Consultation outcome

Chapter 3 - Economic Operators

Updated 26 June 2022

There are a number of areas relating to economic operators for which the UK medical devices regulations are out of step with international best practice. This chapter of the consultation sought to address these areas, covering:

• essential requirements that could be amended to enhance and safeguard public and patient safety
• manufacturer requirements relating to recompense to cover any legal liability arising from adverse incidents
• ‘in-house’ manufacture of medical devices by health institutions - to more comprehensively regulate such devices to safeguard the health and safety of UK patients
• distance sales - to more closely regulate the sale of devices or services via electronic means and provide greater protection for UK consumers
• claims made about devices - to prevent misleading or unsubstantiated claims being made and safeguard the safety of patients and the public
• more detailed requirements about the Quality Management Systems manufacturers must have in place, improving consistency in this area
• clarification of UK Responsible Person requirements to ensure they can fulfil their obligations more effectively, to enhance patient and public safety
• importer and distributor obligations, to improve device traceability and ensure the safe supply of devices to the UK market
• a requirement for manufacturers and UK Responsible Persons to have access to a Qualified Person, to support manufacturers’ regulatory compliance
• the circumstances in which economic operators other than the manufacturer, such as importers, are required to take on the obligations of a manufacturer, and to specify which requirements they should follow

Section 6 - Essential requirements for medical devices

6.1 Proposals

The MHRA consulted on amending the UK medical devices regulations to add further detail to the existing essential requirements that apply to medical devices, and to add further essential requirements in line with technological progress and international best practice to deliver public and patient safety benefits. The consultation provided examples of how the essential requirements could be amended.

6.2 Feedback

Out of 260 responses:

• 78% were in favour of amending the essential requirements of the UK medical devices regulations in line with the approach outlined in the consultation
• 15% did not support this approach
• 7% did not know or had no opinion

In response to the follow-up question inviting views on other amendments that should be made to the essential requirements, 157 respondents provided comments and raised the following common themes:

• post-market clinical studies should be required for high-risk devices
• a desire to align with international frameworks, including the EU Medical Devices Regulation (2017/745) (EU MDR), the EU in vitro Diagnostic Medical Devices Regulation (2017/746) (EU IVDR), International Organization for Standardization (ISO) standards ISO 14971 and ISO 14155, and the International Medical Device Regulators Forum’s (IMDRF’s) Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices
• explicit requirements for human factors, usability testing, electronic programmable devices and cyber security
• information on labelling around the disposal or recycling of medical devices
• disclosure or transparency of risks and benefits of the device and its materials so patients can make informed decisions, with regard to allergens, human tissue, animal tissue and wear debris
• ability to track the device using a Unique Device Identification (UDI)

Respondents were also asked to provide reasoning (including any available relevant evidence) to support their answers to the questions on essential requirements, with the key themes from 185 responses summarised as follows:

• significant support for aligning with EU MDR/IVDR, with some referencing a desire to align with the General Safety and Performance Requirements (GSPRs) in particular
• requirements need to keep pace with rapid technological change
• be mindful that there is limited space on a label to include additional information
• the approach should align with medicinal products in terms of having allergen and sensitiser lists.

6.3 The government response

After carefully reviewing the feedback received, it is the government’s intention to amend the essential requirements for medical devices, accommodating technological progress and, where in the interests of the UK, aligning with other regulators in delivering international best practice.

As noted above, a significant number of responses requested close alignment with the GSPRs set out in the EU MDR and IVDR, to avoid confusion and potentially duplicative or divergent requirements and to facilitate the ongoing supply of devices to the UK market. In light of this, our intention is to broadly reflect the GSPRs in the UK regulations, tailored to the domestic context.

As set out in the consultation, the intention is to include a requirement to list ingredients or component parts which are known allergen or sensitisers (for example, natural rubber latex and chlorhexidine).

This approach is aimed at delivering public and patient safety benefits, as set out in the consultation and summarised above. The MHRA will take consultation feedback into consideration in the delivery of this work.

Section 7 - Manufacturer obligations – measures for recompense

7.1 Proposals

The MHRA consulted on potentially introducing a requirement for manufacturers to have measures in place (for example, sufficient financial coverage), proportionate to the risk class, type of device and the size of the company, to cover any legal liability arising from adverse incidents with medical devices that they place on or supply to the UK market. This, for example, could include a requirement for manufacturers to hold appropriate liability insurance.

