Your CE mark will not protect your UK market access indefinitely

Post-Brexit, medical devices sold in Great Britain require UKCA marking rather than CE marking. The MHRA has extended transition periods multiple times, creating uncertainty, but the direction of travel is clear. Companies that delay UKCA transition risk being unable to sell in the UK market and face a compressed timeline that increases cost and risk.

• The primary root causes include the ongoing uncertainty and frequent extensions of UKCA marking deadlines by the MHRA, which disincentivises early action.
• This leads to a reactive rather than proactive approach.
• Additionally, resource constraints within MedTech companies, particularly SMEs, and a lack of clear, consolidated guidance on the transition process contribute to delays and confusion.

No verified UK data available for the specific cost range of £40,000-£120,000 per Class IIb device for UKCA marking, though significant costs are associated with the process (MHRA, 2024)

• Delayed product launches and market access in Great Britain
• Diversion of internal resources from innovation to regulatory compliance
• Loss of revenue from inability to sell non-compliant devices
• Increased costs due to expedited regulatory services or consultants
• Delayed access to innovative medical devices for UK patients
• Reduced choice of medical devices for healthcare providers
• Damage to brand reputation due to non-compliance or product withdrawal
• Loss of trust from healthcare providers and patients

What it looks like in practice

• Backlogs at UK Approved Bodies leading to longer certification times
• Increased internal resource strain due to rushed compliance efforts
• Loss of market share or inability to launch new products in Great Britain
• Penalties or enforcement actions from the MHRA for non-compliance