Skip to main content
search
Category

Regulatory Affairs Newsletter

Industry Newsletters Regulatory Affairs NewsletterIndustry Newsletters Regulatory Affairs Newsletter Archive

BSI receives UKAS accreditation for ISO/IEC 27001:2022

BSI has received UKAS accreditation for ISO/IEC 27001:2022. ISO/IEC 27001- Information Security Management (ISMS) assists organizations in effectively managing and protecting their information assets, so that they remain safe. All ISO/IEC 27001:2022 certificates issued by BSI can now be accredited by the United Kingdom Accreditation Service. More information on ISO/IEC 27001:2022 can be found here.
admin
June 23, 2023
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

New Statutory Instrument to extend market access for Medical Devices in Great Britain

The UK Parliament have published Statutory Instruments 2023 No. 627 “The Medical Devices (Amendment) (Great Britain) Regulations 2023” to amend the UK Medical Devices Regulations (MDR) 2002 (S.I. 2002/618). The purpose of the amendment is “to extend the periods for which certain medical devices that comply with EU legislation can be placed on the market in Great Britain.” This SI will…
admin
June 23, 2023
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DBT weekly update (WC 05 June)

Please note this is an extract of the original bulletin. Procurement at DBT Page summary: DBT’s purchasing arrangements and information for those looking to become a supplier or contractor. Change made: First published. The UK’s trade agreements Page summary: Find out which trade agreements the UK has signed and which the UK is negotiating. Change made: ‘Trade with Maldives: call…
admin
June 16, 2023
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA weekly update (WC 05 June)

Please note this is an extract of the original bulletin. Register medical devices to place on the market Page summary: How to register your medical devices with the Medicines and Healthcare products Regulatory Agency (MHRA) for the markets in Great Britain and Northern Ireland Change made: Reference guides and the videos ‘update devices and update products individually’ and ‘review and…
admin
June 16, 2023
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DHSC weekly update (WC 05 June)

Please note this is an extract of the original bulletin. Health Infrastructure Plan: selection process for the next 8 new hospitals Page summary: The Department of Health and Social Care invited expressions of interests from mental health, community and acute NHS trusts who wished to be considered for inclusion in this next wave of the programme. Change made: Updated to…
admin
June 16, 2023
European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter Archive

Formal stakeholder body created under the Health Technology Assessment Regulation

The Health Technology Assessment Stakeholder Network had its first meeting in Brussels on June 14th, where a formal stakeholder body under the Health Technology Assessment Regulation was created. There were representatives from stakeholder organisations and Member States in the Health Technology Assessment Coordination Group. This meeting was an opportunity to discuss the role of stakeholders in the implementation of the…
admin
June 16, 2023
European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter Archive

EU Harmonisation of standards update

The European Commission's Directorate-General presented at the Medical Device Coordination Group (MDCG) – Subgroup meeting on Standards, held on 12 June 2023. The presentation and the meeting minutes will be published in the Register of Commission Expert Groups and Other Similar Entities, once approved by the members.
admin
June 16, 2023
Close Menu