Implementing Regulation (EU) 2026/977: Notified Body Requirements
10 May 2026
EUDAMED Now Mandatory: Update on National Requirements and Resources
28 May 2026The MHRA published a draft of their proposed regulatory changes: HERE
The draft proposes, but does not yet finalize, a number of changes, including updated classification rules, UDI requirements, implant cards, and new international reliance-based routes for devices approved in certain markets.
Industry is invited to provide feedback until Friday 19 June 2026 (UK time).
Proposed Changes to UKCA Marking
Technical Documentation Changes
Below is an overview of some of the proposed changes:
- Updates references to the IVD Directive 98/79, MD Directive 93/42, and AIMD Directive 90/385 to the EU MDR and IVDR, e.g., ‘Annex I of Directive 93/42’ is replaced with ‘Annex I of Regulation (EU) 2017/745’.
- Introduces a definition for clinical evaluation, which is a “structured, planned and method driven process carried out on a continuous basis to generate, collect, analyse, and assess clinical data related to a device, to verify its safety, performance, and clinical benefits when used as intended by the manufacturer”.
- Introduces definition for intended purpose
- Requires implant cards for implantable devices.
- Updates requirements for custom-made devices (CMDs), including requiring UK Approved Body involvement for Class IIb and III implantable CMDs.
Classification
Medical Devices
These mostly, although do not completely, now align to the EU MDR 2017/745. An example of a difference is EU MDR Rule 3 versus UK MDR Rule 3. In Europe, Class III covers any in vitro contact with human cells/tissues/organs ex vivo, not just embryos. The UK draft limits it to embryos only.
Notably absent? The following EU MDR rules are not included in the UK draft:
- Rule 11 for stand-alone software (SaMD). The draft UK regulation does not create a specific rule for SaMDs; instead, they are classified based on the other available rules for active devices, e.g., active devices intended for diagnosis and monitoring under Rule 10.
- Rule 22 for integrated diagnostic-therapeutic devices, such as closed loop systems or automated external defibrillators.
IVDs
The classification system is completely overhauled, introducing a rule-based classification system (Class A, B, C, and D).
The rules are generally aligned with the EU IVDR 2017/746, although there are some differences, such as:
- UK draft places products for screening/detecting/diagnosing neurodegenerative disease; screening/detecting/diagnosing cardiovascular diseases into Class C (as opposed to Class B under the EU IVDR).
- UK draft does not require an equivalent to EU reference laboratories for Class D devices.
UDI
These requirements generally align with the MDR/IVDR:
- Requirement to assign a Basic UDI-DI
- UDI-DI must be assigned to each device
- The UDI carrier must be included on the device labeling (on the device, or the label, and on all higher levels of its packaging)*
- UDI must be assigned by an MHRA authorized UDI issuing agency
*If the device is intended to be used in a home environment, or by a person other than a healthcare professional, the human readable interpretation (HRI) format must take priority over other information on the device and its packaging.
IVD Conformity Assessment Requirements
The introduction of a risk-based classification system (Class A-D) also changes the conformity assessment requirements for IVDs.
Below are the proposed requirements, as compared to CE Marking under the EU IVDR:
| IVD Class | Sterile? | UK Draft | EU IVDR |
|---|---|---|---|
| Class A | Non-sterile | Self-declaration | Self-declaration |
| Class A | Sterile | Self-declaration | Notified Body involvement required for sterility aspects |
| Class B | Non-sterile | Self-declaration + ISO 13485 QMS certification | Notified Body involvement required |
| Class B | Sterile | Self-declaration + ISO 13485 QMS certification + approved body assessment of sterility aspects | Notified Body involvement required |
| Class C | — | Approved Body involvement required | Notified Body involvement required |
| Class D | — | Approved Body involvement required + batch verification testing | Notified Body + EU reference laboratory involvement required |
Pre-Determined Change Control Plan (PCCP) for Software
The MHRA is introducing a voluntary ‘pre-determined change control plan’ (PCCP) for software devices. The PCCP is developed and submitted as part of the initial conformity assessment process, before the device is placed on the market.
This mechanism allows manufacturers to outline potential modifications to the software and how those will be assessed. If the PCCP is approved by the UK approved body (UKAB), it avoids the typical case-by-case discussion with the UKAB over whether a particular change constitutes a significant change and if it warrants reassessment.
