The MHRA's 2026 Draft Regulations: Two Proposed Changes Every Human Factors Practitioner Should Be Responding To

On 8 May 2026, the MHRA published the draft Medical Devices (Amendment) Regulations 2026, the most significant proposed reform to the UK medical device regulatory framework since Brexit. The draft is wide-ranging, covering international reliance, classification, software, cybersecurity, and electronic instructions for use. For a comprehensive overview, the Hogan Lovells briefing published on 13 May is a solid starting point.

This blog does not attempt to cover all of it.

What it does is focus on two specific proposals: mandatory implant cards and mandatory unique device identifiers (UDI). Both are framed as traceability and transparency measures, but at implementation level both are fundamentally about how real people interact with information under pressure. That is an HF problem. The MHRA consultation, which closes on 19 June 2026, is the right moment for the HF community to say so.

The two proposals

1. Implant cards

The draft would require healthcare organizations that implant medical devices to give patients an implant card describing the implanted device. The stated aims are to improve patients' ability to manage adverse events and to increase transparency.

2. Mandatory unique device identifiers (UDI)

The draft would make UDIs compulsory to enable precise identification and traceability across a device’s lifecycle. Manufacturers would place the UDI on the device (or its label) and all higher levels of packaging, submit the Basic UDI-DI and UDI-DI to the MHRA registration system, and reference the UDI in the technical documentation.

Both are sensible policy goals, but neither is straightforward in practice. The gap between regulatory intent and the human reality is where HF practitioners can add the most value.

MHRA vs EU MDR at a glance

The EU has been operating mandatory implant cards under Regulation (EU) 2017/745 Article 18 and mandatory UDI under Article 27 since 2021. The tables below summarise how the MHRA draft compares; the HF deep-dive on each requirement follows in the sections below.

Three implant card aspects do not lend themselves to direct comparison. On accountability, the EU obligates the manufacturer to produce the card to specified format and language requirements, with the healthcare institution completing patient-specific fields; the MHRA draft puts the card in the hands of the implanting organization without making the manufacturer’s design role explicit. On use scenarios, the EU framework recognizes three (device identification, patient self-identification at airport security or MRI, and emergency clinician access); the MHRA draft captures the first and third but not the second, a meaningful gap for patients with pacemakers, cochlear implants, or neurostimulators. On exemptions, the EU lists low-risk implantable items (sutures, staples, screws, plates, dental fillings) that do not require a card; the MHRA draft is silent, creating uncertainty for manufacturers of those device types.

Three UDI aspects also sit outside the table. Both regimes place UDI carriers on the device or its label and on higher-level packaging, with data submitted to a registry (EUDAMED for the EU, the MHRA registration system for the UK). These are structurally aligned, but the parallel registries mean duplicated effort for manufacturers serving both markets. The EU explicitly requires UDI on the implant card under Article 18; the MHRA draft does not link the UDI and implant card requirements, which weakens the patient-facing chain. Both regimes envisage a public-facing UDI search (EUDAMED is live; the MHRA references it as an ambition), but patient lookup should be framed as supplementary. The principal safety-notification channel sits with manufacturers and healthcare facilities. 

Implant cards: the right idea, with a design problem hiding inside it

The case for implant cards is easy to make. Patients with implanted devices need to be able to communicate key device information in emergencies, during follow-up appointments or international travel, or before procedures that could be contraindicated. At the moment, that information often lives only in a hospital record that may not be accessible when it matters most.

But the proposal focuses on what information should be on the card, not on who will use it, under what conditions, or whether they will be able to use it effectively. That is precisely the kind of gap that human factors engineering is designed to close.

The primary user of an implant card is not a clinician. It is a patient, often elderly, anxious, managing multiple conditions, and dealing with the cognitive load that comes with a new diagnosis. Secondary users include carers, paramedics, and clinicians who encounter the patient without access to their records.

Implant cards could contain a great deal of information: device name, manufacturer, model number, UDI, implant date, implanting hospital, implanting clinician, relevant contraindications, emergency contact information, and more. The temptation, when multiple stakeholders are consulted, is to include everything, but a card that contains everything communicates nothing clearly. Patients under stress do not process dense text. Paramedics do not have time to search a card for the one piece of information they need. The information hierarchy must be driven by use scenarios and validated with representative intended users.

Good implant card design requires the same process as any other medical device labelling: user needs analysis, iterative prototyping, formative testing across user groups, and validation. The MHRA's own guidance on applying human factors to medical devices (updated January 2025) makes the point that usability engineering is an iterative process across the product lifecycle. The same standard should apply to implant cards.

Despite the EU's more developed framework, usability problems with implant cards persist across Member States, in part because MDCG 2019-8 does not mandate usability evaluation of card designs.

