EUDAMED Mandatory Use: Insights and Timeline from the June 26, 2025 MDCG Working Group Meeting
14 July 2025
July “In All Other News”: MDR/IVDR Reform, UK to Align with EU IVD Common Specifications, Team-NB MDR Training, and more
5 August 2025Background
In November 2024, the MHRA opened a consultation on the following topics:
- Allow certain devices with marketing authorization in Australia, Canada, Europe, and the US, to have an abridged review process in the UK.
- Primarily devices that have been through an equivalent, or near equivalent, regulatory review process as required in the UK. For example, devices that have an FDA 510(k) clearance, but which are Class IIb implantable or Class III in Great Britain, are not eligible.
- Introduce Unique Device Identification (UDI) requirements.
- And as a result, propose that manufacturers of UKCA marked devices can stop adding the UKCA marking symbol to their devices.
- Reclassify IVDs into a risk-based rules structure.
- As well, introduce a more risk-proportionate process for Class B IVDs, which would allow them to be “self-certified”. However, QMS certification would be required.
The consultation closed in January 2025.
Overview of MHRA Updates
The MHRA’s response to the above consultation feedback is available: HERE
International Reliance (and Possible Indefinite Recognition of CE Marking)
The MHRA proposed four different access routes for international reliance (see table below).
Stakeholder feedback was generally positive and in support of an international reliance program. However, some of the comments noted:
- There should be transparency regarding costs and timelines with this route.
- The scope should be expanded to include software as a medical device and implantable devices via 510(k) route.
- Suggested that the UK Approved Body review of EU CE marked devices (Route 2) might be “repetitious and lead to unnecessary costs and delays compared to the current transitional arrangements for CE marked medical devices”. And suggested continued recognition of CE marked devices beyond 2030.
The MHRA responded:
- They will proceed with implementing the proposed international reliance routes 1, 3, and 4.
- They will consider indefinitely extending the recognition of CE marked devices in accordance with the current transitional arrangements, instead of proceeding with Route 2.
- Route 4 will be expanded to include software as a medical device and implantable Class IIb and Class III devices that comply with 510(k) legislation in the US, subject to the demonstration of entire equivalence.
- Clarifying that device classifications will be in accordance with UK MDR 2002 classification rules.
They also confirmed that devices without an intended medical purpose are not currently in the scope of the UK MDR 2002, and therefore not eligible for international reliance. Instead, they are subject to other legislation as applicable, e.g., the EMC regulation.
| Route | Eligible Devices | Approved Body Review Required |
| Route 1 | – Class I MDs (excluding Is/Im) – Class A IVDs (non-sterile) | No approved body review Self-declaration of QMS during registration |
| Route 2 | Non-active devices from EU (MDR/IVDR): – Class Is/Im, IIa, IIb, III MDs – Sterile Class A IVDs – Class B, C, D IVDs | UK Approved Body must: (a) Confirm CRC authorisation (b) Confirm GB classification (c) Confirm GB requirements (d) Review PMS plan (e) Review 5 years PMS data (if available) |
| Route 3 | Non-active devices from Australia, Canada (Class III/IV), USA (De Novo, PMA, 510(k)): – Class Is/Im, IIa, IIb, III MDs – Sterile Class A IVDs – Class B, C IVDs | UK Approved Body must perform Route 2 checks plus: (b) Confirm implant card & leaflet compliance (c) Confirm reuse instructions (if applicable) |
| Route 4 | – Class IIa, IIb (non-implantable) & specific IIb implants (510(k), USA) – MDs with ancillary medicinal substance (Australia, Canada, USA) – Class D IVDs (Australia, Canada, USA) – Active devices (all CRCs) – Software MDs (excluding USA 510(k)) | UK Approved Body must perform Route 3 checks plus: (b) Confirm equivalence rationale (510(k)) (c) Obtain medicinal opinion (if applicable) (d) Confirm Class D batch testing (e) Confirm electrical compliance (f) Review safety & change control (software) |
| Devices not eligible for any route: – software as a medical device that has gained access to the USA market via the FDA 510(k) clearance process – devices that comply with 510(k) legislation in the USA that are classified in GB as Class IIb implantable (excluding the devices listed in Route 4) and Class III – devices granted market access in CRC via reliance routes – devices that contain non-viable cells and tissues of human origin Devices only eligible for Route 2: – medical devices that utilise animal tissues and their derivatives – medicinal products that include a medical device in the secondary packaging of the medicinal product (i.e. co-packaged) -companion diagnostics | ||
Reclassification & Pathway for IVDs
The MHRA proposed to 1) amend the classification system for IVDs, and 2) introduce new conformity assessment routes for IVDs (see table below).