Essentially, under the PCCP model, changes within the agreed scope can proceed without returning to the UKAB each time. This is particularly relevant for AI/ML-based devices, where models may be updated or retrained regularly.
Electronic Instructions for Use (eIFU)
The draft regulation introduces a new section on eIFUs. However, the scope of devices is limited to professional use:
- Active implantable medical devices
- Implantable devices
- Fixed installed medical devices
- Other devices that have a built-in system to visually display the instructions for use
- Software
It does not, as Regulation (EU) 2025/1234 did, extend eIFU requirements to all professional use devices.
Like in the EU, the UK draft does require manufacturers to perform a documented risk assessment, clearly identify that the instructions are being provided in electronic form instead of in paper form, how to access them, and, upon request, provide a free copy of the paper instructions.
Registration
The registration requirement still stands, including that the UK Responsible Person (UKRP) is responsible for entering the device data (unlike with EUDAMED and swissdamed).
However, some additional requirements are proposed, including:
- Identifying if the device contains an Artificial Intelligence component or element
- The name and address of the original device manufacturer, if different from the manufacturer
- Requiring entry of the Basic UDI-DI and UDI-DI data (currently voluntary)
- Periodically verify the correctness of the data relevant to the devices
The draft regulation notes that the manufacturer, UKRP, and device details will be made public, except for “commercially sensitive information or information which, if disclosed, would contravene data protection legislation”.
UK Responsible Person (UKRP)
There is no significant change to UK Responsible Person (UKRP) role and the MHRA kept the requirement for a sole UKRP to represent all of a manufacturer’s devices. This is different from the EU and Swiss Authorized Representative (AR) roles, which only requires that the AR represent all the devices within a single generic device group.
EU vs UK Gaps
The draft UK regulation does not introduce certain EU MDR requirements, for example:
- Appointment of a Person Responsible for Regulatory Compliance (referred to as a Qualified Person in an early version of UK draft legislation).
- Specific requirements for Importers or Distributors
- Expert panels / clinical evaluation consultation procedure
- Annex XVI requirements for devices without a medical purpose, e.g., aesthetic dermal fillers, liposuction equipment
This is not to say that the above may not be introduced in the future. However, they are not included in this proposed legislative change.
New International Reliance Framework
This pathway allows devices with marketing approval from “trusted regulators”, to undergo an abridged review process in Great Britain.
Note that this process is only eligible in Great Britain (England, Scotland, Wales). Northern Ireland, the fourth UK country, requires CE Marking.
Eligible Devices
There are three “routes” available, and the criteria are based on the UK classification of the device. Therefore, manufacturers must first classify their device to UK rules in order to understand their eligibility.
Route 1: Eligibility for International Reliance
| Device category (UK classification) | Eligible foreign approval pathway |
|---|---|
| Class I (non-sterile, non-measuring, non-software) | Any applicable medical devices legislation in Australia, Canada, or the US |
| Class A IVD (non-sterile) | Any applicable medical devices legislation in Australia, Canada, or the US |
Route 2: Eligibility for Certificate of International Reliance
| Device category (UK classification) | US | Australia | Canada |
|---|---|---|---|
| Class I sterile and/or measuring | 510(k) or De Novo | Therapeutic Goods Regulations | — |
| Class IIa | 510(k), De Novo, or PMA | Therapeutic Goods Regulations | Class III or IV under Canadian MDR |
| Class IIb | 510(k), De Novo, or PMA | Therapeutic Goods Regulations | Class III or IV under Canadian MDR |
| Class III | PMA only | Therapeutic Goods Regulations | Class IV under Canadian MDR |
| Class A IVD (sterile only) | 510(k) or De Novo | Therapeutic Goods Regulations | — |
| Class B IVD | 510(k), De Novo, or PMA | Therapeutic Goods Regulations | Class III or IV under Canadian MDR |
| Class C IVD | 510(k), De Novo, or PMA | Therapeutic Goods Regulations | Class III or IV under Canadian MDR |
Route 3: Eligibility for Certificate of International Reliance
| Device category (UK classification) | US | Australia | Canada |
|---|---|---|---|
| Class IIa, IIb, or III (non-software, no ancillary medicinal substance) | 510(k) only | — | — |
| Class IIb or III incorporating an ancillary medicinal substance | 510(k), De Novo, or PMA | Therapeutic Goods Regulations | Class IV under Canadian MDR |
| Class D IVD | 510(k), De Novo, or PMA | Therapeutic Goods Regulations | Class III or IV under Canadian MDR |
| Class I measuring, Class IIa, IIb, or III – software | 510(k), De Novo, or PMA | Therapeutic Goods Regulations | Class III or IV under Canadian MDR |
Exclusions
The following are excluded from all routes:
- Devices certified for inclusion in the Australian Register of Therapeutic Goods, e.g., a device that leveraged its Japan or Singapore marketing authorization in order to register in Australia, is not eligible for UK international reliance certification
- Devices containing non-viable cells or tissues of human origin
- Devices manufactured utilizing animal tissue or derivatives (except IVDs)
