Webinar title: The UKCA – Now, Next, Navigating Ahead
Speaker: Teresa Perry
Regulatory Affairs Expert | UKCA and UK Medical Device Regulation
Date: October 2025
Key takeaways:
- Current UKCA transition timelines
- Expected UK regulatory developments
- Impact on manufacturers and distributors
- Practical compliance planning considerations
Summary:
The UKCA marking continues to reshape market access in the UK. In this webinar, Teresa Perry explains where the UKCA framework stands today and what changes are on the horizon, as well as offering practical guidance for navigating what’s coming next.
Watch or download:
Timestamps/chapters:
- 00:53 – Session start / introduction of speaker
- 02:54 – Overview of presentation
- 04:12 – Current regulatory environment (MHRA roadmap)
- 06:34 – Post-market surveillance legislation update
- 07:22 – CE marking recognition and future direction
- 09:07 – General rules for placing devices on the GB market
- 11:02 – Post-market surveillance (PMS) requirements
- 12:38 – Alignment with EU PMS framework
- 13:38 – MHRA access timelines and legal obligations
- 14:10 – PMS planning and system structure
- 15:07 – Device lifetime and real-world data
- 15:41 – Real-world data and statistical evaluation
- 16:21 – Incident reporting timelines and systems
- 17:47 – Investigation requirements and legal considerations
- 18:26 – Field safety corrective actions
- 19:02 – Summary reporting requirements
- 20:34 – Higher-risk devices and data requirements
- 20:53 – Reporting requirements for CE-marked devices
- 24:14 – Transition to future pre-market legislation
- 27:24 – Likely elements of future UK regulation
- 29:31 – Clinical evidence and future regulatory direction
- 30:27 – International reliance
- 37:28 – Future MHRA direction, AI and regulation
- 38:39 – Artificial Intelligence
- 43:10 – Q&A and closing remarks
Full webinar transcript:
00:53 – Session start / introduction of speaker
Thank you so much for being with us today.
My first question is: Teresa, please could you start by telling us a little bit about yourself and your company?
Yeah, sure, no problem.
I am currently running Peritus Regulatory Consulting, where I specialise in quality management systems and technical documentation review and preparation.
Prior to that, I spent 23 years in two organisations that were both notified bodies, approved bodies, certification bodies, and MDSAP auditing organisations.
I spent many years auditing and training teams to deliver audits, as well as responding to regulatory non-conformities and holding technical roles such as certificate decision maker, scheme manager, and operations management roles.
In my most recent role at LNE/GMED UK as Head of the Approved Body, my team and I achieved designation against all three parts of the medical device regulation over a two-year period.
In this role, I worked extensively with the MHRA and Team-AB to help develop guidance documents and provide feedback on regulatory policy.
Team-AB is a UK advisory body similar in function to its EU counterpart.
As part of this work, LNE/GMED was also the only approved body to take an innovative device through the MHRA’s pilot Innovative Device Access Pathway.
So overall, I have extensive experience working with regulators.
02:54 – Overview of presentation
I will begin by outlining the MHRA’s progress against its roadmap, the current state of regulation, and the new PMS statutory regulation.
We will then look at what the MHRA may be planning next and how this might affect market access pathways.
Finally, we will discuss some of the challenges and uncertainties facing manufacturers and approved bodies over the coming years.
By the end of this session, you should have a good understanding of the current UKCA status, what changes you may need to build into your regulatory strategy, and how to prepare for potential uncertainties.
There is quite a lot of material, and some slides are intended as reference, so I may move through them quickly and focus on key changes.
04:12 – Current regulatory environment (MHRA roadmap)
The MHRA has published a roadmap for implementation of its regulatory reforms. This is a living document and may change.
If we go back to April 2023, we saw the extension of CE marking recognition beyond the originally planned Brexit deadline.
At that time, there was discussion about introducing a full new regulatory framework intended for rollout around 2025.
However, since then, various regulatory and political challenges have emerged, including shifting deadlines in the EU, changing government priorities, and reduced industry appetite for another major regulatory overhaul.
The conformity assessment body model is also becoming more uncertain.
As a result, the idea of a full new UK MDR-style sovereign regulation is now less likely to proceed in that form.
The latest MHRA roadmap (published in December last year) indicates a more staged approach, with 2026 now being a target for a more streamlined version of the regulation.
In the meantime, updates were required to address expiring references in retained EU law that still forms part of UK medical device legislation.
These updates removed certain expiry dates to ensure continuity.
This includes legislation such as Regulation 722/2012 relating to medical devices incorporating animal tissue.
06:34 – Post-market surveillance legislation update
Now there was another piece of legislation issued this year relating to critical elements of post-market surveillance, which the MHRA felt could not wait until 2026.