What does this mean for the HF community

The HF community should be encouraging the MHRA to:

• Define minimum usability standards for implant card design, covering all three use scenarios (patient information access, emergency/MRI/security identification, and clinician decision support)

• Reference IEC 82079 and existing MHRA HF guidance as relevant frameworks

• Clarify responsibility for card design (manufacturer, implanting hospital, or a national template), since this determines who is accountable for usability

• Address digital equivalents: a physical card can be lost or damaged, so a digital alternative may be needed, with its own accessibility requirements

• Explicitly link the implant card to UDI, as EU MDR does, so the card connects to the searchable database

UDI: traceability for the system, complexity for the user

The case for mandatory UDI is strong. Unique device identifiers allow precise tracking through the supply chain, across hospitals, and into post-market surveillance. They enable faster, more targeted recalls. They reduce counterfeit risk and support real-world evidence generation.

But UDI implementation has a human factors dimension that the draft does not address: the UDI appears on device labelling. And labelling is a user interface.

The labelling design challenge

A UDI is not a single number. It consists of a device identifier (DI) and a production identifier (PI). Both may appear on a label as human-readable text and as a machine-readable data carrier (typically a barcode or QR code). On a small device, the label must also carry expiry and lot data, the manufacturer’s name, the CE or UKCA mark, symbols, warnings, and instructions.

The result is a label that is visually complex, cognitively demanding, and difficult to use. The information is technically all there; whether it is accessible in a busy clinical environment, under time pressure, often in poor lighting, is a different question.

When labels contain multiple alphanumeric strings that look superficially similar (lot numbers, serial numbers, reference numbers, UDIs) the risk of misidentification increases. Use errors associated with device labelling are consistently among the most reported categories in adverse event databases on both sides of the Atlantic, and mandatory UDI adds another string to an already crowded space.

This does not mean UDI is a bad idea. It means mandatory UDI should be accompanied by clear human factors guidance on label design: information hierarchy, typographic differentiation between identifier types, appropriate use of ISO 15223 symbols, and testing in realistic use environments. The MHRA's HF guidance already establishes the principle that user interface design must be tested for safety; the same logic must extend to labelling that incorporates UDI.

The patient-facing dimension

The 2026 draft also references UDI in the context of public-facing searchability, the ambition that patients and caregivers should be able to look up their device using its UDI. The role this is intended to play matters. Patient lookup should not be the primary mechanism by which patients learn of safety issues; that responsibility sits with manufacturers and healthcare facilities, whose notification systems are the principal risk control. Patient-facing search is a supplementary capability, useful for transparency, but not a substitute for proactive notification.

A UDI-linked public database is a genuinely patient-empowering idea, similar in spirit to the implant card requirement. But the HF question is broader than the search interface alone. The user interface of a UDI system is the full chain by which patients and clinicians are informed about a device: the manufacturer’s field safety notice processes, the healthcare facility’s patient communication systems, the labelling that lets a patient or carer locate a UDI, and the database itself. Each is a UI that should be considered in development, validation, and post-market review.

Existing notification systems are likely an improvement on what came before, but they are not perfect; the HF contribution is to make sure they are designed, tested, and reviewed as user interfaces in their own right.

For HF professionals, the EU's phased rollout has generated five years of evidence about how UDI implementation plays out at the label design level. Adverse event reports, notified body reviews, and clinical procurement teams document precisely the problems described above: crowded labels, poor typographic differentiation between UDI and other identifiers, and point-of-care confusion. That evidence has not been systematically incorporated into any regulator's label design guidance, the EU's included. The MHRA has the opportunity to do so now.

What does this mean for the HF community?

The HF community should be encouraging the MHRA to:

• Issue specific human factors guidance on UDI label integration: information hierarchy, typographic standards, and use of ISO 15223 symbols alongside UDI data carriers

• Require that labels incorporating mandatory UDI be subject to formative usability evaluation in realistic use environments

• Distinguish between B2B labelling and point-of-care labelling, which may have different design requirements

• Address the patient-facing use of UDI as a distinct design problem: treating the manufacturer’s field safety notice processes, healthcare-facility notification systems, and patient-facing database as a single UI chain to be tested and reviewed in the round

• Explicitly link the UDI requirement to the implant card requirement as EU MDR Article 18 does

Align with existing guidance: FDA UDI labelling and EU MDR Annex I are useful reference points but neither is sufficient for a patient-facing context

Why this consultation matters for the HF community

The MHRA is actively inviting views. The stakeholder impact survey is open until 19 June 2026, and responses from HF practitioners are explicitly welcomed.

The risk of not engaging is real. Both requirements will almost certainly become law in some form. The question is whether the implementation guidance that follows will be informed by human factors thinking, or written primarily by people whose expertise is in regulatory process rather than user behavior.

The 2026 draft gives the HF community an opportunity to shape these requirements before implementation guidance is written, rather than retrofitting it after the fact. That opportunity closes on 19 June.

Key references and links

• MHRA press release: draft Medical Devices (Amendment) Regulations 2026

• MHRA stakeholder impact survey (closes 19 June 2026)

• Draft regulations on the WTO notification portal

• MHRA guidance on applying human factors to medical devices (updated January 2025)

• MHRA implementation of the future regulation of medical devices

• Hogan Lovells briefing on the 2026 draft regulations

How to respond

The MHRA consultation survey is available at: https://www.gov.uk/government/calls-for-evidence/pre-market-medical-devices-regulation-stakeholder-impact-survey