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# EU Seeks Harmonized Medical Device Standards with U.S.
- URL: https://www.fdaweb.com/eu-seeks-harmonized-medical-device-standards-with-u-s/
- Published: 2016-07-18T12:00:00.000Z
- Updated: 2026-09-14T21:15:01.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5136207

The European Union (EU) has proposed to include a medical device annex as part of ongoing negotiations under the Transatlantic Trade Investment Partnership between the U.S and the EU. The annex would encourage more harmonization on regulatory standards between CDRH and its EU counterpart. According to an [EU proposal](http://trade.ec.europa.eu/doclib/docs/2016/july/tradoc%5F154797.pdf?ref=fdaweb.com), such an annex would:

- promote convergence of technical and clinical requirements applicable to medical devices;
- remove unnecessary duplications of data submission and devices testing and to avoid duplications of inspections of manufacturing sites;
- promote convergence of standards relevant to medical devices; and
- promote existing multilateral and bilateral regulatory cooperation relating to medical devices

The EU device proposal calls on each party to actively participate in developing device scientific or technical guidelines under the International Medical Devices Regulators Forum. It also looks to both parties working at establishing a harmonized unique device identification system for medical device surveillance. Additionally, it seeks a standardized format for electronically submitting information and data for new product reviews. And the EU’s proposal seeks an agreement to exchange relevant post-market safety information on non-compliant devices and recalls primarily through the use of the National Competent Authority Report Exchange Program system developed and operated by the International Medical Devices Regulators Forum.

The proposal has been tabled and ongoing discussions are expected. Both sides will continue to talk regularly during the summer and EU ministerial discussions are planned in September.