Consultation outcome

Chapter 4 - Registration and UDI

Updated 26 June 2022

The MHRA wants to see greater transparency in its regulation of medical devices in the UK and more traceability of medical devices across the UK. We propose to enhance transparency of information about medical devices by increasing the amount of information we capture and share about devices at the point of device registration. We also plan to introduce requirements that will help identify medical devices placed on the UK market, helping to identify and address issues with devices where they arise. These changes have the potential to help better protect peoples’ health and better inform all stakeholders, including patients and clinicians, about the medical devices in use in the UK.

Section 16 – General background

Section 16 of the consultation summarised MHRA’s ambition to be world leading in the transparency of its regulation of medical devices. It noted that historically MHRA has been limited in the information it can capture and share on medical devices and that the Medicines and Medical Devices Act 2021 contains provisions for sharing information about medical devices. This section did not contain any proposals or questions.

Section 17 - Identification within the supply chain

17.1 Proposals and feedback

The consultation outlined that the UK medical devices regulations could include a requirement for distributors and importers to cooperate with manufacturers, UK Responsible Persons (UKRPs), and public and private sector health institutions to achieve an appropriate level of traceability for medical devices. It highlighted that, for example, the regulations could be amended to require economic operators to be able to identify, record and retain the following records for a specified period of time and make these available to the MHRA upon request:

1. any economic operator to whom they have directly supplied a medical device
2. any economic operator who has directly supplied them with a medical device
3. any public or private sector health institution or healthcare professional to whom they have directly supplied a medical device
4. any lay person/user/patient directly supplied with the medical device

The consultation invited views on whether the regulations should be amended to require economic operators (manufacturers, importers, distributors etc.) to share more information with the MHRA about the supply of medical devices, and to require economic operators to ensure the appropriate traceability of medical devices. 186 responses were received, of which:

• 75% supported the inclusion of the requirements
• 20% did not support the inclusion of the requirements
• 5% did not know or had no opinion

We next asked consultees to outline other traceability requirements that they considered should be introduced. There were 132 responses. Of these, some respondents signalled support for the proposals set out in the consultation (38% of responses), with a small number indicating that they were not in favour of requiring economic operators to be able to identify and record lay person/user/patient directly supplied with the medical device. Two respondents noted that they were not in favour of any of the proposed changes set out in the consultation. No additional traceability requirements were suggested beyond those set out in the consultation. A number of respondents suggested that the requirements around the traceability of a device should align with EU MDR/IVDR (around 14%), be proportionate to device class (around 11%) and some suggested alignment with the approach of GS1 (Global Standards 1 – an international standards organisation).

Consultees were invited to specify the time period for which economic operators should be able to track the supply of medical devices and to keep the records pertaining to this, should such a requirement be introduced. There was no clear consensus among the 195 respondents who provided comments. A wide range of retention periods were suggested, with feedback including that retention periods should:

• be proportionate to device class/risk and take account of whether a device is implantable
• align with existing document retention regulations
• align to EU MDR/IVDR
• be until a device ‘expires’ (the lifetime of a medical device)
• be for the lifetime of a medical device or 10 years - whichever is longer.

When invited to provide reasoning for the responses given in this section, we received feedback from 58 respondents. Most sought alignment with EU MDR/IVDR and/or international regulation requirements more broadly, and a simple system which doesn’t duplicate other systems and is not overly bureaucratic. Commonly, respondents raised the importance of traceability for patient safety over the lifetime of a device. Few said that traceability requirements should depend on device risk class, with more traceability requirements placed on higher risk medical devices. Many felt the possible requirement that economic operators be able to identify and record any lay person or user or patient directly supplied with the medical device, is not workable and could raise UK General Data Protection Regulation (UK GDPR) issues and would amount to a patient record.

17.2 The government response

The government intends to bring in requirements for distributors and importers to cooperate with manufacturers, UKRPs, and public and private sector healthcare professionals and institutions, to achieve an appropriate level of traceability for medical devices.