7.2 Feedback

Of the 219 responses for this section:

• 65% supported this approach
• 16% were unsupportive
• 18% did not know or had no opinion

Respondents were asked to set out their reasoning for their response to the above question. Common themes from the 161 responses included:

• concern that the costs of obtaining liability insurance may be prohibitive, particularly for small and medium-sized enterprises (SMEs), and that setting overly prescriptive requirements could impact on the attractiveness of the UK market, which could in turn stifle innovation and cause supply issues
• concern about possible impacts on health institutions
• that the MHRA should take a risk-based approach
• that most reputable businesses already have adequate insurance in place to provide recompense
• that the government should establish and require manufactures to contribute to a compensation fund that could be used to compensate medical device users in the event of adverse incidents
• that recompense measures should be linked to defective devices, and not to clinical or user error
• a desire to align requirements with the EU MDR and IVDR

7.3 The government response

Having considered the wide range of views expressed by respondents, it is noted that the majority were in support of the approach outlined in the consultation. The government therefore intends to introduce a requirement for manufacturers to have measures in place (for example, sufficient financial coverage) for providing recompense to those impacted by adverse incidents with medical devices on the UK market.

The government considers this approach to be necessary as it will help ensure that those negatively impacted by an experience with a medical device are adequately and appropriately compensated. It is not intended to establish a centralised compensation fund at this time, as requested by some consultation respondents, as it is considered that introducing provisions to ensure manufacturers have sufficient financial coverage in place to respond in the event of an adverse incident would provide for patient recompense via alternative means.

The government has also noted the important points raised in the consultation feedback regarding the need for flexibility in terms of how this requirement is met and will provide guidance on this matter to accompany the regulatory changes. The MHRA will consider potential impacts on SMEs as the regulations and guidance are developed. However, as set out in the consultation, the intention here is that requirements will be commensurate with the type of device, risk class and size of company.

Section 8 - Health Institutions

8.1 Proposals and feedback

The MHRA consulted on introducing a range of measures that would apply to medical devices that are manufactured or modified within a health institution (for example, an NHS hospital) for use within that health institution.

The consultation asked whether the regulations should include a definition of the term ‘health institution’. Out of 182 respondents:

• 89% were in favour of including a definition
• 7% were not in favour
• 5% did not know or had no opinion

The consultation next invited views as to how health institutions should be defined. Feedback from the 148 respondents can be summarised as follows:

• a desire to align with definitions used in the EU MDR/IVDR
• calls from different respondents for the definition to either include or exclude private institutions
• a request for clarification or guidance on the definition of a health institution, and whether it includes entities such as dentists, research institutes, universities, and pharmacies
• a request that, in defining health institutions, we consider situations in which there is collaboration between health trusts

The MHRA consulted on amending the UK medical devices regulations to clarify that medical devices manufactured and modified ‘in house’ must meet the relevant essential requirements. There were 183 responses, of which:

• 84% supported this approach
• 5% did not support this approach
• 11% did not know or had no opinion

Response rates to the corresponding question in the abridged consultation (Chapter 17) were in alignment:

• 85% of respondents supported this approach
• 5% did not support of this approach
• 9% did not know or had no opinion

Those in support of introducing these requirements (in response to Chapter 17) were asked to select which of the requirements from the list below they considered should be met by health institutions. The percentage rates of the 51 respondents that selected each option are as follows:

• meet the relevant essential requirements of the UK medical devices regulations (80%)
• draw up a publicly available declaration that devices meet the essential requirements of the UK medical devices regulations (61%)
• apply a suitable organisational infrastructure (a Quality Management System) (76%)
• justify why the target patient group’s needs cannot be met with an equivalent device available on the market (65%)
• keep technical information available for the MHRA, review clinical use of the devices and take necessary corrective actions, for example, stop further use of the device in patients where there is an issue (75%)
• report certain types of incidents relating to ‘in house devices’ to the MHRA (84%)
• register devices produced or modified ‘in house’ with the MHRA (67%)
• other (please specify) (0%)
• don’t know/no opinion (6%)

The consultation invited Chapter 17 respondents to comment on the rules that should apply to devices that are manufactured and used ‘in house’. Feedback can be summarised as follows:

• patient safety is paramount
• devices manufactured and used within health institutions should be compliant with the regulations
• there is a risk that having an exemption could create regulatory loopholes
• respondents noted concern that over-regulation of such devices could cause supply issues and stifle innovation

In addition, the consultation asked (in Chapter 3) whether ‘in house’ manufactured devices should be exempt from UK Conformity Assessed (UKCA) marking requirements. There were 182 responses, of which:

• 49% considered that there should be an exemption
• 34% did not support an exemption
• 17% did not know or had no opinion

There was a difference in responses by demographic group, with 47 responses from individuals (36% supported an exemption and 51% did not support and exemption and 133 responses from organisations (53% supported an exemption and 29% did not). This indicates a greater level of support from organisations than from individuals for the UKCA marking exemption, though the disparity in the overall volumes of responses from these two groups should be noted.

