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WTO notification · TBT

European UnionProposed measure, may since have been adopted

Live plants, medicines and vaccines, medical devices

Official title

Commission proposal for a Regulation of the European Parliament and of the Council amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards simplifying and reducing the burden of the rules on medical devices and in vitro diagnostic medical devices, and amending Regulation (EU) 2022/123 as regards the support of the European Medicines Agency for the expert panels on medical devices and Regulation (EU) 2024/1689 as regards the list of Union harmonisation legislation referred to in its Annex

The European Union notified this proposed TBT measure to the WTO on 16 January 2026. The comment period closed on 16 April 2026.

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Source: WTO ePing (opens in a new tab). Summaries by Expodite, which is independent of the WTO.

Published here:

At a glance

Products

Medical devices and in vitro diagnostic medical devices

Notifying member
European Union
Status
Proposed measure, may since have been adoptedNotified as a draft on 16 January 2026. Check WTO ePing or the European Union for its current status.
Objectives
  • Protection of human health or safety
  • Harmonization
  • Cost saving and productivity enhancement
Area
TBT: Technical product rulesTechnical barriers to trade
Notification type
Regular notification
Document symbol
G/TBT/N/EU/1184

Key dates

Distributed by the WTO
Comment deadline
Closed on 16 April 2026
Proposed adoption
2026
Proposed entry into force
20 days after its publication in the Official Journal of the European Union

How to comment

The comment period closed on 16 April 2026. You can still raise concerns about the measure with your country's WTO TBT enquiry point, quoting the document symbol G/TBT/N/EU/1184; it can take them up with the European Union.

Find your country's enquiry point on WTO ePing (opens in a new tab)

What the notification says

Regulation (EU) 2017/745 on medical devices (MD Regulation) and Regulation (EU) 2017/746 on in vitro diagnostics medical devices (IVD Regulation) establish a new regulatory framework for medical devices and in vitro diagnostic medical devices. Their objectives are a high level of protection of health for patients and users and the smooth functioning of the internal market for these products. The MD Regulation has been applicable since 26 May 2021. It was notified to the WTO as notification G/TBT/N/EU/71. In March 2023, the European Parliament and the Council adopted a staggered extension of its transition period, ranging from 31 December 2027 for high risk devices to 31 December 2028 for medium and lower risk devices. It was notified to the WTO as notification G/TBT/N/EU/943. The IVD Regulation has been applicable since 26 May 2022. It was notified to the WTO as notification G/TBT/N/EU/72. In January 2022 and in July 2024, the European Parliament and the Council adopted a staggered extension of its transition periods, ranging from 31 December 2027 for high risk in vitro diagnostics to 31 December 2029 for lower risk in vitro diagnostics. They were notified to the WTO as notification G/TBT/N/EU/845 and G/TBT/N/EU/1044. Despite considerable progress made over the past years, multiple challenges regarding the implementation of the Regulations on medical devices and in vitro diagnostics, persist. The notified proposal is the immediate follow up of the targeted evaluation of the…

Sources

Expodite writes its summary from the official record. The notification and the documents it notifies are on the WTO's own websites.

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