EUR-Lex Official Journal · March 20, 2026

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

Original title: Commission Delegated Regulation (EU) 2026/1451 of 20 March 2026 amending Regulation (EU) 2017/745 of the European Parliament and of the Council as regards the list of implantable devices and class III devices exempted from the obligation to perform clinical investigations

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

High obligation Framework Medical Devices & IVD EU-wide Medical devicesClinical evaluationCE marking
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