Skip to main content
search
Category

Regulatory Affairs Newsletter

FDA updates Regulatory Affairs NewsletterFDA Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

FDA Classification update

FDA have updated their classification codes for devices intended: To detect and identify nucleic acid targets including SARS-CoV-2 in respiratory specimens (Class II with special controls), To detect and identify selected microbial agents that cause acute febrile illness (Class II with special controls)
Ben Kemp
August 20, 2024
BIVDA updates Regulatory Affairs NewsletterBIVDA Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

WHO consults on collaborative registration procedures guideline

The World Health Organization (WHO) has released a draft version of its updated guideline on practices for national regulatory authorities’ (NRAs) implementation of collaborative registration procedures (CRP) to facilitate the marketing authorization of new medical products within their jurisdictions for products that have either been WHO-prequalified or approved by a stringent regulatory authority. Read more here.
Ben Kemp
August 14, 2024
European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

(EU) 2024/2120 published

"(EU) 2024/2120 - renewing the designation of issuing entities designated to operate a system for the assignment of Unique Device Identifiers (UDIs) in the field of medical devices" published. This reestablishes the following four entities as UDI issuing entities. GSI HIBCC ICCBBA IFA
Ben Kemp
August 14, 2024
European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

17 Oct deadline for member states to implement EU Directive 2022/2555

17th October 2024 is the deadline for EU member states to implement the EU Directive 2022/2555 EUR-Lex - 02022L2555-20221227 - EN - EUR-Lex (europa.eu) on measures for a high common level of cybersecurity across the Union, amending Regulation (EU) 910/214 and Directive (EU) 2018/1972, and repealing Directive (EU) 2016/1148 (NIS 2 Directive). NIS 2 widens the scope of services covered…
Ben Kemp
August 14, 2024
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA Updates (WC 12 Aug)

Notify MHRA about a clinical investigation for a medical device Page summary: How to notify the MHRA of your intention to carry out a clinical investigation for medical devices. Change made: New section ‘Regulatory advice meetings’ added to this page. Time updated: 11:45am, 5 August 2024 Medical devices given exceptional use authorisations during the COVID-19 pandemic Page summary: List of…
Ben Kemp
August 14, 2024
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DSIT Updates (WC 12 Aug)

Cyber security breaches survey: 2025 Page summary: An annual survey about the experience and impacts of cyber breaches and attacks on organisations. Change made: Added details and privacy notices for the 2025 survey. Time updated: 6:21pm, 5 August 2024 DSIT cyber security newsletter – August 2024 Page summary: The August 2024 edition of the DSIT cyber security newsletter. Change made:…
Ben Kemp
August 14, 2024
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DEFRA Updates (WC 12 Aug)

Persistent Organic Pollutants (POPs): policy information Page summary: Information on the Stockholm Convention on Persistent Organic Pollutants (POPs) and the UK’s obligations. Change made: First published. Time updated: 12:34pm, 7 August 2024 Persistent organic pollutants (POPs) Page summary: Information relating to persistent organic pollutants (POPs). Change made: First published. Time updated: 1:12pm, 7 August 2024 List of large producers on…
Ben Kemp
August 14, 2024
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DBT Updates (WC 12 Aug)

UK/Swiss Mutual Recognition covers conformity assessment testing for Radio Equipment, EMC and Electrical Safety testing. UK/New Zealand Mutual Recognition covers conformity assessment for medical devices (including IVDs): The Medical Devices Regulations 2002, machinery: The Supply of Machinery (Safety) Regulations 2008, low voltage equipment: The Electrical Equipment (Safety) Regulations 2016, pressure equipment: The Simple Pressure Vessels (Safety) Regulations 2016, The Radio…
Ben Kemp
August 14, 2024
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Brexit Updates (WC 12 Aug)

Search the register of customs agents and fast parcel operators Page summary: Find a customs agent or fast parcel operator to help you with import and export declarations. Change made: The list of customs agents has been updated with 2 additions, 1 amendment and 1 removal.
Ben Kemp
August 14, 2024
Close Menu