It also intends to bring in requirements for economic operators to identify and record the following information:

1. any economic operator to whom they have directly supplied a medical device
2. any economic operator who has directly supplied them with a medical device
3. any public or private sector health institution or healthcare professional to which they have directly supplied a medical device

The government considers these traceability requirements are important and should apply regardless of medical device type.

The government recognises that a number of responses raised concerns about the workability of requiring information to be provided about persons directly supplied with a device and does not plan to introduce this requirement at this time but will give this more detailed consideration.

Section 18 - Nomenclature

18.1 Proposals and feedback

When asked to select which nomenclature should be required under the UK medical devices regulations for the purposes of medical device identification, the majority of respondents considered Global Medical Device Nomenclature (GMDN) to be the best option for medical device nomenclature for the UK system. 340 responses were received, of which:

• 63% were in favour of using GMDN
• 31% were in favour of using European Medical Device Nomenclature (EMDN)
• 3% were in favour of both GMDN and EMDN
• 3% said ‘other’

Comments from those who answered ‘other’ included:

• only use EMDN if interfacing with European Database on Medical Devices (EUDAMED)
• preference for one of the options set out (GMDN, EMDN, both), or no preference
• EMDN is free to access
• a new globally harmonised nomenclature should be developed
• GMDN preference as it is widely used internationally, and technically well established
• interest in harmonisation or mapping to identification numbers utilised elsewhere
• noting the cost of GMDN, and burden of moving to a different system
• regardless of which system is selected, much of industry need to work with both EMDN and GMDN across different markets

18.2 The government response

Having considered the views of respondents, the government intends to proceed with the proposal to require that manufacturers provide the MHRA with the relevant GMDN nomenclature for their medical device (including in vitro diagnostic medical devices) as part of device registration.

This nomenclature can be accessed free of charge, is already captured in MHRA’s medical device registration system, and GMDN is the most widely used nomenclature system worldwide.

The government acknowledges points raised by some respondents that EMDN is also available free of charge and allows alignment with the EU market, as well as views expressed that there is a need for a globally harmonised nomenclature system for medical devices. There is currently no global consensus on device nomenclature, so international agencies, such as the World Health Organisation, are working on standardisation of medical device nomenclature, including GMDN and EMDN. This means that some alignment will be possible in the future. However, it is the government’s view that maintaining the status quo of using GMDN nomenclature is the preferred option as it is allows for harmonisation with other major jurisdictions (although not the EU), is the current system used in the UK and avoids additional costs of moving to a new system.

Section 19 – Unique Device Identification

19.1 Proposals and feedback

The MHRA invited views on whether the UK medical devices regulations should define ‘Unique Device Identification’ (UDI). 274 respondents were received, of which:

• 91% were in favour
• 3% were against defining UDI
• 7% did not know or had no opinion

A number of respondents outlined what they considered should be included in this definition. Out of 201 free text responses, 31% were in favour of definitions used by the EU and 38% sought a modified version of the definition proposed in the consultation. There was also interest in a number of responses in alignment with UDI definitions adopted by the International Medical Device Regulators Forum (IMDRF) and the US. In a number of responses, it was suggested that the UDI definition should include definitions of ‘UDI device identifier’ (UDI-DI) and ‘UDI production identifier’ (UDI-PI) and should clarify the differences between UDI-DI, UDI-PI, Basic-UDI-DI and in some cases Unit of Use DI.

When asked whether the regulations should require manufacturers to assign UDIs to medical devices before they are placed on the market, 167 responses were received, of which:

• 83% were in favour of this requirement
• 7% were against the requirement
• 8% did not know or had no opinion

We invited those who answered ‘yes’ to this question in Chapter 4 of the consultation to further outline any particular requirements which should be introduced in regard to how UDIs should be applied to medical devices and any aspects which require clarification. Common to many of the 167 free text responses was interest in aligning requirements with the EU MDR/IVDR. A preference for alignment to the IMDRF UDI recommendations was also referenced in a number of responses. There was interest in having clear guidance, in particular for certain devices such as contact lenses, procedure packs and software devices. A number of respondents suggested that there should be a transition period for the introduction of UDI requirements. Additionally, a small number of responses indicated interest in limiting or reducing the UDI requirements that apply to lower risk devices.

