Important Update on Medical Device Regulation in the UK

The UK government has outlined a roadmap for a new regulatory framework that prioritizes patient safety and ensures access to safe and innovative medical devices. Here are the key dates to keep in mind:

📌 2024

Implementation of priority Post-Market Surveillance (PMS) measures.

📌 Summer 2025

Entry into force of the new PMS requirements.

📌 30 June 2028

Deadline for CE-marked devices under the EU MDD/AIMDD Directives.

📌 30 June 2030

Deadline for CE-marked devices under the EU MDR/IVDR Regulations.

📌 First Half of 2024 – January 2025

Consultations on pre-market regulations, including cybersecurity, Unique Device Identifiers (UDI), and stricter requirements for implantable devices.

🔍 These updates aim to harmonize international practices and ensure a smooth transition for the MedTech industry.

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