The MHRA consulted on introducing provisions that would mean health institutions would need to meet certain requirements for ‘in house’ manufacturing, including obligations as outlined in the consultation text. Of the 184 responses to this proposal:

• 76% were in support
• 8% were not in support
• 12% did not know or had no opinion

Respondents were asked to outline any other requirements that should be introduced for health institutions carrying out ‘in house’ manufacturing or modification of medical devices. The consultation received feedback from 123 respondents, including:

• health institutions should be required to have a certified Quality Management System (QMS), with consideration for a simplified requirement
• the exemption should apply to software, artificial intelligence and machine learning
• there should be document retention requirements
• we should include requirements for clinical evaluation
• we should include Qualified Person requirements
• health institutions should be subject to audits, with both internal and MHRA-led audits suggested

The MHRA consulted on amending the UK medical devices regulations to require health institutions to register medical devices manufactured or modified ‘in house’ with the MHRA. Of 183 responses:

• 73% supported this approach
• 14% did not support this approach
• 14% did not know or had no opinion

We also consulted on requiring health institutions to register with the MHRA, clinical investigations and performance studies involving medical devices manufactured or modified ‘in house’. Of the 181 responses:

• 77% supported this approach
• 9% were not in support
• 14% did not know or had no opinion

In addition, the consultation sought views on whether the MHRA should be able to request that the relevant health institution provides further information about the devices it has manufactured or modified ‘in house’, including details about the manufacturing processes. The consultation also asked whether the regulations should require the MHRA to restrict the use of such devices that have been manufactured or modified ‘in house’ and to inspect the activities of relevant health institutions. There were 179 responses to the question on these proposals, of which:

• 83% supported this approach
• 6% did not support it
• 12% did not know or had no opinion

The consultation asked whether the regulations should clarify that the health institution exemption shall not apply to medical devices manufactured on an ‘industrial scale’ and that such medical devices must meet all the relevant provisions of the UK medical devices regulations. There were 181 responses, of which:

• 76% supported this approach
• 10% were unsupportive
• 14% did not know or had no opinion

Respondents were asked to outline their reasoning to support their answers to the preceding questions on health institutions. The following points were raised:

• there is a need to define what is meant by ‘industrial scale’
• there should not be a health institution exemption
• the requirements align with the EU MDR/IVDR
• there should be a requirement for the health institution to inform the original equipment manufacturer (OEM) of any modifications made to the OEM’s devices
• when modifying commercially available devices, health institutions should be required to assume manufacturer responsibilities

The consultation invited views on whether the regulations should provide that the health institution exemption applies to a health institution which provides routine or a specialist diagnostic service to other health institutions (for example, the Supra-Regional Assay Service). There were 175 responses, of which:

• 38% were in favour of this approach
• 29% were unsupportive
• 33% did not know or had no opinion

The consultation asked consultees to outline any circumstances in which the exemption should not apply (for example, if the services are provided for commercial or profitable purposes, or to private patients or providers outside its intrinsic health function) and to provide reasoning for their responses. Responses to this question indicated broad agreement that the exemption should not apply in cases where services are provided for commercial or profitable purposes.

8.2 The government response

The government intends to include a definition of the term ‘health institution’ in the UK medical devices regulations. A wide range of views were put forward and, overall, respondents broadly welcomed the intention to provide clarity here. Our intention is to include a definition of ‘health institution’ within the regulations and to provide further detail in supplementary guidance, taking account of points raised in the consultation. In light of the consultation feedback, we intend to take as a starting point, the definitions set out in the EU MDR and IVDR, which define a health institution as an organisation, the primary purpose of which is the care or treatment of patients or the promotion of public health.

A common theme raised in response to the free text questions in this section was that there should not be any exemption for health institutions. The intention is that health institutions will be required to meet many of regulatory requirements that apply to commercial manufacturers – and the changes that are intended to be introduced will, in certain circumstances, place more extensive requirements and greater scrutiny upon health institutions than are currently in place. The key differences will be an exemption for health institutions from UKCA marking requirements, an exemption from the requirement for Approved Bodies to be involved in the conformity assessment process and an exemption from the requirement to have a certified QMS, though a QMS will still be required. It is considered that there is a strong case for taking this approach so that health institutions can continue to serve patients with rare conditions, whose needs may not otherwise be met by an equivalent device available on the market from a commercial medical device manufacturer.

The government intends to require that ‘in house’ manufactured or modified devices meet the relevant essential requirements of the UK medical devices regulations. This will ensure that devices manufactured in these circumstances will be fit for purpose and as safe for use as any commercially produced device. Noting the comments about potentially creating supply issues and stifling innovation, the government does not accept that this is suitable rationale for allowing such devices to be manufactured and used on patients without meeting the same essential requirements a similar commercially produced device would be required to adhere to.