We also invited views on UDI requirements in the abridged consultation (Chapter 17). We asked whether manufacturers should be required to assign UDI numbers to medical devices before they enter the UK market. Out of 53 respondents:

• 91% supported the introduction of requiring manufacturers to assign UDIs to medical devices before they are placed on the market
• 2% were not in support
• 8% did not know or had no opinion

In the abridged consultation chapter respondents to the above question were asked to provide their reasoning for their answers on UDI or any general comments on UDI requirements for medical devices. Out of the 14 responses:

• 86% were in favour of having UDI requirements for medical devices in the UK
• 14% did not know or had no opinion

In chapter 4 we also asked consultees whether we should require reusable medical devices to bear a UDI carrier (for example, a barcode) that is permanent and readable after each process on the device itself. 201 responses were received, of which:

• 70% of respondents were in favour of the requirement
• 9% were not in favour of this
• 26% did not know or had no opinion

In relation to the previous question, respondents were asked whether there should be any exemptions to this rule, and to provide examples and reasoning. Most commonly, respondents raised that there should be exemptions where it is not practical or possible to affix a UDI due, for example, to size limitations of a device. A number also suggested that direct marking requirements should not apply to software as a medical device. There was interest in having alignment of exemptions with EU and United States UDI systems, and with the IMDRF. Some respondents suggested exemptions for certain types of devices, such as custom-made devices, investigational devices, compassionate use devices, and disposable devices, for example, contact lenses. Some set out certain circumstances where they considered exemptions should apply - such as if a device is manufactured and used within the same health institution or if a device is manufactured prior to the UDI rules becoming effective.

In relation to whether the UK medical devices regulations should include requirements for Basic UDI device identifiers (UDI-DI) to identify medical device models, 266 responses were received, of which:

• 65% were in favour of such a requirement
• 18% were not in favour
• 12% did not know or had no opinion

Those in favour of this requirement expanded on their reasoning and the most common reasons given for this were that UDI requirements will improve vigilance, traceability and overall patient safety. Some expressed interest in harmonising with the EU, US and IMDRF. Other points raised related to the burden and cost this would place on industry, which could result in higher costs of devices and a need to consider exemptions to the requirements (for example, only applying the requirement to higher risk classes).

When asked if manufacturers should be required to assign and apply UDIs to their medical devices before applying to Approved Bodies for conformity assessment, 264 responses were received, of which:

• 56% were in favour of this proposal
• 26% were not in favour of this proposal
• 18% did not know or had no opinion

The consultation set out that the UK medical devices regulations could be amended to include requirements for the use of UDI and/or Basic UDI-DI in certain circumstances, including the following:

• on the Certificate of Conformity for the medical device (Basic UDI-DI) – responsibility of the Approved Body (Linked to Conformity Assessment - Chapter 6)
• on the Declaration of Conformity for the medical device (Basic UDI-DI) – responsibility of the manufacturer (Linked to Conformity Assessment - Chapter 6)
• in the patient implant information provided for an implantable medical device (UDI-DI) – responsibility of the manufacturer (Linked to Conformity Assessment - Chapter 6)
• when registering medical devices with the MHRA (Basic UDI-DI and UDI-DI) – responsibility of the manufacturer or UK Responsible Person
• when reporting serious incidents, for example, death of a patient which could have been caused by the medical device to the MHRA (UDI-DI) – responsibility of the economic operator making the report (Linked to Post-market surveillance and vigilance - Chapter 8)
• when issuing field safety corrective actions (FSCAs), for example, advising the recall of a device due to a safety issue to the MHRA (UDI-DI) – responsibility of the manufacturer (Linked to post-market surveillance and vigilance - Chapter 8)

In relation to whether the UK medical devices regulations should stipulate that the UDI or Basic UDI-DI of a medical device should be provided in the circumstances outlined above, 264 responses were received, of which:

• 78% were in favour of the proposal
• 12% were against the proposal
• 10% did not know or had no opinion

When asked to outline any other circumstances in which the UDI or Basic UDI should be provided for a medical device, 125 free text responses were received. Several respondents indicated that the circumstances should be aligned to the requirements in the EU MDR/IVDR. Examples of circumstances highlighted in which the UDI or Basic UDI should be provided, that were not covered by the list consulted on, included but were not limited to: customer complaints, within service manuals and records, within technical documentation, on implant cards, the summary of safety and clinical performance, certificates of free sale, shipping notices and Medical Device Alerts issued by the MHRA (it should be noted that these have been superseded by National Patient Safety Alerts).