- Devices co-packaged with a medicinal product
- Companion diagnostics
Documentation Requirements
The UK draft regulation proposes that eligible international reliance devices are exempt from the following parts of the UK MDR 2002:
- Regulation 8: essential requirements / GSPRs
- Regulation 8A: technical documentation requirements (CER, RMF, full tech file)
- Regulation 9: determining compliance with essential requirements
- Regulation 13: UKCA marking procedures
- Regulation 17/18: manufacturer and approved body conformity assessment procedures
- Regulation 22/22A: AIMD essential requirements and technical documentation
- Regulation 34: IVD essential requirements
- The clinical investigation regulations
- The full conformity assessment procedural framework
Below are the documentation requirements per route.
Route 1: documentation requirements
- Declaration that the device complies with an appropriate quality management system (such as ISO 13485)
- Labelling compliant with the comparable regulator country’s requirements (in English), plus any additional UK-specific labelling requirements
- Name and address of the UK Responsible Person (if applicable) included on the product labelling, outer packaging, or IFU
- If the device contains any substances that are known allergens or sensitizers, these must be identified on the labelling
- If the device has a measuring function, measurements must be expressed in units conforming to the UK Units of Measurement Regulations 1986
- Post-market surveillance system (including vigilance), plan, and periodic reporting in compliance with UK PMS requirements
- UDI compliant with the comparable regulator country’s requirements, if UDI is required by that regulator for the device; otherwise, manufacturer must assign UDI compliant with UK requirements before placing the device on the market in Great Britain
At face value, per the draft text, some Route 1 eligible devices have a significantly lighter path to market than UKCA Marking. For example, a manufacturer of a Class I FDA 510(k) exempt device will have less documentation requirements than one who markets via UKCA Marking, which would necessitate creation of a full technical documentation file, including a clinical evaluation.
Route 2: UKAB application documentation requirements
- Name and address of the manufacturer
- Description of the device
- Intended purpose of the device
- Name of the comparable regulator country where the device has been authorised, evidence of that authorization, and a statement that use of the device is not suspended in that country
- Classification of the device under UK regulations and an accompanying rationale
- Statement of which Route applies and an accompanying rationale
- Evidence of a certified quality management system:
- Australia: conformity assessment certificate issued by the TGA
- Canada: MDSAP certificate
- USA: MDSAP certificate or ISO 13485 certificate from an IAF-accredited certification body
- Labelling compliant with the comparable regulator country’s requirements (in English), plus any additional UK-specific labelling requirements
- Instructions for Use (where applicable)
- UDI-DI for the device
- Implant card and patient information leaflet (where applicable)
- List of part numbers
- Explanation of what other UK product safety or health and safety legislation applies to the device
- Information demonstrating compliance with measuring function requirements (where applicable)
- Post-market surveillance plan
- Post-market surveillance data covering the most recent period the device has been available inside and outside GB, up to five years (including any ongoing field safety corrective actions and information on any significant increase in frequency or severity of incidents)
- Information stating whether the device has marketing authorization in more than one comparable regulator country
- Evidence of the agreement between the manufacturer and the UK Responsible Person (where applicable)
- For devices connected to or equipped with an energy source: technical reports demonstrating the device is designed and manufactured to reduce electromagnetic interference risks as far as possible
- For devices connected to or equipped with an energy source: technical reports demonstrating adequate intrinsic immunity to electromagnetic interference
Route 3: All documentation in Route 2, plus the following
- For devices subject to US 510(k): the predicate equivalence rationale that was submitted during the 510(k) process in the USA
- For devices incorporating an ancillary medicinal substance: information regarding the usefulness of incorporating that substance into the device
- For Class D IVDs:
- Results of batch verification tests demonstrating the device meets the performance characteristics set by the manufacturer and, where applicable, common specifications
- A plan for regular independent batch verification testing to ensure the device continues to meet those performance characteristics on an ongoing basis
- For software devices: a comparison of any differences between the intended population, user and use environment in the comparable regulator country and GB, plus information demonstrating those differences will not adversely impact safety or performance
- Where applicable: a Predetermined Change Control Plan (PCCP) complying with the PCCP requirements in the draft regulation
Conformity Assessment Process
Route 1 devices do not require conformity assessment via a UK Approved Body (UKAB). Instead, those manufacturers ‘self-certify’ compliance with the International Reliance pathway.
