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Medical Devices › New Guidance › European Union

Hogan Lovells

MDCG published new guidance on the interplay between the MDR & IVDR and the AI Act

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On 19 June 2025, the Medical Device Coordination Group (“MDCG”) published new guidance on the interplay between the MDR & IVDR and the AI Act (MDCG 2025-6). The document provides a first set of answers to the most frequently...more

Hogan Lovells

New MDCG guidance clarifies rules for medical device software available on online platforms

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The Medical Device Coordination Group (“MDCG”) has issued guidance on the safe making available of medical device software (“MDSW”) apps on online platforms (MDCG 2025-4). MDCG 2025-4 outlines the regulatory roles of online...more

Hogan Lovells

Draft text of new Spanish regulation on medical devices is opened for contributions

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The Spanish Ministry of Health has initiated the hearing and public information process for the new regulation on medical devices. The draft text will be available for contributions by 10 July 2021. The direct application of...more

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The European Commission proposes a new Pharmaceutical Strategy for the EU

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On 25 November 2020, the European Commission published a proposal for a new Pharmaceutical Strategy for Europe (“the Strategy”). The Strategy is built around four main objectives, each with an assigned work strand....more

Hogan Lovells

The European Commission has published guidance on the vigilance system for insulin infusion pumps

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On 6 October 2020, the European Commission published guidance on the vigilance system for insulin infusion pumps and integrated meter systems. The guidance provides an illustrative table with examples of what must be reported...more

Hogan Lovells

European Commission publishes factsheet on the (in vitro) medical devices procurement ecosystem

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The European Commission has published a factsheet addressed to organisers of public tenders involving medical devices. The goal of the factsheet is to provide hospitals, clinics, ministries and competent authorities...more

Hogan Lovells

European Commission publishes factsheet on medical devices and in vitro medical devices for non-EU and non-EEA competent...

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Introduction The European Commission has published a factsheet addressed to competent authorities of third countries....more

Hogan Lovells

The European Commission publishes nine new guidance documents in relation to the MDR and IVDR

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On 20 November 2018, the European Commission published nine new documents intended to provide guidance to non-EU authorities and economic operators in relation to the Medical Devices Regulation (“MDR”) and In vitro Diagnostic...more

Hogan Lovells

New “rolling plan” and new guidance documents in relation to the MDR and IVDR

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The European Commission just published an “implementing measures rolling plan” in relation to the MDR and IVDR which are scheduled to apply from 26 May 2020 and 26 May 2022 respectively....more

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