Consultation outcome

Chapter 15 - Transitional Arrangements

Updated 26 June 2022

The consultation considered a number of ways in which new requirements for medical devices could be phased in, depending on, for example, the device type or the level of risk it presents (its classification).

A phased introduction of the new requirements would ensure that there is a proportionate approach to implementation, recognising that the medical devices sector requires time to make the necessary changes. This approach would minimise risks to patients and ensure the continued safe supply of devices to the UK market. It would also mean that clinical investigations devices that are underway at the point of transition would be able to continue uninterrupted.

Section 74 - Transitional Arrangements

74.1 Proposals and feedback

The MHRA consulted on a number of transitional arrangement possibilities, which could work alone or in combination, as outlined below. This would assist with the smooth transition between the current and new regulatory framework and support the ongoing safe supply of essential medical devices to the UK market.

Options 1 and 2 considered whether medical devices and in vitro diagnostic medical devices (IVDs) already lawfully placed on the market with a valid UK Conformity Assessed (UKCA) certificate/declaration of conformity (Option 1) or CE certificate/declaration of conformity (Option 2) before 1 July 2023 should be able to remain on the market after this date and for how long:

Option 1: for certification/declarations of conformity for medical devices certified before the future framework applies: medical devices and IVDs lawfully placed on the market with a valid UKCA certificate/declaration of conformity before 1 July 2023 can remain on the market until the expiry date of that UKCA certificate/declaration of conformity or until a specified date - whichever is the earliest. After the expiry of the certificate/declaration or after the specified date, devices that were placed on the market in accordance with those certificates/declarations could continue to be supplied for a further period, for example one additional year beyond the specified date.

Option 2: for certification/declarations of conformity for medical devices certified before the future regime applies: medical devices and IVDs lawfully placed on the market with a valid CE certificate/declaration of conformity before 1 July 2023 can remain on the market until the expiry date of that CE certificate/declaration of conformity or until a specified date, subject to a light touch assessment that those devices meet the necessary regulatory standard. After the expiry of the certificate/declaration or after the specified date, devices that were placed on the market in accordance with those certificates/declarations, could continue to be supplied for a further period, for example one additional year beyond the specified date.

The consultation invited views on the introduction of the transitional arrangements for UKCA certificates/declarations of conformity, as set out in Option 1 above. Of the 258 responses received:

• 68% were in support of Option 1
• 17% were not in favour of Option 1
• 15% did not know or had no opinion

Those who responded as part of an organisation were slightly more strongly in favour of the proposal (70%), versus 61% of individual respondents.

The consultation invited views on the introduction of the transitional arrangements for CE certificates/declarations of conformity, as set out in Option 2 above. Of the 255 responses received:

• 68% were in support of Option 2
• 18% were not in favour of Option 2
• 14% did not know or had no opinion

Consultees were asked to provide reasoning for their previous responses in this section and 166 responses were received. Those who were in support of either of the two above options for transitional arrangements reasoned that the options would allow for as many products as possible to continue to be placed on the market whilst manufacturers adapt to the requirements of the new regulations, noting that this approach would ensure market access and device availability.

Many respondents, both in favour of or unsupportive of these options, noted that allowing sufficient time to transition is key (as evidenced in the introduction of the EU MDR and EU IVDR) and that this approach is fundamentally linked to Approved Body capacity.

More clarity was requested around what a light touch assessment would involve in Option 2 and whether it would add any value. Respondents commented that a risk-based approach to transition would be the most beneficial for market supply.

Options 3 and 4 (set out below) briefly laid out possible transitional requirements for device registrations (Option 3) and Approved Body designations (Option 4). Questions on these options were posed in Chapters 4 and 5 of the consultation. For more information on the responses to these options please see the relevant Chapters above.

Option 3: device registration requirements would be phased in according to the risk classification of a device and UDI requirements would be introduced over time, including for devices already on the market.

Option 4: Approved Body designations are expanded on in Chapter 5. The MHRA wants to amend the UK medical devices regulations to set out that Medical Device and Active Implantable Medical Device Approved Body designations issued prior to July 2023 will be ‘rolled over’ until expiry of the designation.

