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European Union

EU Commission Updates Harmonized Standards List for Medical Laboratories’ Accreditation

The Commission of the European Union (EU) has updated the list of harmonized standards used in the process of accrediting laboratories involved in the development or assessment of medical devices.

EU Commission Issues Regulations for Cybersecurity Certification Scheme (EUCC)

The EU Commission has published detailed regulations for the cybersecurity certification of certain products, taking the next step in implementing an EU-wide cybersecurity certification scheme.

U.S. and EU Sign Joint Cybersafe Products Action Plan

The U.S. and the European Union have signed an agreement to work collaboratively to strengthen the cybersecurity of IoT-capable hardware and software products used by consumers.

EU Commission Proposes More Time for Compliance with IVDR

The Commission of the European Union (EU) has proposed providing manufacturers of certain medical...

EU Commission Proposes “One Substance, One Assessment” Strategy for Chemical Assessments

The Commission of the European Union (EU) has recently adopted three separate legislative proposals...
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EU Moves One-Step Closer Toward Regulation of AI

The goal line is in sight for legislators in the European Union (EU) in...

MedTech Europe Offers Its Vision for the Future of MedTech Regulations

A consortium of medical technology companies in the European Union (EU) has published a...

EU Commission Extends Effective Date of Expanded Radio Equipment Requirements

The Commission of the European Union (EU) has extended the effective date of its...

EU Commission Designates Six “Gatekeepers” Under Its Digital Markets Act

The Commission of the European Union (EU) has named six major digital platform companies...

EU Commission Updates Energy Labeling Requirements for Smartphones/Tablets

The Commission of the European Union (EU) has supplemented its energy labeling requirements to...
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