replace an identical or similar integral part or component of a medical device that is defective or worn should ensure that the item does not negatively affect the safety and performance of the medical device. Of the 133 responses received:

• 86% supported the proposal
• 5% did not support the proposal
• 9% did not know or had no opinion

Consultees were asked whether an item that is intended specifically to replace a part or component of a medical device and that significantly changes the performance or safety characteristics or the intended purpose of the medical device could be considered to be a medical device in its own right and therefore be required to meet the requirements of the UK medical devices regulations. Of the responses received:

• 79% were in favour of this approach
• 9% were not in favour
• 11% did not know or had no opinion

The MHRA invited consultees to set out any reasoning for responses to section 69. Key themes included:

• components should be regulated as medical devices in their own right
• service providers should be regulated as manufacturers
• components for a device that are not made by the original device manufacturer should continue to be available

69.2 The government response

After careful consideration of responses on replacing defective or worn parts, the government intends to proceed with the proposal to require any individual or company who supplies an item specifically intended to replace an identical or similar integral part or component of a medical device that is defective or worn to ensure that the item does not negatively affect the safety and performance of the medical device.

In addition, we intend to require that components which make a significant change to the safety and performance of a medical device are to be regulated as medical devices in their own right. We consider that, where a replacement part or component elicits a significant change to a device that affects its performance and safety, this invalidates the documentation associated with the device’s UKCA marking. Therefore, such parts and components should be regulated accordingly.

Section 70 – Custom-made devices

70.1 Proposals and feedback

The consultation invited views on whether the UK medical devices regulations should include more detailed requirements for the technical documentation that must be drawn up and kept by the manufacturer of a custom-made device, such as a clinical evaluation report, as set out in the consultation. Of the 108 responses received:

• 79% supported the proposal
• 9% did not support the proposal
• 11% did not know or had no opinion

The MHRA asked consultees whether the UK medical devices regulations should introduce more stringent requirements for the post-market surveillance of custom-made devices such as an obligation to produce periodic summary update reports or post-market surveillance reports.107 responses were received, of which:

• 51% were in favour of the proposal
• 28% were not in favour of the proposal
• 21% did not know or had no opinion

The consultation sought views on whether the UK medical devices regulations should require manufacturers of custom-made devices to implement a Quality Management System (QMS) which must be certified by an Approved Body. Of the 106 responses:

• 66% were in favour of this approach
• 14% were not in favour
• 20% did not know or had no opinion

The consultation asked respondents to outline the types/classes of custom-made devices should fall under the requirement to implement a QMS. The following suggestions were made:

• all device classes
• all device classes except Class I
• higher risk class medical devices (Class III and / or IIb)
• exclude custom-made dental crowns and bridges from the requirement

The consultation invited views on whether the UK medical devices regulations could be changed to clarify that the prescription written by a medical practitioner, who prescribes specific characteristics to the design of the custom-made medical device, can be an electronic prescription. Of the 103 responses received:

• 81% were in favour of this proposal
• 2% were not in favour
• 18% did not know or had no opinion

Consultees were invited to outline any further requirements which should be introduced for manufacturers of custom-made devices and to set out any reasoning for their responses to questions on custom-made devices. Key themes included:

• suggestion that the approach should align with IMDRF guidance
• a certified QMS should be required
• the term ‘medical practitioner’ needs to be defined
• having a clinical evaluation report is not practical for individual patients but there should be a ‘general’ one
• clear guidance is required

70.2 The government response

After careful consideration of responses and in light of the high level of support, it remains the government’s intention to proceed with the proposal to include in the UK medical devices regulation more detailed requirements for the technical documentation that must be drawn up and kept by the manufacturer of a custom-made device, as set out in the consultation.

We also intend to proceed with the introduction of more stringent requirements for the post-market surveillance of custom-made devices, as set out in the consultation. Although views on this proposal were relatively mixed, the highest portion of respondents were supportive. We consider that introducing these obligations will improve transparency and safety, allowing the MHRA and manufacturers of custom-made devices to identify issues and take action where necessary.

After careful consideration of responses regarding the requirement for manufacturers of certain custom-made devices to implement a Quality Management System which must be certified by an Approved Body, it is the government’s intention to proceed with this proposal for certain custom-made devices.

The government considers that Class III and IIb custom-made devices should require a certified QMS. A number of consultees were supportive of requiring a certified QMS for all custom-made medical devices. However, we consider that it would not be feasible to require a certified QMS for all custom-made medical devices as this would place a burden on Approved Bodies that is not commensurate to risk, particularly for custom-made dental crowns/bridges. It would be a requirement for class I and IIa custom-made devices to have an appropriate QMS in place - but the QMS will not require Approved Body certification.

We are grateful for the suggestions made by consultees regarding further requirements that could be introduced for manufacturers of custom-made devices. However, after careful consideration, we do not consider that additional requirements are needed beyond those outlined in the consultation. This matter will be kept under review.

It remains the government’s intention to proceed with the proposal to clarify in the UK medical devices regulations that the prescription written by a medical practitioner, who prescribes specific characteristics to the design of the custom-made medical device, can be an electronic prescription. The majority of consultation respondents supported this approach.