When asked whether certain medical devices should be exempt from the UDI requirements, 262 responses were received, of which:

• 57% supported the proposal
• 21% did not support the proposal
• 22% did not know or had no opinion

Those who indicated in responses that certain medical devices should be exempt from UDI requirements were invited to outline which medical devices should be exempted. 119 responses raised a range of possible exemptions, including custom-made devices, investigational devices or devices for a performance study, software as a medical device, software that is app or web-based, dental crowns, low-risk devices (such as those in Class I), small devices, procedure packs, in-house manufactured devices, and prosthetic devices where it is not possible to barcode without affecting the purpose of the device. Additionally, a small number of answers raised interest in aligning with international requirements.

When asked whether manufacturers of custom-made devices should be required to assign a unique serial number to the device, 257 responses were received, of which:

• 52% were in favour of the proposal
• 19% were against this proposal
• 30% did not know or had no opinion

The consultation also asked which issuing entities should be designated by the MHRA. Respondents were asked to provide information on whether the MHRA should designate one or multiple UDI issuing entities, if there should be one issuing agency, which one and why, and if there should be multiple issuing agencies, which ones and why. There were 183 responses. Of these, the majority (66%) of respondents favoured multiple issuing entities and many of these suggested consistency with the European system (meaning, utilising the following issuing entities: Global Standards 1 (GS1), Health Industry Business Communications Council (HIBCC), International Council for Commonality in Blood Banking Automation (ICCBBA) and Informationsstelle für Arzneispezialitäten (IFA) GmbH. A further 19% of respondents favoured GS1 only, 3% respondents favoured GS1 and HIBCC, 6% gave an alternative answer and 7% did not know or had no opinion.

The consultation also asked whether manufacturers should be required to keep an up-to-date list of all UDIs they have assigned to medical devices as part of the technical documentation. Of 261 respondents:

• 80% were in favour of such a requirement
• 10% were not in favour
• 10% did not know or had no opinion

Respondents who answered in favour to the previous question were asked how long manufacturers should be required to hold this information, and to indicate whether they considered that there should be different minimum periods of retention depending upon type of device or risk classification. There was no clear consensus among the 209 responses on how long a manufacturer should be required to keep an up-to-date list of all UDIs they have assigned to medical devices as part of the technical documentation. The most common responses were in support of a retention period longer than the lifetime of the device, followed by support for retention periods being determined according to risk class, then alignment with EU MDR/IVDR requirements, and then between 6 and 10 years.

The consultation invited views on whether economic operators should be required to store the UDI numbers of certain medical devices. Of the 255 responses received:

• 68% were in favour
• 11% were not in favour
• 22% did not know or had no opinion

Respondents who answered in favour of the previous question were asked to select which groups of medical devices should fall under this requirement. The 48 respondents answered as follows:

• all implantable medical devices (77%)
• Class III implantable medical devices & Class IIb implantable medical devices (6%)
• Class III implantable medical devices (2%)
• don’t know/no opinion (15%)
• other (0%)

The consultation also asked whether healthcare professionals and/or health institutions should be required to store and keep, by electronic means, the UDIs of certain medical devices. 256 responses were received, of which:

• 70% were in favour of this requirement
• 9% were not in favour
• 20% did not know or had no opinion

Respondents who answered in favour of the previous question were asked to select which groups of medical devices should fall under this requirement. Of the 54 respondents:

• 78% selected ‘all implantable medical devices’
• 7% selected ‘Class III implantable medical devices & Class IIb implantable medical devices’
• 4% selected ‘Class III implantable medical devices’
• 7% did not know or had no opinion

The abridged consultation chapter aimed at the general public (Chapter 17), also invited views on what types/classes of medical devices should be included in the requirement for UDI storage. The 51 participants responded as follows:

