Consultation outcome

Chapter 5 - Approved Bodies

Updated 26 June 2022

The MHRA is responsible for the designation of Approved Bodies in the UK and the consultation proposals included a range of enhanced requirements for Approved Bodies, to improve transparency and ensure that Approved Bodies work to a consistent standard across the whole of the UK. This will increase patient safety through better alignment and increased scrutiny of medical devices placed on the UK market.

Section 23 – Requirements of Approved Bodies

23.1 Proposals and feedback

When asked whether the UK medical devices regulations should place more stringent requirements on Approved Bodies, as outlined in the consultation, 201 responses were received, of which:

• 73% supported the proposal
• 15% did not support the proposal
• 11% did not know or had no opinion

When asked to outline any other requirements for Approved Bodies, 109 responses were received. A number of common themes were raised, which can be summarised as follows:

• there should be requirements to ensure that Approved Bodies have the necessary technical competence
• requirements for Approved Bodies should be aligned with EU regulations
• impartiality and independence requirements should be clarified in regulations and/or guidance
• Approved Bodies should be able to provide advice relating to the correct implementation of the regulatory requirements and maintaining compliance with these
• no additional requirements should be introduced

When asked whether Approved Bodies should be able to conduct fully remote or hybrid audits of their clients in specific circumstances, out of 201 responses:

• 87% were in favour
• 7% were not in favour
• 6% did not know or had no opinion

The consultation proposed that fully remote audits could be used in specific circumstances – for example, where there are restrictions on international travel or safety concerns due to a pandemic or civil unrest. Hybrid audits, where some elements are completed onsite and others remotely, could potentially be allowed more generally.

When asked to outline any criteria that should apply to the use of remote and hybrid audits, and the expected impact of this change including any key implementation considerations that need to be considered, 84 respondents provided information, including:

• fully remote audits should only be allowed in exceptional circumstances, and should never become the norm
• Approved Bodies should be able to apply remote or hybrid audits on a case-by-case basis using a risk-based approach with appropriate justification
• a remote/hybrid approach is more efficient, and cost and time effective
• remote audits should only be allowed where information can be provided electronically, and inspection of a manufacturing site is not required
• remote audits have worked well during the pandemic and should become the norm

The MHRA sought views on options for the legal status for an Approved Body. Responses were as follows:

• a distinct legal entity based in the UK (the company as a whole) (26%)
• a distinct legal entity based in the UK or with a branch in the UK (52%)
• other (12%)
• don’t know/ no opinion (10%)

Of the respondents that selected ‘other’, 4 respondents provided information, including:

• an Approved Body should not be required to be based in the UK (3%)
• any EU Notified Body or UK Approved Body should qualify (3%)
• any CE-Approved Body should qualify (3%)
• disagreed with all options (3%)

When asked to provide reasoning to support their answers on requirements for Approved Bodies, 90 respondents provided input. Common themes can be summarised as follows:

• in order to act in the best interests of UK medical device manufacturers it would be beneficial to have legal entities that have a vested interest in the UK
• requirements on Approved Bodies should not be too restrictive to ensure that a sufficient number of Approved Bodies are available for the medical devices industry
• every aspect should be driven by quality and traceability with appropriate accountability within the UK
• these changes are in the interest of enhanced patient safety and transparency around Approved Bodies
• the Approved Body should be a distinct legal entity based in the UK, but may be a division of a larger, international organisation as is common with major international certification bodies

23.2 The government response

After careful consideration of responses, it remains the government’s intention to proceed with the proposal to place additional requirements on Approved Bodies. The requirements the government is looking to introduce are as outlined in the consultation text. There was strong support for introducing more stringent requirements on Approved Bodies, and in particular for these requirements to align with other jurisdictions.

The government is concerned about the ability of Approved Bodies to conduct on-site audits amid special circumstances, such as a global pandemic. It is the government’s view that allowing fully remote or hybrid audits in disruptive circumstances that otherwise make it difficult for Approved Bodies to conduct on-site audits, will enhance the functioning of the UK medical devices regulatory system.

In light of comments from respondents and recent experiences, the government intends to allow Approved Bodies to conduct fully remote or hybrid audits of their clients in specific circumstances. The government notes the consultation feedback that the circumstances in which hybrid or full remote audits are permitted to be undertaken should be genuinely disruptive / justified.

We consulted on whether Approved Bodies should have a distinct legal presence in the UK and a range of options for the legal status for an Approved Body were proposed. After careful consideration of responses, the government notes that the largest portion of respondents were in support of the option that would require an Approved Body to be a distinct legal entity based in the UK or to have a branch in the UK. However, requiring a UK Approved Body to have a distinct legal presence in the UK would help to ensure that the legal liability rests with the UK entity as opposed to an overseas organisation, which would help to provide clearer lines of liability for both the manufacturer and from a patient safety perspective. It is the government’s intention to proceed with the proposal to amend the UK medical devices regulations to require an Approved Body to be a distinct legal entity based in the UK. Guidance will be published to clarify the processes and procedures in this area.

