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New guidance: Exceptional Use Authorisation How to apply for an exceptional use authorisation to place medical devices on the UK market.
Guidance update: Register medical devices to place on the market Multiple updates including; Updated account management and device registration reference guides. Inclusion of links to guidance for the EU IVDR transition extension under Article 110 for the registration of IVD devices with the MHRA. Clarification concerning maximum validity for Letter of Designation. Correction to countries that Northern Ireland Authorised Representatives can represent manufacturers from. Clarification that if registered device characteristics change this may require re-registration.

Guidance update: Register medical devices to place on the market Now includes guidance for the EU IVDR transition extension and updates to current guidance for medical device registration under the EU MDR transition extension.
Guidance update: Regulating medical devices in the UK Several updates; including guidance for the EU IVDR transition extension under Article 110 and the EU MDR transition extension under Article 120.
New guidance: Digital mental health technology: qualification and classification Help for manufacturers to define the characteristics of their devices and determine the appropriate regulatory qualification and classification.

New guidance: Medical devices: post-market surveillance requirements on how to interpret post-market surveillance (PMS) requirements for medical devices in Great Britain.
Guidance update: In vitro diagnostic medical devices: guidance on legislation updated to reflect The Medical Devices (Post-market Surveillance requirements) (Amendment) Regulations 2024.
Guidance update: Effective field safety notices (FSNs): guidance for manufacturers of medical devices Updated to reflect The Medical Devices (Post-market Surveillance requirements) (Amendment) Regulations 2024.
Guidance update: Regulation of devices in Northern Ireland The section ‘Clinical investigations and performance studies in Northern Ireland’ has been updated.
Guidance update: Guidance on applying human factors to medical devices Update reflecting The Medical Devices (Post-market Surveillance requirements) (Amendment) Regulations 2024.