Stakeholder feedback was generally positive on reclassification and the new routes. For example, while only 48% supported amending the conformity assessment routes, 45% had no opinion.
However, feedback was mixed on the proposal to require ISO 13485 for Class B IVDs (see table below). 49% were in support, 44% were not in support, and 7% had no opinion.
The MHRA responded:
- They will amend the conformity assessment routes for IVDs (including IVD software) in line with the original proposal. This includes requiring ISO 13485 certification for Class B UKCA marked IVDs. To increase flexibility, they will:
- Recognize QMS certification issued by International Accreditation Forum (IAF) accredited certification bodies from Comprehensive and Progressive Agreement for Trans-Pacific Partnership (CPTPP) countries as well as QMS certification issued by UKAS accredited bodies.
- Continue to explore the feasibility of recognition MDSAP certification.
- Regarding the concerns around Class B device requirements, the MHRA will engage with key stakeholders during the development of this conformity route, to help address potential issues around having a different process from EU IVDR Class B devices.
- Further, the MHRA reiterated that they will further explore indefinite recognition of CE marked devices.
| Classification | Risk Level | Market Access Route | Specific Requirements |
| Class A* | Low individual risk and low public health risk | UKCA self-declaration of conformity | – Self-declaration against relevant Essential Requirements – Fulfil obligations in IVDD Annex III |
| Class B* (incl. self-test devices not in a critical situation) | Moderate individual risk and/or low public health risk | UKCA self-declaration of conformity + QMS certification | – Self-declaration against Essential Requirements – Fulfil obligations in IVDD Annex III – QMS certification to ISO 13485 (UKAS-accredited) |
| Class C (incl. self-test) | High individual risk and/or moderate public health risk | UKCA conformity assessment by an Approved Body | – Audit of QMS (IVDD Annex IV or MDSAP) – Audit of technical documentation (sample only) |
| Class D | High individual risk and high public health risk | UKCA conformity assessment by an Approved Body | – Design dossier review – QMS audit (Annex IV or MDSAP) – Batch release by approved body – Compliance with common specifications |
| *Note: If a Class A or B IVD is sterile, it must undergo conformity assessment by an approved body for sterility only. | |||
UDI & UKCA Symbol
The MHRA proposed removing the requirement for a UKCA certified device, to be UKCA marked on the device and labeling. This is due to the intent to require manufacturers to assign Unique Device Identification (UDI) to medical devices before they are placed on the Great Britain market.
The majority of stakeholders supported this initiative, and that the combination of the MHRA registration and UDI could be used to verify information. Though some disagreed, stating that the UKCA marking was a “useful quick visual indicator” of conformity.
The MHRA responded:
- They will remove the requirement for UKCA marking on the device, contingent upon manufacturers assigning UDI to the device, and the UDI being searchable in a public-facing database.
- Confirmed that while adding the UKCA marking is no longer mandatory, it is not prohibited either. i.e., it can be voluntarily included.
Note that this is not removing UKCA marking as a valid regulatory route. It only removes the requirement to add the symbol on the device.
Next Steps
The majority of the above changes will be introduced in a new ‘Pre-Market’ legislation, currently under development. The MHRA intends to publish the draft later this year. Per the MHRA’s 2024-2026 roadmap, they aim to introduce the regulation into Parliament in late 2025, with enforcement in 2026.
Removal of the UKCA marking symbol requirement will be published afterward, under separate legislation. It will occur after the MHRA’s updated registration database is operational, and the UDI transitional period has ended.
Further, the MHRA will prepare a new consultation on their approach to CE Marked devices, i.e., to address stakeholder feedback regarding indefinite recognition of CE marking.