The largest portion of respondents were in favour of exempting ‘in house’ manufactured medical devices from full UKCA marking requirements. It is intended to introduce this provision as the devices in question will be put directly into service and will not be placed on the market. An exemption from UKCA marking requirements would be intended to reduce the burden on health institutions, which in turn would encourage and enable them to produce their own innovative devices for patients. As outlined above, it is considered that this will deliver clear benefits to patients, particularly those with rare conditions whose clinical needs may not otherwise be met by commercial medical device manufacturers.

The government intends to require health institutions to meet the requirements that were set out in the consultation. This will include QMS requirements, technical document retention requirements and provisions on adverse incident reporting. It is considered that this approach will increase transparency and accountability and will deliver patient safety benefits.

Given the positive consultation response on this topic, the government intends to introduce a requirement for health institutions to register medical devices that have been manufactured or modified ‘in house’. The MHRA will provide further guidance on these requirements to accompany the regulatory changes.

Having considered the views of respondents, it is noted that the majority of respondents supported the proposal to require health institutions to register clinical investigations and performance studies with the MHRA. The government intends to proceed with this proposal as outlined in the public consultation.

The government notes that the majority of respondents supported the proposal to amend the UK medical devices regulations to enable the MHRA to request that the relevant health institution provides further information about the devices it has manufactured or modified ‘in house’, including details about the manufacturing processes. It is the government’s intention to introduce this provision.

The majority of respondents were supportive of devices manufactured or modified ‘in house’. Under the existing legal framework, the MHRA will continue to be able to inspect the activities of relevant health institutions for compliance with the Medical Devices Regulations 2002 and take enforcement action to restrict the availability of devices. We consider that this allows the MHRA to take a pragmatic and flexible approach as part of its market surveillance and compliance activities.

The majority of respondents supported the exclusion from the health institution exemption of medical devices manufactured on an ‘industrial scale’. We therefore intend to introduce this provision. A number of respondents sought clarity on the definition of ‘industrial scale’. The MHRA will give this matter further consideration and will consider the need for supplementary guidance.

The consultation asked whether the ‘in-house exemption’ should apply to health institutions which provide routine or specialist diagnostic services to other health institutions. It should be noted that, to qualify for the exemption, the device will need to meet a patient group’s specific need that cannot be met (or cannot be met at the appropriate level of performance) by an alternative device on the market. While the largest portion of responses expressed support for this proposal, there were similar levels of opposition to it. The intention is to proceed with this approach - our proposed regulatory changes will provide clearer expectations and allow greater oversight of such service provision, including on when the exemption will not apply. We have also taken account of the efficiency benefits that this approach is likely to provide to the NHS. In line with consultation feedback, our intention is that the exemption will not apply in cases where services are provided for commercial or profitable purposes.

Section 9 - Distance sales

9.1 Proposals and feedback

The MHRA consulted on amending the UK medical devices regulations to clarify that a medical device, or any diagnostic or therapeutic service involving a medical device (whether in return for payment or free of charge), must comply with the regulations if it is sold or provided at a distance through electronic means. It was noted that this would be the responsibility of the person selling or offering the medical device or diagnostic or therapeutic service and that, where the person supplying the device or service is an economic operator (for example, a manufacturer or importer), they would also need to follow the relevant obligations under the UK medical devices regulations. There were 188 responses, of which:

• 88% were supportive of this proposal
• 6% were not supportive
• 6% did not know or had no opinion

The consultation invited views on proposals that, upon request from the MHRA, any individual, company or organisation offering a medical device by means of distance sales could be required to provide a copy of the Declaration of Conformity of the medical device concerned. There were 187 responses, of which:

• 88% supported this approach
• 5% were not supportive
• 6% did not know or had no opinion

The consultation invited comments on any other requirements that consultees considered should be introduced for medical devices that are subject to distance sales and asked that they provide any rationale for their views. Key themes raised in the free text responses can be summarised as follows:

• relevant websites and instructions for use should state that UKCA marking requirements have been met
• importer contact details should be provided for vigilance purposes
• rules on distance sales should only apply to products destined for UK consumers

9.2 The government response

Having considered the views of respondents the government is minded to explore in more detail the scope to proceed with the above proposals and will have further cross-government discussions to ensure that our approach aligns, where appropriate, with similar measures in place for other products placed on the UK market.

Section 10 - Claims

10.1 Proposals and feedback

The MHRA consulted on proposals to amend the UK medical devices regulations to prohibit, insofar as they are not adequately prohibited in other legislation, the use of text, names, trademarks, disclaimers, pictures, images, videos and figurative or other signs that may mislead the user or the patient with regard to its intended purpose and the safety and performance of the medical device.