For all Route 2 and Route 3 devices, the UKAB must confirm:
- The device has been authorised for use in the relevant comparable regulator country
- The device has been correctly classified under UK regulations
- The post-market surveillance plan meets UK PMS requirements
- Available post-market information does not show any emerging serious risks
- Where applicable, the implant card and patient leaflet meet UK requirements
- Where applicable, instructions for use for reusable devices include adequate information on cleaning, disinfection, packaging, sterilization method, and any restriction on number of reuses
For Route 3 devices only, the UKAB must additionally confirm:
- For 510(k) devices: the predicate equivalence rationale meets UK equivalence requirements (Regulations 9A or 23A)
- For devices with an ancillary medicinal substance: the UKAB must request an opinion from the Secretary of State on the quality and safety of the substance, including its clinical benefit and risk profile — the Secretary of State must provide that opinion before the certificate can be issued
- For software devices: where a PCCP has been submitted, it has been accepted in the comparable regulator country
If the UKAB identifies a serious risk or serious safety concern when reviewing the post-market surveillance data, it must request further information from the manufacturer demonstrating that the risk has been addressed before proceeding.
Certificate of International Reliance: validity and expiry
The certificate expires on different dates depending on the comparable regulator country.
| Comparable regulator country | Certificate expires | To maintain validity before expiry, provide |
|---|---|---|
| Australia | Expiration date of the TGA conformity assessment certificate | New TGA conformity assessment certificate |
| Canada | Expiration date of the MDSAP certificate | New MDSAP certificate |
| USA | Expiration date of the MDSAP or ISO 13485 certificate | New MDSAP certificate, or new ISO 13485 certificate from an IAF-accredited body |
Where a renewed underlying certificate is provided before the expiry date, the UKAB amends the expiration date on the Certificate of International Reliance accordingly.
The certificate ceases to apply if:
- The authorization in the comparable regulator country is suspended or cancelled
- The manufacturer withdraws the device from use in the comparable regulator country
UK Responsible Person & Registration
Manufacturers must appoint a UK Responsible Person (UKRP) and include the UKRP’s information on their labeling. Further, the UKRP must register the device with the MHRA before it can be legally marketed.
Impact on CE Marked Devices
Currently, there is no change in how the MHRA treats CE Marked devices. As part of the Brexit transition, and to prevent disruption to UK healthcare, the MHRA accepts CE Marked devices.
Note: manufacturers must additionally appoint a UK Responsible Person (if applicable), register with the MHRA, and conform to the UK’s post-market surveillance and vigilance requirements.
The MHRA is currently evaluating if they will continue to recognize CE Marking indefinitely. The public consultation for this expired on 10 April 2026, and now industry is waiting for the MHRA’s response to the consultation.
Timing
Interested parties have until 19 June 2026 to provide comments.
The MHRA will review the feedback, once available, and draft a final version of the legislation. It will then be laid in Parliament as a Statutory Instrument (allowing faster processing). Once approved by Parliament, it will be formally published and then should come into force six (6) months later.
Further, the regulation itself will include transitional provisions, to allow manufacturers with currently UKCA marked devices time to comply with the new requirements.