Section 24 - Subsidiaries

24.1 Proposals and feedback

We sought views on whether Approved Bodies with subsidiaries should meet the following requirements:

a) publish high-level monitoring activities undertaken relating to subsidiaries

b) publish a list of subsidiaries accompanying the designated scope of the Approved Body

Out of 132 responses:

• 80% were in favour of this approach
• 6% were not in favour
• 14% did not know or had no opinion

We invited consultees to outline any other requirements which should be placed on Approved Bodies using subsidiaries. The common themes from the 53 responses can be summarised as follows:

• ensure Approved Bodies maintain alignment in expectations, interpretations, and support with their subsidiaries
• publishing a list of subsidiaries used by the Approved Body will ensure transparency to the public and clients of the Approved Body
• Approved Bodies should be fully accountable for the activities of subsidiaries

When asked to provide reasoning to support their answers to the questions on subsidiaries, 59 responses were received, and the following themes were identified:

• support for the proposals as the benefits are increased transparency and improved oversight
• requirements on Approved Bodies and their subsidiaries should align with EU MDR/IVDR as much as possible
• subsidiaries are as important as Approved Bodies, and they should be publicly known and accountable

24.2 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 provide more visibility of Approved Bodies using subsidiaries, which will include the requirement for Approved Bodies to publish high-level monitoring activities undertaken relating to subsidiaries and to publish a list of subsidiaries accompanying the designated scope of the Approved Body.

Section 25 – Approved Bodies designation and monitoring

25.1 Proposals and feedback

We asked whether the UK medical devices regulations should require Approved Bodies applying for designation to hold appropriate UK Accreditation Service (UKAS) accreditation. 180 responses were received, of which:

• 66% supported the proposed requirement
• 18% were not in favour
• 15% did not know or had no opinion

When these answers were separated between individual respondents and organisations, individuals answered the previous question as follows:

• 84% of respondents supported the proposed requirement
• 7% were not in support
• 8% did not know or had no opinion

While a lower proportion of organisations were in favour:

• 59% of respondents supported the proposed requirement
• 24% were not in support
• 17% did not know or had no opinion

When asked if the UK medical devices regulations should be amended to include new requirements for MHRA assessment of Approved Bodies, out of 180 responses:

• 82% were in favour of this proposal
• 7% were not in favour
• 11% did not know or had no opinion

As set out in the consultation, this could include a requirement for MHRA to perform a complete re-assessment of an Approved Body sooner than 5 years after designation (current requirement) where there is sufficient justification, for example, where concerns are raised regarding that Approved Body.

We invited consultees to outline any other requirements which should be introduced for MHRA assessment of Approved Bodies. 70 responses were received and can be summarised as follows:

• the regulations should retain the option for MHRA to undertake re-assessment if considered warranted in certain circumstances
• there is a need to increase the capacity of Approved Bodies in the UK
• align with requirements of EU MDR/IVDR
• unannounced audits should be introduced

We asked whether the MHRA should be able to perform remote audits of Approved Bodies or their subsidiaries in specific circumstances. 181 responses were received, of which:

• 86% were in support
• 6% were not in favour
• 8% did not know or had no opinion

We asked those who answered in support of this question to further outline any criteria that they consider should apply to the use of remote audits, and the expected impact of this change, including any key implementation considerations that need to be considered. 91 respondents provided feedback which is summarised as follows:

• remote audits should be for exceptional circumstances, and onsite audits should be the norm
• remote audits should be applied to Approved Bodies with a strong audit history
• remote audits should be considered for more circumstances, as it would have a positive environmental impact by reducing the need for travel
• there should be detailed criteria as to when remote or hybrid audits are allowed

We sought views on possible transitional arrangements, for roll over of Approved Body designations issued prior to July 2023 until expiry of the designation, with certain conditions outlined in the consultation. Of 178 responses:

• 49% supported the proposals
• 21% were unsupportive
• 30% did not know or had no opinion

When these answers were separated between individual respondents and organisations, individuals answered the previous question as follows:

• 59% were supportive
• 17% were unsupportive
• 19% did not know or had no opinion

While a lower proportion of organisations were in favour:

• 41% were supportive
• 24% were unsupportive
• 35% did not know or had no opinion

Respondents were asked to provide their reasoning for their previous answer and to expand on what they considered would be suitable criteria for this ‘roll over’ if any. 69 responses were received, and the common themes were:

• allowing Approval Bodies to roll-over designation would allow Approval Body capacity to be better managed
• the approach would minimise administrative burden during the transition phase
• most respondents agreed with a 6-month roll-over period (as set out in the consultation), and some respondents thought this could be extended to 12 or 24 months

Respondents were asked whether the MHRA should be required to perform the tasks set out below in the event of Approved Body designation withdrawal, restriction, or suspension and assess the impact on the certificates issued by the Approved Body:

• require the Approved Body to suspend or withdraw, within a reasonable period of time determined by the MHRA, any certificates which were unduly issued to ensure the safety of medical devices on the market
• ensure the certificates are marked as suspended or withdrawn on the MHRA registration system

Out of 180 respondents:

• 83% were in favour of this approach
• 4% were not in favour
• 13% did not know or had no opinion