Option 5 covered transitional arrangements related to clinical investigations as laid out below.

Option 5: Clinical Investigations which commence under the existing regulations before 1 July 2023 would continue to be conducted from 1 July 2023 providing that any additional reporting requirements laid out in the future regulations for clinical investigations that commence on or after 1 July 2023 are met, such as around serious adverse events or device deficiencies.

The consultation invited views on whether the transitional arrangements suggested in Option 5 should be introduced. Of the 251 responses:

• 63% supported the ‘Option 5’ proposal
• 8% were not in support of this proposal
• 29% did not know or had no opinion

The consultation asked consultees to provide reasoning for their response to the previous question. 102 responses were received. Of those who were supportive of this proposal, many reasoned that it would be impractical to impose a timeline or cut off for a clinical investigation submitted and approved before 1 July 2023 and that accepting studies that have already been submitted would prevent unnecessary disruption, allowing the UK to remain attractive for clinical investigations and maintain clinical investment in the UK, and support innovation.

The consultation asked consultees to set out any other transitional arrangements or considerations that they considered necessary for putting in place a future regime for medical devices in the UK. 109 responses were received. Respondents noted the need for an adequate transition period, the need for increased Approved Body capacity and highlighted the importance of having clear guidance in addition to the regulations on transitional arrangements.

Consultees were asked for how many years after 1 July 2023 the MHRA should accept UKCA certificates/declarations of conformity (Option 1) issued before 1 July 2023. Of the 226 responses:

• 15% selected ‘for a further 2 years’ (until 30 June 2025)
• 47% selected ‘for a further 3 years’ (until 30 June 2026)
• 38% selected ‘other’

Those that responded with ‘other’ were able to specify further and the majority were in favour of the MHRA accepting UKCA certificates/declarations of conformity issued before 1 July 2023 for a further 5 years (until 30 June 2028). A small minority responded with “until certificate expiry”.

Respondents were asked for how many years after 1 July 2023 should the MHRA accept CE certificates/declarations of conformity (Option 2) issued before 1 July 2023, with the responses as follows:

• 18% selected ‘for a further 4 years’ (until 30 June 2027)
• 49% selected ‘for a further 5 years’ (until 30 June 2028)
• 33% selected ‘other’

Of the ‘other’ responses, there was no one clear majority view, but comments included a suggestion that the MHRA should accept CE certificates/declarations of conformity issued before 1 July 2023 until certificate expiry, and a suggestion that this should be accepted for 3 years (until 30 June 2026).

The majority of those who supported the longest time period for transition (3 years for UKCA certificates and 5 years for CE certificates) reasoned that the longer the transition, the greater the chance of compliance and effective change control. Some respondents commented that the timeframe for accepting UKCA certificates should be the same as CE certificates to allow manufacturers sufficient time to transition. Many respondents also expressed concern regarding the lack of Approved Body resource and capacity and the impacts that this could have on meeting relevant deadlines.

Respondents were asked to select from a list of options regarding how long after the expiry of the certificate/declaration of conformity or after the ‘specified date’ devices covered by the transitional options 1 and 2 should be permitted to be supplied to the UK market, with responses as follows:

• 6% of respondents selected ‘6 months’
• 69% of respondents selected ‘12 months’
• 25% of respondents selected ‘they should not be permitted to be supplied after the cut-off date’

The majority of those who supported a 12-month transitional period reasoned that this time period would allow a steady distribution of medical devices to users and would be likely to reduce interruptions in supply.

Respondents were asked to outline what additional checks, if any, they would consider necessary to allow CE marked products to remain on the Great Britain market after 1 July 2023. The majority of the 140 respondents felt that no additional checks would be required, noting that the EU MDR and IVDR represent an acceptable ‘quality standard’. Others thought that the CE marking process combined with device registrations and the appointment of a UK Responsible Person would be sufficient to allow CE marked products to remain on the market after 1 July 2023.

Further comments included:

• it might be necessary for additional checks to be in place for high-risk devices
• a light touch Approved Body review could be established

74.2 The government response

After careful consideration of responses, it remains the government’s intention to introduce the transitional arrangements for UKCA marked devices, as set out below, with patient safety as the first priority. This would apply to general medical devices and IVDs that hold a valid certification/declaration of conformity to the UKCA standard, before the new regime takes full effect.