This resulted in SI 2024 No. 1368, which included a six-month transition period and came into force on 16 June this year.
As a result, 2026 is now considered the guideline date for the new pre-market statutory instrument.
We will take a deeper dive into this in the second part of the presentation.
07:22 – CE marking recognition and future direction
The UK is currently still recognising the CE mark for medical devices. However, this recognition is time-limited depending on device type and conformity route.
If you visit the MHRA website, you will find an infographic that sets out the different timelines depending on whether your device is under MDD or EU MDR conformity assessment.
It is important to always check the MHRA website directly for the most up-to-date deadlines relevant to your device.
However, MHRA has recently announced plans to consult on the indefinite recognition of CE marking later this year.
Several other areas of UK regulation have already taken a similar approach, removing fixed expiry dates in favour of ongoing recognition.
This suggests a strong possibility that CE marking recognition may continue under MDR or IVDR frameworks.
09:07 – General rules for placing devices on the GB market
There are a number of baseline requirements that apply regardless of whether you follow UKCA or CE marking routes.
For example, if you are a manufacturer based outside Great Britain, you must appoint a UK Responsible Person (UKRP).
The UKRP is responsible for:
- registering the device
- holding technical documentation in English
- acting as the contact point for vigilance
- providing regulatory information such as importer details.
A key point is that a manufacturer can only appoint one UKRP for their devices.
In addition, most devices must now be registered with the MHRA through the Device Online Registration system.
Previously, there were exemptions for certain device types, but these have largely been removed.
If you use the UKCA marking route, you must apply the UKCA mark to your product.
You must also include the name and address of the UK Responsible Person on the label, packaging, or instructions for use, depending on the device.
Another key requirement is compliance with the post-market surveillance (PMS) statutory instrument, which applies regardless of market route.
11:02 – Post-market surveillance (PMS) requirements
The new PMS statutory instrument came into force a few months ago and applies to all devices placed on the Great Britain market, regardless of whether they are UKCA or CE marked.
There are, however, some exclusions.
The legislation does not apply in the same way to:
- clinical investigations
- performance evaluations
- exceptional use authorisations
These are governed by separate reporting frameworks.
Custom-made devices are also treated differently, as they are not expected to generate large datasets for post-market surveillance.
For these devices, requirements such as PSURs may not be applicable due to the limited data available.
For all other devices, including CE marked devices placed on the GB market, PMS requirements broadly align with EU requirements, although there are some subtle differences.
12:38 – Alignment with EU PMS framework
Overall, there is strong alignment between UK PMS requirements and EU regulations, but some differences remain.
To explain this, one useful analogy is that of Class I devices.
We know that Class I devices require technical documentation, but this documentation is not routinely reviewed unless triggered by an event such as vigilance reporting.
A similar principle applies here.
Manufacturers must comply with PMS requirements, but MHRA will not routinely review PMS reports unless there is a vigilance trigger or safety concern.
In such cases, the MHRA may request access to the relevant PMS documentation.
13:38 – MHRA access timelines and legal obligations
One of the key differences between Great Britain and the EU is that the MHRA can request certain post-market surveillance information to be provided within three working days.
This is a very short turnaround time, and manufacturers need to be prepared to respond quickly.
It is important to understand that even if data is not routinely reviewed, it remains a legal requirement to maintain it.
14:10 – PMS planning and system structure
The first step in compliance is to build a PMS plan.
This plan defines:
- key objectives
- methods used for data collection
- how outputs feed into risk management and vice versa
Many PMS requirements are linked to device classification and therefore the level of risk.
This classification determines:
- how frequently PMS activities must be carried out
- whether an approved body is involved
- whether methods are proportionate to the device risk level
High-risk or novel devices require more robust methodologies compared to low-risk, well-established technologies.
15:07 – Device lifetime and real-world data
A new concept introduced in the regulation is “device lifetime”.
This refers to the period from manufacture through to the end of the expected service life, including shelf life.
If real-world data shows that actual use consistently exceeds validated use conditions, this information must not be ignored.
Instead, it should be fed back into the risk management system.
15:41 – Real-world data and statistical evaluation
Real-world data refers to data collected during normal clinical use.
MHRA expects data to be collected from multiple sources, including:
- healthcare professionals
- patients
Appropriate statistical methods should be used to determine whether any reportable trends exist.
16:21 – Incident reporting timelines and systems
Reporting timelines under the UK system are now aligned more closely with EU requirements, including:
- 2-day
- 10-day
- 15-day reporting windows depending on severity
The criteria for determining reportability are also aligned with EU MDR.
Incident reporting must be submitted through the MHRA MORE database.
Manufacturers must register and maintain an account within this system.
A new data schema is now in effect, based on an XML-compatible structure to improve consistency and analysis.