• all implantable medical devices (66%)
• class III implantable medical devices (4%)
• class III and Class IIb implantable medical devices (12%)
• don’t know/no opinion (10%)
• other (8%)

Of the four respondents who selected ‘other’, responses included:

• all classes of medical devices but with the same exemptions as for EU and US: custom-made medical devices and investigational medical devices/medical devices
• option a and b, and including Class III non-implantable medical devices only
• implantable devices, infusion pumps, electrocardiogram machines (ECGs)

When asked whether the UK medical devices regulations should introduce new rules for the UDI system in order to provide clarity, 259 responses were received, of which:

• 61% were in favour of this position
• 21% were not in favour of this position
• 18% did not know or had no opinion

Respondents who answered in favour of the previous question were asked to outline what rules the UK medical devices regulations should include in regard to the UDI system. Out of the 134 free text responses, those in favour of introducing new rules for the UDI, commonly highlighted the need for clarity about what triggers a change in UDI and showed interest in aligning with EU regulations on UDI. There was also some interest in alignment with IMDRF. Others commented on the scope of what the rules should cover - such as general requirements, labelling, retention and storage, what changes result in a new UDI being assigned, rules for specific types of device (for example, where several units are packaged together, kits and system and procedure packs) and designation of issuing entities. Some of those who were unsupportive or did not know whether new rules should be included, echoed other comments such as the need for alignment with international approaches, particularly on ‘triggers’ for UDIs (to reduce the burden on the market and consequent impacts on device availability), and further responses suggested that rules should be set out in guidance rather than legislation to maintain greater flexibility.

Respondents were asked to provide their reasoning (including any available relevant evidence) to support their answers to all previous questions on UDI, including any impacts on themselves or other stakeholder groups. The following common themes were raised by 126 respondents:

• 43 called for alignment with international requirements, of which, 28 called for alignment with EU/IMDRF specifically, and the remaining suggested alignment to other international jurisdictions such as the US
• 23 expressed support for the proposed changes to UDI as they would enhance traceability, patient safety, accessibility of information and support recalls
• Several respondents expressed concerns around the regulatory burden on manufacturers, other economic operators, and clinical teams
• 7 comments related to UDI ‘triggers’, suggesting similar requirements as other jurisdictions to minimise the impact on manufacturers and global UDI systems

Respondents to the abridged consultation (Chapter 17) were also asked to provide reasoning for their answers to questions on UDI or any general comments on UDI requirements for medical devices. The following common themes were raised by 19 respondents:

• UDI requirements should be harmonised with IMDRF, EU and other jurisdictions
• support was noted for UDI for certain medical devices for enhanced traceability and patient safety

19.2 The government response

We note that there was very strong support overall for the introduction of a globally harmonised device identification and coding system which allows unambiguous identification of a specific device on the UK market. The government also acknowledges and has considered concerns raised about the introduction of UDI requirements - such as the additional burden this would bring to the medical devices industry. However, it is the government’s view that bringing in requirements for assigning and applying UDI to medical devices placed on the UK market will enhance our ability to trace medical devices and take appropriate action if issues arise with a device.

It is our intention to proceed with defining ‘UDI’ within the UK medical devices regulations. The government has carefully considered the responses on what should be included in this definition and intends to utilise a definition that allows alignment with other jurisdictions such as the EU.

After consideration of the responses on the assignment of UDIs, it is the government’s intention to proceed with the following proposals:

• to require manufacturers to assign UDIs to medical devices before they are placed on the market
• to require reusable medical devices to bear a UDI carrier (for example, a barcode) that is permanent and readable after each process on the device itself.
• to include requirements for Basic UDI device identifiers (UDI-DI) to identify medical device models

We also intend to issue clear guidance that helps the market understand the distinction between Basic UDI-DI and other forms of identifiers (e.g. unit of use DI), so that the rationale for, and value of, collecting this information is clearer.

