Source

EUR-Lex Official Journal

Regulation Category Type · Breadth Date

Commission Implementing Regulation (EU) 2026/977 laying down uniform quality management and procedural requirements for notified body conformity assessment activities under MDR and IVDR

Implementing regulation establishing uniform quality management and procedural requirements for notified bodies conducting conformity assessment under MDR and IVDR.

EUR-Lex Official Journal · EU-wide

Medical Devices & IVD Notified bodies CE marking Medical devices

Rule change Framework May 04, 2026

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Commission Implementing Regulation (EU) 2026/771 establishing the European Health Data Space Board

Implementing regulation establishing the governance structure and operational procedures for the European Health Data Space Board.

EUR-Lex Official Journal · EU-wide

Health Data, Privacy & SecurityDigital Health & AI EHDS Health data Interoperability

Rule change Framework Apr 07, 2026

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Commission Delegated Regulation (EU) 2026/1451 amending MDR as regards exemptions from clinical investigation for implantable and Class III devices

Amendment to MDR exemption list for implantable and Class III devices from clinical investigation obligations.

EUR-Lex Official Journal · EU-wide

Medical Devices & IVD Medical devices Clinical evaluation CE marking

Rule change Framework Mar 20, 2026

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Commission Implementing Decision (EU) 2026/901 on European standards for products under Regulation (EU) 2023/988, repealing Decision (EU) 2019/1698

Implementing decision establishing European standards for products under the medical devices framework, repealing the prior 2019 decision.

EUR-Lex Official Journal · EU-wide

Medical Devices & IVDGeneral Regulatory Medical devices

Rule change Framework Apr 17, 2026

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Commission Delegated Regulation (EU) 2026/1359 amending MDR as regards class IIb implantable devices exempted from technical documentation assessment

Amendment to MDR establishing exemptions from technical documentation assessment for specified class IIb implantable devices.

EUR-Lex Official Journal · EU-wide

Medical Devices & IVD Medical devices Device classification CE marking

Rule change Product class Mar 20, 2026

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Showing 5 of 5 tracked updates — health-tech relevant only. Show all health policy