Quality & complianceOfficial

INFARMED reminds manufacturers EUDAMED device registration transition ends 28 November 2026

🇵🇹 INFARMED · Thu 12 Nov 2026

Portugal's medicines and health products authority says registration of devices placed on the market before 28 May 2026 must be finished by 28 November, with a notified body deadline following in 2027.

INFARMED, the Portuguese regulator, has reminded manufacturers, and producers of systems and procedure packs, that the legally set transitional period for registering devices in the European database on medical devices (EUDAMED) ends on 28 November 2026.

The deadline applies to devices that were placed on the market before 28 May 2026. According to the authority, meeting it is essential to maintain regulatory compliance and to ensure devices can continue to be made available on the market.

INFARMED sets out two dates. The first, 28 November 2026, marks the end of the transitional period for manufacturers and producers to register devices, systems and procedure packs. The second, 28 May 2027, is the final date by which notified bodies must register certificates they issued before 28 May 2026.

The agency also encourages operators to submit their data to the platform early, to avoid problems as the deadline approaches. The notice, dated 12 November 2026, gives no further detail on the registration process.

What it means for your team

  • Manufacturers and system or procedure pack producers should confirm that registrations for all devices placed on the market before 28 May 2026 are complete before 28 November 2026.
  • Regulatory teams should check their internal EUDAMED data-entry plans and avoid leaving submissions to the final days.
  • Companies relying on notified body certificates should note that bodies have until 28 May 2027 to register certificates issued before 28 May 2026.

Official source: INFARMED ↗

Article written by VigiEye from the official source (INFARMED). AI-assisted; check the source before acting.

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