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Unofficial consolidated textConsolidated 2026-01-01English

Article 48

Reproduced from official EUR-Lex 1/1/2026.

Official catalogue · non-binding

Related guidance (7)

Current English catalogue entries that refer to Article 48. Guidance is non-binding and kept separate from the regulation text.

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MDCG 2022-12Guidance on harmonised administrative practices and alternative technical solutions until Eudamed is fully functional (for Regulation (EU) 2017/746 on in vitro diagnostic medical devices)July 2022
MDCG 2025-9Guidance on Breakthrough Devices (BtX) under Regulations 2017/745 & 2017/746Note: Pilot to roll-out the guidance is expected to be launched in Q2 2026December 2025
MDCG 2019-6 rev.5Questions and answers: Requirements relating to notified bodiesFebruary 2025
MDCG 2021-23Guidance for notified bodies, distributors and importers on certification activities in accordance with Article 16(4) of Regulation (EU) 2017/745 and Regulation (EU) 2017/746August 2021
MDCG 2020-14Guidance for notified bodies on the use of MDSAP audit reports in the context of surveillance audits carried out under the Medical Devices Regulation (MDR)/In Vitro Diagnostic medical devices Regulation (IVDR)August 2020
MDCG 2019-13 rev.1Guidance on sampling of devices for the assessment of the technical documentationDecember 2024
MDCG 2018-8Guidance on content of the certificates, voluntary certificate transfersNovember 2018

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