The MHRA also noted that the regulations could be amended to provide that a person who makes a misleading claim on the device labelling, instructions for use, packaging or sales material / advertising (including online) is responsible for this. Out of 203 responses:

• 91% of respondents were in favour of these proposals
• 5% were not supportive
• 4% did not know or had no opinion

The consultation invited consultees to set out their reasoning to support their response. Key points can be summarised as follows:

• strong support that claims relating to a medical device should be accurate
• many called for alignment with EU regulations and other jurisdictions
• further comments called for legal liability and the term ‘misleading’ to be clarified fully in guidance

10.2 The government response

Having considered the views of respondents, it is noted that there is significant support for introducing requirements for claims made about medical devices to ensure that any such claims accurately reflect the safety, performance and intended purpose of the medical device. In light of this, the government intends to proceed with the proposals as outlined in the consultation text.

As outlined in the consultation and recognised by respondents, a key feature of this proposal is that it is intended to enhance patient safety and provide greater transparency for users of medical devices. The intention is to provide in the legislation, examples of instances where a claim would be misleading, and to supplement the regulatory changes with guidance, which will provide further detail as to what constitutes a ‘misleading’ claim, as requested by respondents.

Section 11 - Quality Management Systems

11.1 Proposals and feedback

The MHRA consulted on proposals to amend the UK medical devices regulations to clarify that all manufacturers should have a Quality Management System (QMS) in place, which addresses the requirements outlined in the consultation text, at a minimum. Out of 259 responses:

• 80% thought that the detailed requirements for QMS should be introduced as outlined in the consultation
• 9% were unsupportive of the proposals
• 2% did not know or had no opinion
• 9% selected ‘other’

Respondents that selected the ‘other’ option provided further comments in relation to the proposed detailed requirements for QMS. These included a call to adopt International Organization for Standardization (ISO) standard 13485, suggestion that we should align with QMS requirements used within the EU or other international jurisdictions and a need to minimise burdens on SME innovators.

Respondents were asked to outline any other requirements which should be included in a manufacturer’s QMS. Of the 139 responses received, some took the opportunity to reiterate general support for international alignment, particularly with EU MDR/IVDR requirements, to highlight a preference for following ISO 13485 and to request that QMS requirements should be proportionate to the risk class of a medical device.

The consultation asked consultees for views on whether all manufacturers, including Class I and general IVD manufacturers, should be required to apply an appropriate QMS. There were 259 responses, of which:

• 90% supported this proposal
• 5% were not supportive
• 5% did not know or had no opinion

Respondents were then asked to provide their reasoning (including any available evidence) to support their answers to the questions on QMS. Several themes were raised in the 200 free text responses, and key themes can be summarised below:

• respondents noted a preference to align the QMS requirements as closely as possible to ISO 13485 as most manufacturers and jurisdictions use this standard
• recognition that QMS supports good practice around risk management, which is crucial for the safety of medical devices and which should be proportionate to the risk of the device
• external audit is also beneficial to ensure processes are followed
• regulatory guidance is needed to clarify what is meant by an ‘appropriate’ QMS

11.2 The government response

After careful consideration of responses, it remains our intention to proceed with the proposal to introduce the detailed requirements for QMS that address the aspects outlined in the consultation. In addition, the government recognises that there is a desire to have QMS requirements that are proportionate to the risk class of the medical device.

The government intends to require all medical device manufacturers, including manufacturers of Class I devices, custom-made devices and general in vitro diagnostic medical devices (IVDs) to apply an appropriate QMS. This requirement will also apply to health institutions. A significant proportion of respondents supported the approach set out in the consultation and we consider that consistency and clarity in this area will deliver patient safety benefits. The MHRA will provide further guidance on QMS requirements

Section 12 - UK Responsible Persons

12.1 Proposals and feedback

The consultation included several questions on requirements that should apply to UK Responsible Persons (UKRPs). Within this section, the consultation sought views on whether the regulations should include an explicit requirement for UKRPs to be physically located in the UK. Out of 241 responses:

• 71% supported this proposal
• 19% were not supportive
• 10% did not know or had no opinion

The consultation asked whether the UKRP should be legally liable for defective medical devices on the same basis as the manufacturer. There were 239 responses, of which:

• 46% supported this approach
• 40% were not supportive
• 13% did not know or had no opinion

The MHRA consulted on setting more detailed requirements regarding the written evidence that a UKRP must provide the MHRA to verify that they have the manufacturer’s authority to place a medical device on the market. Here, the MHRA proposed that the written evidence could be in the form of a legal contract. There were 236 responses, of which:

• 82% were in favour of introducing this proposal
• 9% were not in favour
• 9% did not know or had no opinion

The consultation invited views on whether the UK medical devices regulations should include a requirement for manufacturers to draw up a changeover agreement when changing their UKRP. This would be an agreement between the manufacturer, the incoming UKRP and the outgoing UKRP. There were 237 responses of which:

• 78% were in favour of the proposal
• 9% were not in favour
• 13% did not know or had no opinion

