Two Commission Delegated Regulations concerning exemptions applying to some implantable devices and Class III devices
Exemptions, Implantable Medical Devices Elisabethann Wright Exemptions, Implantable Medical Devices Elisabethann Wright

Two Commission Delegated Regulations concerning exemptions applying to some implantable devices and Class III devices

Two Commission Delegated Regulations concerning exemptions applying to some implantable devices and Class III devices were published in today’s Official Journal of the European Union, 19 June 2026. have just been published.

Article 52.4 of the MDR requires, with limited exceptions, that each Class IIb implantable device be the subject of an individual conformity assessment. Article 52.5 of the Regulation provides an exemption

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UK Regulations Governing Post-Market Surveillance of Medical Devices Enter Into Force
Medical Devices, Post-Market Surveillance, MHRA, In Vitro Diagnostic, Implantable Medical Devices Elisabethann Wright Medical Devices, Post-Market Surveillance, MHRA, In Vitro Diagnostic, Implantable Medical Devices Elisabethann Wright

UK Regulations Governing Post-Market Surveillance of Medical Devices Enter Into Force

The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024 entered into force on 16 June 2024. The Regulations, which apply in Great Britain, introduce a new Part 4A to the existing Regulations governing post-market surveillance (PMS) requirements for medical devices. These include in vitro diagnostic (IVD) devices and active implantable medical devices.

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