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Commission Delegated Regulation (EU) 2026/1359 amending MDR as regards class IIb implantable devices exempted from technical documentation assessment
Original title: Commission Delegated Regulation (EU) 2026/1359 of 20 March 2026 amending Regulation (EU) 2017/745 of the European Parliament and of the Council as regards the list of class IIb implantable devices exempted from the obligation to perform an assessment of the technical documentation for every device
Amendment to MDR establishing exemptions from technical documentation assessment for specified class IIb implantable devices.