Consultation outcome

Chapter 6 - Conformity Assessments

Updated 26 June 2022

The UK medical devices regulations set out the process that must be followed in applying for, or undertaking, a conformity assessment. The MHRA is interested in having greater transparency and consistency in conformity assessments, with the aim of ensuring that conformity assessments are carried out consistently and robustly, effectively assessing medical devices to assure their safety, quality and performance.

The purpose of the consultation in this area was to assess existing conformity assessment procedures to determine whether they require clarification or strengthening in order to ensure that the quality, safety and performance objectives laid out above are met. In the case of rarely utilised conformity assessment routes, the consultation sought to determine whether these should be removed.

1. Section 26 – Conformity Assessment

1.1 26.1 Proposals and feedback

When asked whether the conformity assessment requirements for medical devices should be clarified and strengthened for medical devices as set out in the consultation text, 244 responses were received, of which:

• 72% supported the proposal
• 18% did not support the proposal
• 11% did not know or had no opinion

Respondents made additional suggestions for requirements that could be introduced to strengthen the conformity assessment process, which are summarised below:

• aligning with international practices would bring economic and operational benefit to manufacturers by streamlining the conformity assessment process across markets
• details relating to the structure of a technical file should be covered in guidance
• devices with a risk category of IIa or above should require 100% of technical documentation to be assessed

When asked how long they felt the manufacturer should be required to keep technical documentation for a medical device they have manufactured, respondents answered as follows:

1. 1-5 years after the last product has been manufactured (6%)
2. 6-10 years after the last product has been manufactured (19%)
3. 11-15 years after the last product has been manufactured (14%)
4. for the expected lifetime of the device, after the last product has been manufactured (33%)
5. other (28%)

Responses for ‘other’ included:

• the expected lifetime of the patient using the device
• align with the EU MDR and IVDR
• the required time should be longer for implantable devices
• product lifetime plus a number of specified years. Suggestions included 5, 10 and 25 years

When asked whether certain conformity assessment routes, including batch verification, product quality assurance and type examinations, should be removed from the UK medical devices regulations, 229 responses were received, of which:

• 27% of respondents were in support of the proposal
• 36% were not in support of the proposal
• 37% did not know or had no opinion

Respondents were invited to provide reasoning for their answers to questions in this section. Key points can be summarised as follows:

• rarely utilised conformity assessment routes place strain on Approved Bodies
• small and medium-sized enterprises (SME) manufacturers benefit from having a range of routes available to them
• various conformity assessment routes provide manufacturers with flexibility even if rarely used
• additional conformity assessment options cause some confusion and clearer guidance is required
• a number of respondents were unaware that batch verification, product quality assurance and type examinations were options for conformity assessment under the current regulations or had not heard of these options at all

1.2 26.2 The government response

After careful consideration of responses, it remains the government’s intention to proceed with the proposals to:

• remove the option to use batch verification (except for Class D in vitro diagnostic medical devices (IVDs)) and type examination for all medical devices. However, for production quality assurance, this route will only be removed for class III, IIb devices and IVDs.
• improve the scrutiny placed on implantable medical devices. The future regulations will require that Class IIb implantable devices (except for sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors) will be subject to 100% review of their technical documentation as opposed to a representative review by Approved Bodies.
• require that reusable surgical instruments undergo review by an Approved Body with respect to aspects relating to the reusability of the device such as sterilisation and functional testing
• prohibit manufacturers from lodging parallel conformity assessment applications with more than one Approved Body for the same assessment
• set out a requirement in regulations that Approved Bodies must specify within their internal procedures a time limit to respond to a conformity assessment application
• require manufacturers to declare whether they have withdrawn an application with another Approved Body prior to the decision of the Approved Body they have applied to and provide information about any previous application for the same conformity assessment that has been refused by another Approved Body
• require Approved Bodies to inform other Approved Bodies and the MHRA of any manufacturer that withdraws its application prior to the Approved Body’s decision regarding the conformity assessment
• specify the required structure of a manufacturers’ technical file for a medical device

Following careful consideration of responses, the government’s intention is to proceed with the proposal to increase the document retention timescales for implantable devices to the expected lifetime of the device or at least 15 years, after the last product has been manufactured (for when the expected lifetime of the device is less than 15 years). Similarly, for non-implantable devices, the timescale for document retention will be increased to the expected lifetime of the device or at least 10 years, after the last product has been manufactured (for when the expected lifetime of the device is less than 10 years).

Having considered the views of respondents, the government notes that batch verification, product quality assurance and type examinations are rarely used and place additional burden on Approved Bodies, which can slow the assessment process overall. Given this, the government intends to proceed with the proposal to amend the UK medical devices regulations to exclude these as possible conformity assessment routes. The government acknowledges concerns raised by some respondents that this may disproportionately impact SMEs. However, we consider that the amendments listed earlier in this chapter will facilitate more effective conformity assessment through a clear route. See Chapter 14 on alternative routes to market for further details on supported market access.