After consideration of the responses received in relation to the assignment of UDIs before applying to Approved Bodies for conformity assessment, it is the government’s view that this requirement should not be introduced for manufacturers of all medical devices, as the traceability benefits would not be proportional to the increased work required to implement this requirement for manufacturers. However, it is our intention to introduce an amended requirement for manufacturers of class III medical devices and some class IIb implantable medical devices only to assign a Basic UDI-DI to these devices before applying to an approved body for conformity assessment, as the traceability benefits this brings are justified for these higher risk devices.

Based on the responses received, the government also intends to proceed with requiring the UDI or Basic UDI-DI of a medical device to be provided in the circumstances outlined in paragraph 19.12 of the consultation.

Additionally, in relation to other circumstances in which a UDI or Basic-UDI should be provided, the government has considered the views raised by respondents in favour of including reflecting the circumstances that are included in the EU MDR and IVDR and considers the inclusion of those circumstances to be beneficial to the traceability of medical devices in the UK. It is our intention to also require the UDI or Basic-UDI to be provided in circumstances that are aligned with those stipulated in the EU MDR and IVDR.

The government will consider further whether there are valid exemptions to UDI requirements and whether there is a need for further guidance on how UDI requirements apply to certain product groups.

We intend to designate GS1, HIBCC, ICCBBA and IFA as UDI issuing entities, as a clear majority of respondents supported this option, and it presents an opportunity to align with other jurisdictions.

The government considers that manufacturers should be required to keep an up-to-date list of all UDIs they have assigned to medical devices as part of the technical documentation and be subject to the retention periods as outlined in chapter on Conformity Assessment (Chapter 6).

After careful consideration of the responses received, it is our intention to proceed with the proposal to require economic operators and healthcare professionals and/or health institutions to store the UDI numbers of implantable medical devices, noting that the majority of respondents were supportive of this requirement.

After careful consideration of responses on proposals to introduce new rules for the UDI system, we intend to provide clarity in the UK medical devices regulations on the triggers that would result in a requirement to apply a new UDI-DI.

Section 20 – Great Britain database on medical devices

20.1 Proposals and feedback

The consultation outlined that the MHRA is considering the potential to capture and process information submitted to the MHRA about medical devices (such as device registration, vigilance and post-market surveillance, clinical investigations and performance studies) in a series of integrated databases (electronic information systems). This would enable the MHRA to bring together all the information about medical devices on the market to ensure enhanced transparency and effective market surveillance activities.

When asked whether this proposal should be introduced, out of 224 respondents:

• 78% supported the proposal
• 12% were unsupportive
• 9% did not know or had no opinion

Respondents were asked to provide their reasoning (including any available relevant evidence) to support their answer to the previous question, including any impacts on or implementation considerations for themselves or other stakeholder groups. The following common themes were raised by 198 respondents:

• responses showed overwhelming support for the development of an integrated system. Reasons given in favour included that it would be useful, would improve information gathered and allow better coordination, enhanced transparency and have a positive impact on patient safety
• many felt the approach taken to this proposal should be similar to EUDAMED
• those not in support reasoned that the approach would be burdensome for industry to implement, and that the MHRA should use EUDAMED rather than developing its own system

20.2 The government response

The government is focused on establishing a more comprehensive registration database for medical devices, which will include UDI information. We remain focused on exploring whether and how best this database can operate as part a series of integrated databases for capturing and processing information submitted to the MHRA about medical devices (such as data on registration, vigilance, post-market surveillance, and market surveillance regarding medical devices).

Section 21 – Registration of medical devices

21.1 Proposals and feedback

The consultation invited views on whether manufacturers should be required to provide the information in ‘List One’, as set out in the consultation text, to the MHRA upon medical device registration. 269 responses were received, of which:

• 55% were in support of the proposal
• 17% did not support the proposal
• 10% did not know or had no opinion
• 18% selected ‘other’

When asked to specify any changes proposed to the list of registration requirements and accompanying rationale, 148 free text responses were received. As set out below, respondents were invited to share the reasoning for their answer to this question. For those who were unsupportive of some or all of the proposed list of registration requirements, reasoning included that they felt the information already requested at point of device registration is sufficient, that the information listed is already available from other sources, that the requirement for certain information at device registration should only apply to high-risk classes of devices and/or concern about the burden on industry the requirement would bring. In addition, a number indicated that they would prefer alignment with the EU. There was no clear rationale given in favour of proposed additions to registration information required.