The MHRA consulted on amending the technical document retention timescales that apply to UKRPs and set out a range of possible options, as outlined below. There were 213 responses regarding UKRP document retention requirements for implantable devices, which can be summarised as follows:

• 11-15 years after the last product has been manufactured (28%)
• 16-20 years after the last product has been manufactured (8%)
• for the expected lifetime of the device, after the last product has been manufactured (42%)
• other (please specify) (23%) - suggestions included:
  • 5 years after placing on market
  • retain forever
  • this should not be a requirement for UKRPs
  • expected lifetime of device with additional number of years as a buffer
  • lifetime of patients
  • there should be a central repository for these documents

Regarding the specified period for the retention of technical documentation relating to non-implantable devices, 224 respondents answered as follows:

• 1-5 years after the last product has been manufactured (13%)
• 10 years after the last product has been manufactured (24%)
• 11-15 years after the last product has been manufactured (9%)
• for the expected lifetime of the device, after the last product has been manufactured (33%)
• other (please specify) (21%) - suggestions included:
  • retain forever
  • this should not be a requirement for UKRPs
  • expected lifetime of device with additional number of years as a buffer
  • lifetime of patients
  • there should be a central repository for these documents

The consultation invited views on whether the UK medical devices regulations should introduce an obligation on UK Responsible Persons to retain documentation in cases where the manufacturer has ceased activity. There were 233 responses, of which:

• 69% supported the introduction of this obligation
• 20% were not supportive
• 11% did not know or had no opinion

The MHRA asked consultees for views on whether UK Responsible Persons should be required to have at least one Qualified Person that is permanently and continuously at their disposal (available for contact at all times). There were 235 responses, of which

• 63% thought that this requirement should be introduced
• 29% were not supportive
• 9% did not know or had no opinion

12.2 The government response

The government notes that the majority of respondents supported the proposal that the regulations should include an explicit requirement for the UK Responsible Person to have an address in the UK at which they are physically located and therefore we intend to proceed with the proposal. As described in the consultation, we are aware that, in some cases, persons located outside the UK have been able to act as UKRPs by uploading a “forwarding address” to the registration system. We believe that proceeding with the above proposal will help address this issue by clarifying in the regulations that this practice is not permitted and will ensure that the MHRA has a UK-based point of contact for all medical devices placed on the market.

Having taken account of consultation feedback, the government intends to proceed with the proposal to clarify that the UKRP is legally liable (responsible or answerable in law) for defective medical devices on the same basis as the manufacturer, subject to further consideration on how this would operate in practice.

After careful consideration of responses, it remains the government’s intention to proceed with the proposal to include in the UK medical devices regulations a requirement for manufacturers and UKRPs to draw up a legal contract, subject to further consideration on how this would operate in practice.

After careful consideration of responses, it remains the government’s intention to proceed with the proposal to include in the UK medical devices regulations a requirement for manufacturers to draw up a changeover agreement when changing their UKRP subject to further consideration on how this would operate in practice.

For implantable medical devices, having considered the differing views of respondents, the government intends to introduce a requirement for UKRPs to retain or have access to technical documentation relating to such devices for the expected lifetime of a devices after the product has last been manufactured or 15 years (whichever is longer). These timings received significant support from consultees and this approach will help ensure that sufficient support is available in the event of adverse incidents occurring in these long-lived devices.

For non-implantable medical devices, having considered the differing views of respondents, we intend to introduce a requirement for UKRPs to retain technical documentation relating to such devices for the expected lifetime of a device after the product has last been manufactured or 10 years (whichever is longer). As above, these timings were supported by consultees, and this approach will help ensure that sufficient support is available in the event of adverse incidents occurring in devices that have long in-service lives.

The government intends to amend the UK medical devices regulations so that they require the UKRP to retain this documentation for the same time periods, as outlined above for implantable and non-implantable devices, in circumstances where the manufacturer has ceased activity - for example due to liquidation. We consider that this approach will aid the MHRA’s investigations of a medical device in cases where the manufacturer is no longer in operation.

The government intends to introduce a requirement for UKRPs to have a Qualified Person permanently and continuously at their disposal, subject to the outcome of further consideration on how this would operate in practice.

Section 13 - Obligations of importers and distributors

13.1 Proposals and feedback

The consultation invited views on a number of obligations that could be introduced for importers and distributors of medical devices, to support better accountability, transparency and safety. Further detail on these requirements is set out in the consultation document.

In relation to the proposals to introduce obligations on importers and distributors of medical devices, 213 responses were received, of which:

• 69% supported the requirements listed in the consultation
• 3% were not supportive
• 23% specified ‘other’
• 3% did not know or had no opinion

A wide range of views were expressed by respondents that selected ‘other’, with many signalling that they agreed or broadly agreed with the proposed requirements. The remainder of responses disagreed with one or more of the proposed requirements. The rationale for this feedback included a view that some requirements should only apply to high-risk devices, and that the requirements may be onerous for importers and distributors to adopt. In addition, some respondents expressed concern regarding the ability of importers and distributors to ensure that the end user does not receive a time expired device, suggesting that this requirement should only apply to stock that is within the control of the importer or distributor.

