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Industry Newsletters Regulatory Affairs Newsletter Archive

TGA – Understanding how we regulate software-based medical devices Industry Newsletters Regulatory Affairs NewsletterIndustry Newsletters Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

TGA – Understanding how we regulate software-based medical devices

Dear Members, TGA Australia have updated guidance on Understanding how we regulate software-based medical devices Guidance on how we regulate software-based medical devices. View article...
Ben Kemp
March 13, 2026
The Digital Markets, Competition and Consumers Act 2024 (Alternative Dispute Resolution) (Conferral of Functions) Regulations 2026 Industry Newsletters Regulatory Affairs NewsletterIndustry Newsletters Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

The Digital Markets, Competition and Consumers Act 2024 (Alternative Dispute Resolution) (Conferral of Functions) Regulations 2026

The Digital Markets, Competition and Consumers Act 2024 (Alternative Dispute Resolution) (Conferral of Functions) Regulations 2026 These Regulations confer functions on the Chartered Trading Standards Institute (“the CTSI”) in relation to alternative dispute resolution for consumer contract disputes under the Digital Markets, Competition and Consumers Act 2024 (c. 13) (“the Act”), and make provisions in connection with the conferral of…
Ben Kemp
March 13, 2026
One IPO update – changes to patent paper forms Industry Newsletters Regulatory Affairs NewsletterIndustry Newsletters Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

One IPO update – changes to patent paper forms

One IPO update - changes to patent paper forms   We’re continuing our work to modernise and simplify the way customers interact with the Intellectual Property Office as we prepare for the launch of our new One IPO Patent Service. The latest blog in our What’s changing series looks at how patent paper forms are changing, and what this means…
Ben Kemp
March 13, 2026
HRA Now – New process to make it easier to set up research involving health and social care staff as participants Industry Newsletters Regulatory Affairs NewsletterIndustry Newsletters Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

HRA Now – New process to make it easier to set up research involving health and social care staff as participants

What: we are introducing a new proportionate process to make it easier to set up research involving health and social care staff as participants in the UK Who: sponsors, researchers, NHS and HSC organisations in England, Wales, Scotland and Northern Ireland When: the new process comes into effect on Tuesday 10 March 2026 We are introducing a new process to help streamline the application…
Ben Kemp
March 13, 2026
The Medical Devices (Fees Amendment) Regulations 2026 Industry Newsletters Regulatory Affairs NewsletterIndustry Newsletters Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

The Medical Devices (Fees Amendment) Regulations 2026

Dear members, as previously discussed regarding the changes to the MHRA fees, the proposal has now been adopted in law, amending the UK MDR 2002 (as amended) and the Medical Device (Northern Ireland Protocol) Regulations 2021 The Medical Devices (Fees Amendment) Regulations 2026 These Regulations make amendments to the Medical Devices Regulations 2002 (“the 2002 Regulations”) and the Medical Devices…
Ben Kemp
March 9, 2026
IMDRF – Clinical Evidence for IVD Medical Devices – Definitions and Principles of Performance Evaluation Industry Newsletters Regulatory Affairs NewsletterIndustry Newsletters Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

IMDRF – Clinical Evidence for IVD Medical Devices – Definitions and Principles of Performance Evaluation

Dear Members, please be advised that IMDRF have published their consultation on Clinical Evidence for IVD Medical Devices – Definitions and Principles of Performance Evaluation. View article...
Ben Kemp
March 9, 2026
CLSI Standard PRE06 – Evaluation of External Transport Systems Industry Newsletters Regulatory Affairs NewsletterIndustry Newsletters Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

CLSI Standard PRE06 – Evaluation of External Transport Systems

Dear Members, CLSI have published a new standard for evaluation of external transport systems. This is a laboratory focused standard. PRE06 | Evaluation of External Transport Systems Abstract CLSI PRE06—Evaluation of External Transport Systems describes processes for evaluating an external transport system. Specimens are commonly transported from external, off-site locations to the laboratory, where they are eventually examined. The system…
Ben Kemp
March 5, 2026
Your latest One IPO Patent Service update! Industry Newsletters Regulatory Affairs NewsletterIndustry Newsletters Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

Your latest One IPO Patent Service update!

The One IPO Patent Service is launching on 31 March 2026. Here are the latest updates to keep our patent customers informed: What to expect when the One IPO Patent Service launches Today we have published an update on what our patent customers can expect as we approach the launch of the new service on 31 March. Find out more:…
Ben Kemp
March 5, 2026
Considerations for the selection of IMDRF Adverse Event Terminology – A Guide for Industry Partners and Healthcare Providers Industry Newsletters Regulatory Affairs NewsletterIndustry Newsletters Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

Considerations for the selection of IMDRF Adverse Event Terminology – A Guide for Industry Partners and Healthcare Providers

Dear Members, IMDRF have issued Industry guidance on the considerations for the selection of IMDRF Adverse Event Terminology  N86: Final 2026 It includes examples of which 8, 12 and 18 are specific to IVDs. Considerations for the selection of IMDRF Adverse Event Terminology – A Guide for Industry Partners and Healthcare Providers View article...
Ben Kemp
March 5, 2026