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ConsultationsConsultations Archive

Consultation response – Proposals for changes to the Medicines and Healthcare products Regulatory Agency’s statutory fees

The MHRA led on a joint consultation on proposed amendments to the MHRA’s statutory fees with the Department of Health in Northern Ireland, in accordance with Section 45(1) of the Medicines and Medical Devices Act 2021. The consultation ran between 31 August and 23 November 2022 to seek views on proposals to update the statutory fees charged for the MHRA’s…
Natalie Creaney
February 3, 2023
ConsultationsConsultations Archive

BS EN 556-2 EN 556-2 Sterilization of medical devices. Requirements for medical devices to be designated ”STERILE”. Part 2: requirements for aseptically processed medical devices

This document specifies the requirements for an aseptically processed medical device to be designated 'STERILE'. Please comment by 14 March 2023. To access the full document, click here. NOTE For the purpose of the EU Directive(s) for medical devices (see Bibliography), designating that a medical device is 'STERILE' is permissible when a validated manufacturing and sterilization process has been applied. Requirements…
Ben Kemp
January 27, 2023
ConsultationsConsultations Archive

BS EN 556-1 EN 556-1 Sterilization of medical devices. Requirements for medical devices to be designated “STERILE”. Part 1: Requirements for terminally sterilized medical devices

This document specifies the requirements for a terminally sterilized medical device to be designated ‘STERILE’. Part 2 of this European standard specifies the requirements for an aseptically processed medical device to be designated “STERILE”. Comments can be submitted until 14 March 2023. For the full document, please click here. NOTE For the purpose of the EU Directive(s) for medical devices (see…
Ben Kemp
January 27, 2023
ConsultationsConsultations Archive

ISO/NP TS 20510 Guidelines to use synthetic biological reference materials for nanoscale imaging by electron microscopy for life sciences and clinical diagnostics

This document provides an overview of measurement procedures for biological sample analysis using electron microscopy. This is exemplified by synthetic nanoscale biological materials that have undergone a series of inter-laboratory comparisons and is offered as the first metrologically traceable biological reference material for the characterisation of biological and patient biopsy specimen using electron microscopy. An emphasis is also made on…
Ben Kemp
January 27, 2023