Changes include removal of UDI-related fields and addition of UKRP and UK Approved Body identifiers.
17:47 – Investigation requirements and legal considerations
If destructive testing is required as part of a vigilance investigation, this must first be discussed with the MHRA.
This aligns with Article 89 of the EU MDR.
In serious cases involving patient death, police or coroner involvement may be required, and criminal investigations are possible.
Therefore, permission must be obtained before destroying any evidence.
18:26 – Field safety corrective actions
Field Safety Corrective Actions (FSCA) and Field Safety Notices (FSN) are broadly aligned with EU requirements.
FSN documents must generally be submitted to MHRA for review before distribution.
The only exception is when immediate distribution is required for patient safety reasons.
Manufacturers should always involve MHRA where possible before issuing FSNs.
19:02 – Summary reporting requirements
For low-risk devices (e.g. Class I devices and general IVDs), only a Post-Market Surveillance report is required.
For the UK system, this report must be produced every three years.
In the EU, the requirement is more flexible and defined as “as needed”.
Even though submission is not always required, MHRA can request the report and it must be provided within three working days.
Additionally, notified bodies or auditors may also request to review these reports during QMS audits.
20:34 – Higher-risk devices and data requirements
For higher-risk devices, more detailed PMS documentation is required.
Manufacturers must collect and analyse:
- UK-specific sales data
- usage data
- incident data
- global comparisons where relevant.
Submission to an approved body is only required if the device carries UKCA marking and falls within scope.
20:53 – Reporting requirements for CE-marked devices
For CE-marked devices, manufacturers must still produce a post-market surveillance report.
However, there is no requirement to routinely submit this report to an authority.
That said, the MHRA may request it at any time, and it must be provided within three working days.
For Class IIa and IIb non-implantable devices, approved bodies may review PMS documentation but do not necessarily produce formal reports.
Their role is primarily to confirm that the system is in place and functioning appropriately.
For higher-risk devices, particularly implantables, formal reporting requirements apply.
In these cases, approved bodies will typically align PMS review with existing technical documentation assessments to avoid duplication of work.
However, there can be challenges in timing, particularly where sampling schedules do not align with PSUR cycles.
Approved bodies may therefore use additional opportunities, such as QMS audits, to review PMS documentation.
If concerns arise, such as increased vigilance reporting, approved bodies may initiate additional PMS reviews or request further information.
Trend reporting remains a key requirement.
Even if individual incidents are not reportable, an increase in frequency or pattern of incidents may constitute an adverse trend and must be reported.
Custom-made devices are generally excluded from these requirements due to limited data availability.
24:14 – Transition to future pre-market legislation
We are now up to date with the current regulatory framework.
However, new pre-market requirements are on the horizon.
It is important to note that these proposals are not yet published, so everything discussed from this point is subject to change.
The MHRA roadmap provides an indicative timeline for future legislation.
Under WTO rules, healthcare legislation must be submitted as a draft at least six months before being enacted.
The original roadmap suggested submission between May and July, but this has not yet occurred.
Following parliamentary review, implementation would typically occur with a transition period, potentially bringing enforcement into summer 2026.
However, delays to the WTO submission make this timeline uncertain.
Realistically, the earliest expected implementation would be mid to late 2026, or possibly later.
Transition periods are expected to vary depending on device type.
For UKCA-marked devices, transitional arrangements may include:
- 3 years for medical devices
- 5 years for IVDs
- or until existing certificates expire.
For CE-marked devices, transition provisions may be less relevant if indefinite recognition of CE marking continues.
27:24 – Likely elements of future UK regulation
Several elements of the upcoming legislation are highly likely.
Unique Device Identification (UDI) is expected to be included.
The MHRA is likely to avoid duplication with existing EU systems, meaning current UDI frameworks may be accepted.
Device classification updates are also expected, aligning more closely with EU structures.
This may include:
- Class I reusable devices
- implantable devices
- software as a medical device
- revised IVD classification system.
For IVDs, a shift towards A–D classification is anticipated.
One significant potential change is that Class B IVDs may become self-certified, which would represent a major departure from the EU model.
This reflects concerns that Class B devices may currently be over-regulated.
Manufacturers should therefore carefully review how their devices may be reclassified under the new system.
29:31 – Clinical evidence and future regulatory direction
Further expected changes include stronger documentation requirements, particularly relating to clinical evidence.
The MHRA has historically placed strong emphasis on substantiation of device claims.
This focus is expected to continue and may be strengthened in future legislation.
Alignment with EU requirements is also likely, particularly in relation to the General Safety and Performance Requirements (GSPRs).
In earlier consultations, there was discussion about exemptions from clinical evidence requirements for well-established technologies.