Respondents were asked to select which of the following entities should be permitted to submit device registration information to the MHRA (selecting all that apply). We received 213 responses as follows:

• UK Responsible Persons and UK-based manufacturers (current requirement) (90%)
• non-UK based manufacturers (65%)
• authorised third-party submitters (52%)
• all (3%)
• distributors (0.5%)

When asked what mechanisms should be in place to submit data, out of 247 responses there was strong interest in both web forms (from 93% of respondents) and machine to machine upload (from 53% of respondents). There was also interest in bulk uploads being made available.

Respondents were asked to outline the transition timeframes that they considered should apply to this additional required information. Opinions were varied amongst the 175 free text responses. The majority made reference a specific timeframe ranging from 1 month to 5 years. The highest proportion or respondents suggested a timeframe proportionate to the risk class of the device (29%), followed by 2 years (11%), 1 year (8%), 3 years (7%), and that the timeframe should align with the EU MDR/IVDR (3%).

We invited views on whether the information that the MHRA gathers at the point of medical device registration should be made publicly available, via a website of similar platform. 268 responses were received, of which:

• 65% were in support of this proposal
• 21% were not in support of this proposal
• 15% did not know or had no opinion

Those who answered in support of the previous question were asked to further outline what information should be shared and the rationale and key considerations or limitations, with 115 respondents raising the following themes:

• agree with proposal (57%)
• suggestion that only limited data should be displayed - mainly concerns around commercially sensitive data and UK GDPR (55%)
• suggest aligning with EUDAMED (10%)
• have concerns, disagree with the proposal, don’t want to publish information or are unsure of the benefit (5%)
• gave no response (7%)

When asked whether manufacturers should be required to register with the MHRA before applying to an Approved Body for conformity assessment, and for the Approved Body to verify this registration, 265 responses were received, of which:

• 40% were in favour of this proposal
• 42% were against this proposal
• 18% said they did not know or had no opinion

We invited consultees to provide reasoning for their response to the above question. Some raised objections to the proposal, including that requiring registration ahead of pre-market approval from an Approved Body would be burdensome, with potential commercial implications (such as the need to release marketing plans before approval), and, concerns that a product may change between pre-approval registration and final approval, leading to unnecessary effort to register at this point in the process.

In relation to whether economic operators should be given up to 30 days’ timeframe to update an MHRA registration record after a change has been made to a device’s registration details, 260 responses were received, of which:

• 74% were in favour of such a requirement
• 12% were against it
• 14% did not know or had no opinion

Respondents were asked to provide their reasoning to support their answer to the above question on the timeframe for updating registration records. The majority of the 158 respondents expressed agreement with the proposed ‘30 days’ timeframe, with significant support also for favouring a ‘longer timescale’ and that ‘those timescales should be proportionate to class’. Themes that emerged from the responses included concerns over getting the required information/documents from represented organisations and conformity assessment bodies, burden on industry and a desire for flexibility and extensions to deadlines.

In relation to whether the UK medical devices regulations should include a requirement for economic operators to confirm all data submitted in their registration one year after submission and then every second year thereafter (biennially), 261 responses were received, of which:

• 56% supported this proposal
• 28% did not agree with this proposal
• 17% did not know or had no opinion

When invited to expand on their reasoning for their responses to questions in this section of the consultation, objections respondents raised to having annual/biennial confirmation of registered data included that annual/biennial review for accuracy is not necessary if there is also a requirement to update registrations with any changes.

We invited views on how economic operators should be identified within the MHRA system. 212 responses were received, and responses were fairly evenly split, as follows:

• 32% in support of Data Universal Numbering System (DUNS)
• 28% in support of Global Location Number (GLN)
• 29% in support of a MHRA generated number

We invited consultees to provide reasoning for their responses to questions in this section. Limited rationale was provided, including:

• general greater registration information to improve device traceability and safety
• concern for the additional burden/proportionality of additional registration requirements
• interest in alignment with EU requirements.

