Consultation outcome

Chapter 9 - In vitro Diagnostic Medical Devices

Updated 26 June 2022

The consultation proposed amendments to the UK medical devices regulations to reflect new developments within the field of in vitro diagnostics. The proposed amendments to our regulatory framework for in vitro diagnostic medical devices (IVDs) will enable us to keep pace with fast-moving developments and innovation and will bring our approach into line with current international standards.

The aim of these proposals is to update the regulations in this area, bringing significant improvements in patient safety and to ensure more robust pre- and post-market requirements for IVDs.

Section 53 – IVD Classification Rules

53.1 Proposals and feedback

The consultation invited views on whether the classification rules for IVD products under the UK medical devices regulations should be amended to align to the EU approach to IVD classification, as set out in the EU IVDR. Of 138 responses:

• 80% supported the proposal
• 13% did not support the proposal
• 7% did not know or had no opinion

The MHRA asked consultees whether the classification rules for IVD products under the UK medical devices regulations should be amended to align to the International Medical Devices Regulatory Forum (IMDRF) approach to IVD classification. Of 136 respondents:

• 56% supported the proposal
• 20% did not support the proposal
• 24% did not know or had no opinion

The consultation invited views on whether the current IVD regulatory requirements for each class of IVD are proportionate to their risk. Of 135 responses:

• 21% felt they are proportionate
• 57% felt that they are not proportionate
• 21% did not know or had no opinion

When asked whether the current approach to classification sufficiently covers the digital/software aspect of IVD, 136 respondents provided views, of which:

• 11% felt the current approach is sufficient
• 51% felt that the current approach is not sufficient
• 38% did not know or had no opinion

We invited respondents to provide reasoning for their responses to questions in Section 53. 96 responses were received, which can be summarised as follows:

• many respondents indicated that alignment with the EU would provide economic and operational benefits to manufacturers
• some respondents note that global harmonisation (both in the context of the EU and the IMDRF) would provide wider choice to patients
• global harmonisation (both in the context of the EU and the IMDRF) would make the UK a more attractive destination to manufacturers
• clear definitions need to be provided to ensure regulations are interpreted consistently
• many respondents felt that mirroring a risk-based approach to classification would be favourable
• software must be more clearly defined in IVD regulation (see Chapter 1 on scope of the regulations)

53.2 The government response

After careful consideration of responses, it remains the government’s intention to proceed with the proposal to amend the UK medical devices regulations to amend the IVD classification rules to increase the level of scrutiny applied to IVDs, using a series of rules which align the UK more closely with the structure used by the IMDRF. This will support global harmonisation efforts and assist in providing a risk-based approach to classification of IVDs.

Section 54 – Genetic Testing

54.1 Proposals and feedback

The consultation invited views on whether the UK should introduce requirements around the information and data provided to individuals on the nature, significance, and implications of genetic tests. Of 114 responses:

• 81% supported the proposal
• 7% did not support the proposal
• 12% did not know or had no opinion

When asked whether the UK medical device regulations should be amended to align with the EU approach to the classification of genetic tests as set out in the IVDR, 116 respondents provided views, of which:

• 72% supported the proposal
• 14% did not support the proposal
• 15% did not know or had no opinion

When invited to provide reasoning for their responses to questions on genetic testing, consultees made a range of comments, which can be summarised as follows:

• the scope of the regulations should be expanded to include ‘direct-to-consumer’ testing
• aligning with the EU would provide greater clarity for both patients and manufacturers
• clearer guidance documents are required on the regulations for genetic testing

54.2 The government response

Having carefully considered consultation responses, it is the government’s intention to amend the regulations to require that the individual being tested or, where applicable, his or her legally designated representative is provided with relevant information on the nature, the significance, and the implications of the genetic test, as appropriate.

The consultation responses reflected the need for greater scrutiny to be placed on genetic tests. The new IVD classification system will classify genetic tests proportionate to their risk - i.e., where there is a risk that an erroneous result could lead to a serious adverse event, these genetic tests will be classified as Class C (second highest risk category). This reflects responses that advocated alignment with the EU IVDR (Class C) while ensuring that the risk classification is proportionate to the risk presented by a particular device. This approach will ensure that genetic tests are subject to greater regulatory scrutiny in accordance with their risk. Following specific concerns raised about direct- to- consumer genetic testing, the government will ensure that genetic tests put into service in the UK are regulated in a way that is proportionate to their risk under the new provisions.

Some respondents also indicated that more guidance may be necessary to clarify the application of genetic testing regulation. The government aims to further clarify the requirements placed on manufacturers in published guidance.

Section 55 – Companion Diagnostics

55.1 Proposals and feedback

The consultation invited views on whether Companion Diagnostics should be treated differently to other IVDs (with respect to classification). Of 110 respondents:

• 39% supported the proposal
• 40% were unsupportive
• 21% did not know or had no opinion

When invited to comment on possible methods for ensuring that the clinical evidence requirements for Companion Diagnostics are clear, appropriate and proportionate to the risk, 64 respondents provided a range of views, which can be summarised as follows:

• the MHRA needs to provide clear guidance on all Companion Diagnostic products
• clinical evidence requirements should be set, using a risk-based approach to ensure they are proportionate to the products intended use.
• clinical evidence requirements should ensure products are tested on a diverse population
• some respondents felt there was benefit in aligning with the EU IVDR
• many respondents felt there was benefit in aligning to the IMDRF’s risk-based approach

55.2 The government response

After careful consideration of responses, the government’s intention is to proceed with the proposal to amend the UK medical devices regulations to introduce classification rules specifically for Companion Diagnostic devices. In the development of these rules, we will take into consideration the approaches taken by both the EU and IMDRF. Respondents supported using a risk-based approach to clinical evidence requirements and considered that differentiation according to whether a Companion Diagnostic device is used to predict treatment benefit or toxicity alone would be overly simplistic. The government intends to proceed with a risk-based approach to the clinical evidence requirements relating to companion diagnostics, this risk-based approach will also be reflected in the classification rules.

Some respondents also indicated that more guidance may be necessary to clarify clinical evidence requirements for Companion Diagnostics. The government aims to accompany each of the IVD classifications with guidance to provide clarity on this.

Section 56 – Distance Selling

56.1 Proposals and feedback

The consultation asked consultees whether it should be made clearer that providers of testing services who supply IVDs to the UK market (through electronic or other distance sale methods), are subject to the same requirements of the UK medical device regulations that apply to economic operators in the traditional supply chain. Of 108 respondents:

• 91% supported the proposal
• 7% did not support the proposal
• 2% did not know or had no opinion

The consultation asked whether those selling testing services, which include the provision of IVDs into the UK should be required to register their medical devices with the MHRA. Of the 106 responses:

• 93% supported the proposal
• 6% did not support the proposal
• 1% did not know or had no opinion

When asked to set out their reasoning for their responses to the above questions, 63 respondents raised a number of points, which can be summarised as follows:

• if an IVD is supplied on the UK market the same rules should apply irrespective of how it is supplied
• ensuring distance sales are appropriately regulated would protect patients
• aligning with international approaches will benefit manufacturers from an economic and operational perspective
• regulations should not only apply to test kits, but should apply to services such as single site assays undertaken outside of the UK for UK samples

56.2 The government response

Having considered the views of respondents the government is minded to explore further, the scope to proceed with the above proposals and will have further cross-government discussions to ensure our approach aligns, where appropriate, with similar measures in place for other products placed on the UK market. See Section 9 in the Economic Operators Chapter (Chapter 4) and section 59 of the Software as a Medical Device Chapter (Chapter 10) for further details on Distance Sales.