As of January 2025, the UK government has provided updated guidance on the regulatory requirements for in vitro diagnostic medical devices (IVDs) concerning UK Conformity Assessed (UKCA) marking. This guidance outlines the transitional arrangements and timelines for the acceptance of CE-marked IVDs on the Great Britain market, as well as the implementation of future regulations.
Transitional Arrangements for CE-Marked IVDs
To ensure a smooth transition and continuous supply of medical devices, the UK government has extended the acceptance of CE-marked IVDs on the Great Britain market. The key timelines are as follows:
• IVDs Compliant with EU IVDD: In vitro diagnostic medical devices that comply with the EU In Vitro Diagnostic Medical Devices Directive (IVDD) can be placed on the Great Britain market until the sooner of the certificate's expiry or 30 June 2030.
• IVDs Compliant with EU IVDR: Devices that meet the requirements of the EU In Vitro Diagnostic Medical Devices Regulation (IVDR) can be placed on the Great Britain market until 30 June 2030.
These extensions aim to support the ongoing safe supply of medical devices and ease the transition to the future regulatory framework.
The UK government is committed to introducing new regulations for medical devices that prioritize patient safety, ensure access to necessary devices, and maintain the UK's attractiveness for medical technology innovators. The approach to this reform was outlined in the government's response to the 2021 consultation on the future regulation of medical devices in the UK. A proportionate, phased implementation is planned to support system readiness and minimize the risk of supply disruption for UK patients.
Key Points for Manufacturers
• UKCA Marking: While CE marking will be accepted during the transitional period, manufacturers are encouraged to prepare for UKCA marking requirements for placing IVDs on the Great Britain market in the future.
• Registration with MHRA: All medical devices, including IVDs, must be registered with the Medicines and Healthcare products Regulatory Agency (MHRA) before being placed on the Great Britain market.
• UK Responsible Person: Manufacturers based outside the UK must appoint a UK Responsible Person to act on their behalf in carrying out specified tasks, such as device registration.
The UK’s current UKCA system still follows IVDD-based rules under the Medical Devices Regulations 2002 (UK MDR 2002), meaning that:
IVD classification remains unchanged (no switch to the IVDR model yet).
Self-certification for low-risk devices is still allowed.
Notified Body involvement remains required only for high-risk IVDs.
UKCA currently allows more self-certification than IVDR.
UK-Approved Bodies (UKABs) must conduct conformity assessments for higher-risk devices (similar to IVDD’s Notified Body process).
Currently, UK MDR 2002 does not enforce IVDR-style performance evaluation.
Current UKCA requirements do not include post-market surveillance reports, periodic safety update reports, or post-market performance follow-up.
UKCA requires manufacturers outside the UK to appoint a UK Responsible Person (similar to the EU’s Authorised Representative).
Importers and distributors must ensure device compliance before placing products on the UK market.
Unique device identification is not currently required under UKCA rules, but future UK reforms may introduce similar tracking measures.
However, the MHRA plans to implement a new UK regulation similar to IVDR, with phased changes expected over the next few years.
The UK has a shortage of UKABs compared to EU Notified Bodies, which may create bottlenecks once stricter UK regulations align with IVDR.
Once the UK introduces its new regulatory framework, performance evaluation requirements will likely become more stringent.
The MHRA intends to introduce stricter post-market surveillance obligations similar to IVDR in the future.
CE-marked IVDs can still be sold in Great Britain until June 30, 2030, with the UKCA marking requirement is delayed to allow manufacturers more time. New UK medical device regulations (expected in 2025–2026) may introduce IVDR-like requirements, but details are still evolving.
How Should IVD Manufacturers Prepare?
For the EU Market: Compliance with IVDR is mandatory—most IVDs now require Notified Body approval, clinical evidence, and UDI implementation.
For the UK Market:
CE-marked IVDs are still accepted until 2030.
UKCA currently follows IVDD rules, but future regulations may align more closely with IVDR.
Manufacturers should prepare for stricter UK requirements in the coming years (e.g., performance evaluation, PMS, UDI).
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