The government would like to establish a transitional arrangement for these products which will allow, at a minimum, products to be placed on the market until either the certificate expires or for three years after the new regulations take effect (in the case of general medical devices) or five years (in the case of IVDs), whichever is sooner.

The caveats that will apply to this arrangement are:

• devices that are subject to significant changes in design or intended purpose will be excluded from these provisions
• all post-market requirements applicable to the new regulatory framework will need to be complied with for all products which benefit from the transitionary arrangements

After careful consideration of responses, it is the government’s intention to put in place transitional arrangements for CE marked devices across two different categories as outlined below. We have taken account of consultation feedback on the need for appropriate transitional arrangements and propose, in certain cases, to go beyond the timescales set out in the consultation.

First, the government intends to introduce the transitional arrangements general medical devices and IVDs that hold a valid certification/declaration of conformity to the CE standard, issued under the EU Medical Devices Regulation or the EU in vitro Diagnostic Medical Devices Regulation. The government would like to establish a transitionary arrangement for these products which will allow products to continue to be placed on the market until either the certificate expires or for five years after the new regulations take effect, whichever is sooner. This will apply even if the certification/declaration of conformity is dated after the new regulations take effect. Products certified to this standard will be permitted to be placed on the Great Britain market for up to five years from the date on which the new regulatory framework takes effect, with a view to reviewing this provision at the end of the five-year period.

The requirement that the product will need to have been lawfully placed on the Great Britain market by registering with the MHRA, with the certificate/declaration of conformity issued and the product registration completed before the new regulatory framework takes full effect will not be taken forward, in light of feedback received during the consultation.

Secondly, the government intends to introduce the transitional arrangements, as set out in Option 2, for general medical devices and IVDs that hold a valid certification/declaration of conformity to the CE standard, issued under the EU Medical Devices Directive, the EU Active Implantable Medical Device Directive or the EU in vitro Diagnostic Medical Devices Directive before the regulations take effect. The government would like to establish a transitionary arrangement for these products which will allow, at a minimum, products to be placed on the market until either the certificate expires or for three years (for general medical devices) and five years (for IVDs) after the new regulations take effect, whichever is sooner. As above, the requirement that the product will need to have been lawfully placed on the Great Britain market by registering with the MHRA, before the new regulatory framework takes full effect will not be taken forward, in light of feedback received during the consultation.

The caveats that will apply to both categories of CE marked devices covered by these arrangements are:

• devices that are subject to significant changes in design or intended purpose will be excluded from these provisions
• all post-market requirements applicable to the new regulatory framework must be complied with for all products which benefit from the transitionary arrangements

The requirement that all products which benefit from these transitionary arrangements must undergo a light touch assessment that the device continues to meet the regulatory requirements will not be taken forward, due to feedback received during the consultation.

After careful consideration of all consultation responses, it remains the government’s intention to proceed with the proposal for the transitional arrangements for clinical investigations, as set out in Option 5. This will apply to clinical investigations which commence under the existing regulations before the new regulations take effect and which would not be completed before the new regulations take effect. This will not cover performance evaluations, for which we do not propose any transitional arrangements due to the significant changes to the regulatory provisions being proposed in this area.

The government would like to permit such clinical investigations to continue without a requirement to re-apply to the MHRA, on the proviso that the clinical investigation complies with all reporting requirements set out in the new regulations for clinical investigations which commence once the new regulations come into effect.

This approach will ensure that clinical investigations that straddle both regulatory frameworks will be able to continue without impediment, that clinical investigations will not be delayed from commencing if there is a risk that they will run beyond the date at which the new regulations take effect and that increased safety protocols will apply to all clinical investigations underway from the date of application of the new regulations in the form of the reporting requirements.

The arrangements laid out above will ease the transition, supporting the continuity of supply of medical devices to the UK and avoiding unnecessary duplication of resource in notifying the MHRA of activities.

All these arrangements will be temporary, with a fixed time of application in place for each of them or a point of review. On expiry of the transitionary window, all products and clinical investigations will need to comply with the UK medical devices regulations in full.