Respondents were asked whether the UK medical devices regulations should set out the circumstances in which certificates shall remain valid on an ongoing basis or for a defined time period in the event of designation withdrawal. Out of 178 responses:

• 84% were supportive of this approach
• 4% were unsupportive
• 12% did not know or had no opinion

We invited consultees to outline any circumstances in which certificates should remain valid on an ongoing basis or for a defined time period. The common themes for the 94 responses can be summarised as follows:

• in the event that an Approved Body ceases to exist or be approved, there should be fail safes in place to protect manufacturers and the supply of devices
• certificates should remain valid for essential devices with no UKCA marked alternatives
• certificates should remain valid where the MHRA has confirmed, within one month of the suspension or restriction, that there is no safety issue in relation to certificates affected by the suspension or restriction, and has outlined a timeline and actions anticipated to remedy the suspension or restriction

When asked whether the UK medical devices regulations should introduce requirements for Approved Bodies in relation to how they conduct their activities (which could include points a-d outlined below):

• make their fees available on request to any interested party
• where they cease their activities unexpectedly, inform the MHRA and the manufacturers concerned as soon as possible
• where they plan to cease their activities, inform the MHRA and the manufacturers concerned one year before ceasing their activities
• where they have ceased their activities (planned or unexpected) take any reasonable actions to find a suitable Approved Body to take on their clients

176 responses were received, of which:

• 84% were in support of the requirements below
• 7% did not support the requirements
• 10% did not know or had no opinion

Consultees were asked to outline any other requirements which they considered should be introduced in relation to how Approved Bodies conduct their activities. Common themes raised by the 76 respondents can be summarised as follows:

• Approved Body fees and costs should be transparent and readily available
• there should be consistency across all Approved Bodies
• set timelines for assessments with suitable clock stop periods to respond to questions would be seen as a benefit and would allow greater predictability on when products can be made available

When asked to provide reasoning (including any available relevant evidence) to support their answers to all questions on Approved Body designation and monitoring, including any impacts them or other stakeholder groups, 83 responses were received. Key themes can be summarised as follows:

• these seem essential to ensure the public’s confidence in the safety of approved medical devices
• the capacity for reviewing medical devices is finite
• need to ensure the continuation of supply of medical devices in the UK
• need to support consistency and transparency in the approach taken by Approved Bodies
• implementation of the requirements must be made with clarity and efficiency

25.2 The government response

After careful consideration of responses, it remains the government’s intention to proceed with the proposal to require Approved Bodies applying for designation to hold appropriate UKAS accreditation. The processes and procedures to deliver this will be laid out in guidance.

The government also intends to proceed with the proposal to amend the UK medical devices regulations to include new requirements for MHRA assessment of Approved Bodies. This could include, for example, a requirement for MHRA to perform a complete re-assessment of an Approved Body sooner than 5 years after designation (current requirement) where there is sufficient justification e.g., where concerns are raised regarding that Approved Body.

We intend to also take forward the proposal to amend the UK medical devices regulations to provide that MHRA’s audit of an Approved Body or their subsidiaries may be conducted partially or fully remotely in specific circumstances. Based on the consultation feedback, we intend to provide that such circumstances may include situations where there are no significant concerns about the performance of an Approved Body and where at least one on-site audit has already taken place.

A transitional arrangement for the roll-over of designation was proposed in the consultation, specifically that: Approved Body designations issued prior to formal implementation date should be ‘rolled over’ until the expiry of the designation. We will proceed with this proposal. The MHRA may also assess the Approved Body to review their records, systems, procedures and processes to ensure readiness and compliance in time for the implementation date of any new requirements that will apply to these Approved Bodies with rolled over designations.

It is the government’s intention to proceed with the proposal to amend the UK medical devices regulations to provide that, in the event of Approved Body designation withdrawal, restriction, or suspension, the MHRA should be required to perform the tasks set out below:

• assess the impact on the certificates issued by the Approved Body
• require the Approved Body to suspend or withdraw, within a reasonable period of time determined by the MHRA, any certificates which were unduly issued to ensure the safety of medical devices on the market
• ensure the certificates are marked as suspended or withdrawn on the MHRA registration system

In relation to whether the UK medical devices regulations should set out the circumstances in which certificates shall remain valid on an ongoing basis or for a defined time period in the event of designation withdrawal, it is the government’s intention to proceed with the proposal as outlined in the consultation.

The consultation outlined that the UK medical devices regulations could be amended to adopt the following requirements for Approved Bodies in relation to how they conduct their activities.

1. make their fees available on request to any interested party
2. where they cease their activities unexpectedly, inform the MHRA and the manufacturers concerned as soon as possible
3. where they plan to cease their activities, inform the MHRA and the manufacturers concerned one year before ceasing their activities
4. where they have ceased their activities (planned or unexpected) take any reasonable actions to find a suitable Approved Body to take on their clients

It is the government’s intention to proceed with adopting the requirements outlined in points b, c and d. The government (alongside many respondents) is concerned about the commercial effect of requiring an Approved Body to make their fees available on request to any interested party. Based on responses received on this issue, the government intends to amend the requirement outlined in (a) to require that an Approved Body make their fees available on request by the Secretary of State.