It remains unclear whether this exemption will be maintained, modified, or removed entirely in the final legislation.
This is one of the key areas to watch in the upcoming regulatory changes.
30:27 – International reliance
And I think the last area people are quite keen to hear more about is international reliance, where you can actually place your devices on the market leveraging your existing approvals.
There are definitely benefits and challenges to this approach. Some things are clear, others are still evolving, especially given recent regulatory and legal scrutiny over the past year.
The concept of international reliance is to allow medical devices already approved in other countries—where regulators have strong relationships with the MHRA—to be placed on the Great Britain market without requiring UKCA marking. The intention is to reduce regulatory burden for manufacturers while maintaining patient safety and device continuity in the UK.
Comparable regulators currently being considered include the USA, Australia, and Canada. The EU has been set aside in this context, as the direction there is closer to full recognition rather than reliance. Other regulators, such as Japan, may be added in the future.
A certificate would likely still be issued, but it would be a certificate of international reliance rather than a UKCA certificate, typically issued by approved bodies.
There are still common baseline requirements regardless of route. Devices must fall within the scope of UK MDR, be correctly classified under UK rules, have English labelling, and require a UK Responsible Person if the manufacturer is outside the UK. Registration with the MHRA, UDI requirements, PMS obligations, implant cards where relevant, and other UK-specific standards also still apply.
However, the level of additional scrutiny will vary. Some routes, especially those closer to full recognition, may involve minimal additional requirements, while others, particularly those based on predicate approvals such as US 510(k), may trigger more conditions or even exclusions. In higher-risk cases, manufacturers may need to provide clinical data, software lifecycle documentation, change control plans, implant cards, or PSURs.
There are also exclusions, such as certain in-house or custom devices and other defined categories, meaning manufacturers must assess carefully whether their product qualifies.
Overall, the system is still evolving, and many details remain subject to change.
37:28 – Future MHRA direction, AI and regulation
Looking further ahead, the MHRA is expected to focus heavily on implementation work after the new legislation is launched, including redesignating approved bodies and producing extensive guidance.
A common criticism has been that legislation is released before full guidance is available, making implementation harder for industry. As a result, significant effort is now going into producing detailed guidance, particularly for reforms expected next year.
A major area of development is AI and software regulation. This is widely recognised as a growth area, and multiple working groups are actively exploring it. Initiatives such as the AI Airlock are being used to test regulatory approaches and define appropriate control mechanisms, since AI development does not always fit traditional medical device pathways.
Initial outputs are expected in the form of guidance, which may later evolve into formal legislation once approaches become more established. There is also ongoing alignment work with broader frameworks such as the EU AI Act.
Other potential future areas include products without a medical purpose and further refinement of clinical equivalence rules, which may start as guidance before becoming formal regulation.
The MHRA also aims to position the UK as a hub for innovation, supporting faster approval pathways such as IDAP and collaborative international programmes in oncology and other fields to accelerate patient access.
A key challenge remains the capacity of approved bodies. Increased demand, rising designation costs, and limited resources may create bottlenecks, making early engagement with regulatory bodies increasingly important for manufacturers planning market access.
Overall, the direction is toward greater international cooperation, reduced duplication, and simplified market access, while still balancing safety and regulatory robustness.
38:39 – Artificial Intelligence
I think we all recognise that this is an area of growth.
I think you may have seen information on the AI Airlock project, which is working to establish control mechanisms for AI because its development differs from traditional medical devices.
We can expect initial guidance first, with the possibility of later incorporation into legislation as confidence grows in regulating AI and software.
There is also integration work with the EU AI Act, which adds further complexity.
Other areas currently seen as lower priority may become more important later, such as non-medical products without a medical purpose (similar to EU Annex XVI devices).
A key uncertainty is clinical equivalence, which MHRA is actively working on.
The current legislation may be relatively light-touch initially, with more detailed guidance developed later and potentially formalised into legislation in the future.
MHRA aims to position the UK as a hub for innovation.
This includes programmes such as the AI Airlock and the IDAP process, which supports accelerated access for innovative devices, particularly in startups.
There are also collaborative initiatives in areas such as oncology to speed up access to promising treatments.
Overall, the aim is to reduce duplication, support international recognition, and simplify market access.
A key challenge is whether approved bodies can scale to meet demand.
Fee increases and designation pressures may limit capacity.
This could create bottlenecks and reduce manufacturer choice, making early engagement with approved bodies important for regulatory planning.
43:10 – Q&A and closing remarks
Questions were raised about classification rule alignment.
There is an intention to align where possible, but differences will remain, particularly in areas such as IVDR and software.
Where MHRA considers regulatory burden disproportionate to risk, divergence from EU rules is likely.
Participants were invited to raise further questions or follow up after the session.