2. Section 27 – Mechanism for transparency and scrutiny of conformity assessments of certain medical devices

2.1 27.1 Proposals and feedback

The consultation sought views on whether Approved Bodies should be required to notify the MHRA of certificates they have granted for medical devices with the accompanying documentation, as set out in the consultation text. 193 responses were received, of which:

• 58% were in favour of the proposed requirement
• 25% felt were unsupportive
• 18% did not know or had no opinion

The consultation invited views on whether the MHRA should apply additional scrutiny to the conformity assessment report for certain classes/types of medical devices. Out of 194 responses:

• 51% supported the proposal
• 37% did not support the proposal
• 13% did not know or had no opinion

Free-text responses detailing which types or classes of medical device this additional scrutiny should be placed on can be summarised as follows:

• class IIb implantable medical devices and above
• combination products
• software as a medical device
• all implantable devices
• a risk-based approach should be taken based on intended use

Other information provided in comments from respondents relating to the questions in Section 27 can be summarised as follows:

• MHRA should not have increased involvement in Approved Bodies’ work
• MHRA should not have increased involvement in Approved Bodies’ work unless there is a defined benefit to patients
• Approved Bodies should provide MHRA with certificates and accompanying documentation for general medical devices
• higher risk devices should have greater scrutiny on their conformance to the UK medical devices regulations

2.2 27.2 The government response

After careful consideration of the responses, the government acknowledges the support to require Approved Bodies to notify the MHRA of certificates they have granted and to require the MHRA to apply additional scrutiny to the conformity assessment reports for certain classes as outlined in the consultation. It remains the government’s intention to proceed with both proposals. However, we are considering further whether this requirement will be added to the upcoming regulations or whether it will be instead form part of a future regulatory update.

3. Section 28 – Certificates of Conformity

3.1 28.1 Proposals and feedback

The consultation invited views on whether the UK medical devices regulations should detail the minimum content of certificates of conformity, which must be provided for in English. 214 responses were received, of which:

• 87% supported the proposal
• 5% did not support the proposal
• 7% did not know or had no opinion

In the follow-up free text question, many respondents signalled their support for requiring that certificates include the data proposed in the consultation text.

The consultation invited views on whether Approved Bodies should be allowed to impose restrictions/requirements on the use/follow-up of certain medical devices as set out on the consultation. 204 responses were received, of which:

• 67% supported the proposal
• 22% did not support the proposal
• 18% did not know or had no opinion

When asked what restrictions / requirements Approved Bodies could impose, we received feedback from 103 respondents. This can be summarised as follows:

• restrictions or requirements should be limited to high-risk devices
• the risk category of the device should determine the level of Approved Body involvement
• conditional approvals or the requirements for specific post-market clinical/performance follow-up studies should be imposed but informed by clinical evidence during the conformity assessment
• allowing Approved Bodies to impose restrictions may discourage innovation and hinder supply of new products on the UK market

The consultation sought views on whether the UK medical devices regulations should require Approved Bodies to enter information about certificates into the MHRA registration system. Of the 205 responses:

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

Additional comments provided in relation to the certificate information that Approved Bodies should be required to submit can be summarised as follows:

• increasing the level of information that Approved Bodies are required to enter into the MHRA system will put strain on Approved Body resources
• requiring Approved Bodies to enter information into the MHRA database may duplicate data and workload

3.2 28.2 The government response

After careful consideration of responses and in light of the high level of support from consultees, it remains the government’s intention to proceed with the proposal to detail the minimum content of Certificates of Conformity within the regulations.

The government acknowledges both the support and the concerns expressed by respondents regarding the proposal to allow Approved Bodies to impose restrictions or requirements on the use or follow-up of certain medical devices. After careful consideration of the responses, it remains the government’s intention to proceed with the proposal, which will deliver improved patient safety and better regulatory oversight.

The government has noted the support for the proposal to introduce requirements for Approved Bodies to enter information about conformity certificates into the MHRA registration system. However, an appropriate IT system needs to be available to deliver this, which is not yet in place and the provision is therefore suspended for future consideration. In the meantime, Approved Bodies will be required to provide the MHRA with the information about certificates of conformity via an alternative route until the registration system is in place.

4. Section 29 – Voluntary change of Approved Body

4.1 29.1 Proposals and feedback

The consultation sought views on whether, in cases where a manufacturer terminates its contract with an Approved Body and enters into a contract with another Approved Body, in respect of the conformity assessment for the same medical device, the UK medical devices regulations should set out the minimum content that should be included in the agreement for a change of Approved Bodies. Of the 163 responses:

• 71% supported this proposal
• 9% did not support the proposal
• 21% did not know or had no opinion.

Respondents were invited to comment on what should be included in an agreement for a change of Approved Bodies. Feedback can be summarised as follows:

• the agreement requirements should align with the EU to allow for ease of transition
• only specific documents should be included
• this requirement would improve transparency within the conformity assessment process
• the only information required should be notifying the MHRA, as a requirement to provide further information would place additional strain on manufacturers and Approved Bodies
• having a clear agreement will ensure the transition process is smooth for manufacturers

4.2 29.2 The government response

After careful consideration of responses, it remains the government’s intention to proceed with the proposal. We are mindful of the comments made in relation to resource and capacity impacts but consider that setting out the minimum requirements in the regulations will ultimately help manufacturers and Approved Bodies plan for and execute such transfers between Approved Bodies and will standardise the approach to these transfers.

5. Section 30 – Declaration of Conformity

5.1 30.1 Proposals and feedback

The consultation sought views on whether the UK medical devices regulations should set out the minimum content requirements for the Declaration of Conformity as listed in the consultation text. Of 231 respondents:

• 91% supported this proposal
• 6% did not support the proposal
• 3% did not know or had no opinion

Respondents were invited to provide additional comments in relation to declarations of conformity, which can be summarised as follows:

• aligning with EU requirements will reduce operational burden on manufacturers
• setting out a consistent approach is useful for SMEs when producing documentation
• including all of the information listed in the consultation is useful for detailed and accurate record keeping

5.2 30.2 The government response

After careful consideration of responses and in light of the high level of support, it remains the government’s intention to proceed with the proposal to set out the minimum content requirements for the Declaration of Conformity as listed in the consultation text in order to facilitate a more consistent approach and remove ambiguity.