The consultation also invited views on the introduction of importer and distributor requirements in the abridged consultation (Chapter 17). Here 53 responses were received, of which:

• 92% supported the introduction of requirements set out in the consultation
• 6% were not supportive
• 2% did not know or had no opinion.

In terms of rationale, respondents reasoned that any requirements for importers and distributors should mirror those that apply to manufacturers and that this approach would generate safety benefits. Other respondents expressed concern about bureaucracy and possible supply issues and the capacity of importers and distributors to perform these functions. There were also calls to align requirements with those in the EU MDR/IVDR.

Respondents to Chapter 3 were asked to outline any other requirements which should be introduced for importers and distributors. There were 115 free text responses, of which 41% did not specify any further requirements or gave an unrelated response. Clear definitions of roles and responsibilities for importers and distributors were requested by 17% of respondents, and a further 7% called for alignment with the EU regulations generally, while 4% suggested that the proposed QMS requirements should utilise ISO standard 13845.

We asked whether the UK regulations should clarify that fulfilment service providers should be regarded as importers under the UK regulations. There were 218 responses, of which:

• 44% were in favour of this approach
• 28% were not in favour
• 28% did not know or had no opinion

The consultation invited views on whether economic operators (including manufacturers, importers and distributors) should be required to inform the MHRA if they become aware of any issues that will interrupt supply or cause a shortage of medical devices on the UK market. This could include, for example, shortages of critical components, operational issues at factories or supplier plants arising from floods or earthquakes, or quality issues requiring recall or rework. There were 218 responses, of which:

• 50% were in favour
• 35% were not in favour
• 15% did not know or had no opinion

Respondents were asked to provide their reasoning (including any available relevant evidence) to support their answers to the previous questions on obligations for importers and distributors, including any impacts on them or other stakeholder groups. There were several themes identified in the responses, as summarised below:

• regarding the requirement to notify the MHRA of issues that could cause interruption to supply of devices within the UK, some respondents noted that clear definitions would be needed, including for ‘critical product’ and ‘supply shortage’, while others suggested that only critical and/or unique device shortages should be reported
• there was a mixed response on the MHRA’s role in monitoring supply, with some consultees in support of this and others asserting that the MHRA should not have a role here
• some respondents suggested that only critical and / or unique device shortages should be reported
• there was also some suggestion that document retention timescales should be proportionate to the device risk class

Mixed views were expressed regarding the requirements that should apply to fulfilment service providers (FSPs). Here a number of respondents raised concerns about possible duplication of importer requirements, for example leading to dual importer labelling and registration with the MHRA. Some respondents suggested that the obligations should be based on the role of the FSP within the supply chain (meaning, importer obligations should apply in the event that the FSP is importing a device and distributor requirements should apply if the FSP is distributing a device).

13.2 The government response

The consultation set out a number of obligations on importers and distributors that could be introduced. After careful consideration of all responses, the government intends to proceed with the proposal to introduce obligations on importers and distributors, as outlined in the consultation. We will give further consideration to the concerns raised regarding the ability of importers and distributors to ensure that the end user does not receive a time expired device. We consider that this approach will improve device traceability, helping to ensure the safe supply of medical devices to the UK market. Some respondents indicated that additional guidance may be necessary to clarify the roles and responsibilities of importers and distributors, and the government intends to produce supplementary guidance on the regulatory requirements.

Regarding the regulation of fulfilment service providers, as noted above, some consultees highlighted important concerns regarding the proposal to treat all FSPs as importers citing, for example, risks of setting duplicative labelling and registration requirements. Having taken this feedback into consideration, the government intends to adjust its position and to clarify in the regulations that FSPs will fall within the scope of the definitions and need to meet the requirements of ‘importers’ or ‘distributors’ depending on their role in the supply chain. We consider that this approach will help mitigate the risks of duplication, while improving device traceability, supporting compliance activity and ensuring the safe supply of medical devices to the UK market.

After careful consideration of consultation responses, the government intends to proceed with the proposal to require economic operators to inform the MHRA if they are aware of any issues that will interrupt supply or cause a shortage of medical devices on the UK market. The MHRA will take account of consultation feedback regarding the need to set clear requirements and intend to publish supplementary guidance, alongside the regulatory changes, that will address these points.