21.2 The government response

The government intends to extend the data required at the point of device registration as set out in the consultation, with the following amendments.

In light of consultation feedback, the intention is not to introduce requirements for the following information to be submitted when registering a medical device with MHRA:

• periodic safety update report or post-market surveillance report with each registration renewal – and instead require this to be provided to the Secretary of State on request
• information about other countries in which the device is made available/placed on market- as it is considered a disproportionate burden on industry to collect and keep such information updated, and
• sterilisation provider - as this information is subject to change and would create a disproportionate burden to maintain

MHRA is of the view the following information should form part of information collected at the point of medical device registration, notwithstanding concerns raised with this:

• an undertaking that manufacturers have met the requirement to have measures in place for recompense for negative impacts of a medical device – we consider it important that this information is confirmed at the point of device registration
• the reference number of the clinical investigation / performance study conducted in relation to the medical device – we intend to introduce this requirement to improve the ability to cross reference data held by the MHRA

The following minor variations have been made to the information MHRA plans to collect at point of medical device registration following feedback received:

• the ‘status of the medical device’ will be revised to ‘status of availability’ (for example, ‘on the market’, ‘pre-market’, ‘withdrawn from market’)
• specification as to whether the intended purpose of the product is ‘other than a medical purpose’ - we will ensure this is ‘if applicable’ MRI safety status information – this will only apply if relevant to the device

The government will also consider further whether to require additional information regarding whether tissues or cells of human and/or animal origin, or their derivatives, are present.

The government intends to extend the list of those who can submit device registration information to give manufacturers greater flexibility in how / who can submit data, which will reduce burden on manufacturers in meeting registration requirements.

In terms of the mechanisms that could be put in place for submitting device registration information, respondents signalled significant support for web form and machine to machine mechanisms. The government will further consider these mechanisms. The MHRA is minded to ensure medical device registration information can be submitted via both web forms and machine–to–machine mechanisms. It does not consider that mechanisms for submitting data need to be prescribed in regulations but will continue to ensure that there is clear guidance on the mechanisms for providing device registration information.

The government intends to provide a phased introduction of new registration requirements, commensurate with the risk classification of a device. This will be similar to the phased approach taken to introducing new medical device registration requirements during 2021, where compliance timeframes were set in accordance with device classes.

The government intends to make all registration data publicly available to enable more informed choices around the use of medical devices, excluding personal information and commercially sensitive information, and in compliance with UK GDPR.

After consideration of the responses received, the government intends to consider further whether to introduce a requirement for manufacturers to register with the MHRA before applying to an Approved Body for conformity assessment and for the Approved Body to verify this registration. We are interested in the traceability benefits this could bring.

As supported by the majority of respondents, the government intends to proceed with its proposal for economic operators to be given up to a 30-day timeframe to update an MHRA registration record after a change has been made to registration details. The government recognises that respondents gave limited rationale for their proposed timeframes, but some references were made to the need to consider the burden on manufacturers and take an approach proportionate to risk of a device, as well as calls for alignment with the EU MDR. Taking this feedback into account, we consider that allowing 30 days to update information will ensure that the MHRA has timely, accurate information to share with the public and utilise as appropriate if an issue with a device arises.

The government also intends to introduce a requirement for economic operators to confirm all data submitted in their device registration one year after submission and then every second year thereafter. The government acknowledges that there was not strong support for this provision from respondents, and objections raised included that the introduction of a 30-day requirement to update the MHRA of any changes would be sufficient. However, it is the government’s view that ensuring the accuracy of medical device registration information is a crucial aspect of regulation and that the benefits of having in place assurances of the accuracy outweigh any concerns about additional burden to industry that an annual/biennial update would pose.

The government intends to require the identification of certain economic operators (such as manufacturers (including assemblers or sterilisers of system of procedure packs), UK Responsible Persons, importers and distributors of a medical device to register with the MHRA. We intend that when registering, these economic operators will need to be issued with a unique MHRA-generated number. In addition, if it is already held, an economic operator will be able to voluntarily provide another internationally recognised external reference (for example, DUNS, GLN, SRN).