Section 14 - Qualified Persons

14.1 Proposals and feedback

The consultation invited views on whether the UK medical devices regulations should be amended to require that manufacturers have available within their organisation at least one Qualified Person with qualifications or regulatory experience that exceeds minimum standards (which would be set out in the regulations), in the field of medical devices / in vitro diagnostic medical devices. This could include, for example, a formal qualification in law, medicine, pharmacy, engineering or another relevant scientific discipline, or sufficient professional experience in regulatory affairs or in Quality Management Systems relating to medical devices. There were 240 respondents, of which:

• 83% were in favour of introducing such a requirement
• 13% were not in favour
• 4% did not know or had no opinion

When asked what qualifications and/or experience the Qualified Person should have in order to be eligible for this role, 148 respondents provided a range of views. There was strong support for reflecting in the UK regulations, the ‘Person Responsible for Regulatory Compliance’ requirements set out in the EU MDR and IVDR.

The consultation asked whether small and medium-sized enterprises (SMEs) should be excluded from the above proposed requirements and instead be required to have a Qualified Person ‘permanently and continuously at their disposal’. There were 236 responses, of which:

• 69% were in favour of such an exemption
• 15% were not in favour
• 16% did not know or had no opinion

159 respondents provided reasoning to support their answers to the questions on Qualified Persons, including any impacts on themselves or other stakeholder groups. The following themes were raised:

• requirements should align with the EU MDR/IVDR
• consideration of alternative terminology is needed to avoid confusion with Qualified Person requirements for medicines
• the regulations should allow the Qualified Person to be based outside the UK to avoid duplication with EU MDR/IVDR requirements (as many manufacturers will have already appointed a Person Responsible for Regulatory Compliance in the EU to meet MDR requirements)
• costs / burdens may be prohibitive for SMEs
• the proposed requirements will improve safety
• need to consider capacity issues and the number of Qualified Persons that will be available to manufacturers
• clarity is needed regarding the meaning of ‘permanently and continuously at their disposal’ and ‘small and medium-sized enterprise’

14.2 The government response

After careful consideration of responses, it remains the government’s intention to proceed with the proposal to require that manufacturers have available within their organisation at least one Qualified Person with qualifications or regulatory experience that exceeds minimum standards that would be set out in the UK medical devices regulations in the field of medical devices / in vitro diagnostic medical devices.

The government will take into consideration the need for international alignment as these proposals are further developed and will also consider the points raised by respondents around capacity and terminology. The government intends to further clarify in guidance, the requirements that will apply to Qualified Persons.

It is the government’s intention to require that SMEs have a Qualified Person permanently and continuously at their disposal as this will ensure that all manufacturers will have appropriate regulatory support available to them. The government considers this to be a suitable compromise for SMEs and will avoid the need for them to directly appoint a Qualified Person to their workforce. In response to consultation feedback, we will provide further guidance on this requirement to accompany the regulatory changes.

Section 15 - Cases in which obligations of manufacturers apply to other economic operators

15.1 Proposals and feedback

The MHRA consulted on clarifying the circumstances in which an economic operator, other than the device manufacturer, would be required to assume the responsibilities of the manufacturer. There were 214 responses, of which:

• 93% thought these circumstances should be clarified
• 3% did not support this approach
• 5% did not know or had no opinion

The consultation invited views on whether the UK medical devices regulations should be amended to clarify the circumstances in which an economic operator would not be required to take on the responsibilities of a manufacturer. Out of 213 respondents:

• 84% supported this approach
• 9% were not supportive
• 7% did not know or had no opinion

The consultation asked whether the UK medical devices regulations should outline the requirements that economic operators would need to meet in circumstances where they have made a modification to a device, without taking on the obligations of the manufacturer, as set out in the consultation. 213 responses were received, of which:

• 88% were in favour of this proposal
• 6% were not in favour
• 6% did not know or had no opinion

The consultation asked respondents to set out any reasoning for their responses to the above questions. Here, 138 responses were received, which can be summarised as follows:

• further clarity is needed on the above requirements and potential impacts on health institutions
• some respondents suggested that there is a need to align with the EU MDR/IVDR
• some respondents suggested that modifications could be addressed through contractual arrangements between the manufacturer and ‘modifier’ and covered in manufacturer’s QMS
• cases in which the economic operator translates accompanying information into English could potentially have safety implications if not undertaken by a person with relevant qualifications or expertise

15.2 The government response

After careful consideration of responses, it is the government’s intention to proceed with the proposal to amend the UK medical devices regulations to clarify the circumstances in which an economic operator other than the device manufacturer would and would not be required to take on the responsibilities of the manufacturer. This will bring greater clarity to this area, where there is currently some ambiguity.

The government also intends to proceed with the proposal to amend the UK medical devices regulations to outline the requirements that economic operators would need to meet in circumstances where they have made a modification to a device, and they have not taken on the obligations of the manufacturer. We have noted the consultation feedback proposing that this could be addressed via contractual arrangements between the manufacturer and ‘modifier’ but the government