--- title: Medical Device Regulations Blog | Alec Denniff, Medical Device Paralegal (2) description: All the news on Medical Device Regulations around the globe (2) --- [Skip to content](https://www.regtik.com/mdrblog/author/alec-denniff-medical-device-paralegal/page/2#main-content) [![LOGO with text Syntacog](https://www.regtik.com/hs-fs/hubfs/LOGO%20with%20text%20Syntacog.png?width=200&height=141&name=LOGO%20with%20text%20Syntacog.png)](https://www.regtik.com) - [Medical Devices](https://www.regtik.com/medical-devices) - [Blog](https://www.regtik.com/mdrblog) - [Newsletter](https://www.regtik.com/news) - [Contact Us](https://www.regtik.com/contact-us) Open main navigation Close main navigation - [Medical Devices](https://www.regtik.com/medical-devices) - [Blog](https://www.regtik.com/mdrblog) - [Newsletter](https://www.regtik.com/news) - [Contact Us](https://www.regtik.com/contact-us) - [Sign Up](https://app.regtik.com/users/log_in) [Sign Up](https://app.regtik.com/users/log_in) # Articles by Alec Denniff, Medical Device Paralegal [![](https://www.regtik.com/hs-fs/hubfs/markus-spiske-iar-afB0QQw-unsplash.jpg?width=365&name=markus-spiske-iar-afB0QQw-unsplash.jpg)](https://www.regtik.com/mdrblog/uk-government-to-update-regulations-on-software-and-ai-as-medical-devices) Nov 4, 2022 10:54:22 AM ## [UK to update regulations on Software and AI](https://www.regtik.com/mdrblog/uk-government-to-update-regulations-on-software-and-ai-as-medical-devices) Last September, the Medicines & Healthcare products Regulatory Agency (MHRA) [launched a change...](https://www.gov.uk/government/publications/software-and-ai-as-a-medical-device-change-programme) [![](https://www.regtik.com/hs-fs/hubfs/Ecology%20concept%20with%20green%20tree%20inside%20of%20light%20bulb-1.jpeg?width=365&name=Ecology%20concept%20with%20green%20tree%20inside%20of%20light%20bulb-1.jpeg)](https://www.regtik.com/mdrblog/uk-government-outlines-plans-to-improve-environmental-impact-and-sustainability-of-medical-devices-following-responses-to-mhra-consultation) Nov 4, 2022 10:44:28 AM ## [UK targets environmental impact of medical devices](https://www.regtik.com/mdrblog/uk-government-outlines-plans-to-improve-environmental-impact-and-sustainability-of-medical-devices-following-responses-to-mhra-consultation) The UK government has outlined plans to reduce the environmental impact and sustainability of... [![](https://www.regtik.com/hs-fs/hubfs/a%20dna%20in%20medical%20colour%20background.jpeg?width=365&name=a%20dna%20in%20medical%20colour%20background.jpeg)](https://www.regtik.com/mdrblog/changes-to-the-classification-rules-for-ivds-in-the-uk-expected-in-2023) Oct 26, 2022 8:30:00 AM ## [UK to align with IMDRF on IVD classification](https://www.regtik.com/mdrblog/changes-to-the-classification-rules-for-ivds-in-the-uk-expected-in-2023) On June 26 2022, the UK government published its response to the Medicines and Healthcare products... [![](https://www.regtik.com/hs-fs/hubfs/Businessman%20on%20ladder%20pointing%20at%20sandglass%20picture%20on%20wall.jpeg?width=365&name=Businessman%20on%20ladder%20pointing%20at%20sandglass%20picture%20on%20wall.jpeg)](https://www.regtik.com/mdrblog/mhra-new-uk-mdr-now-postponed-to-july-2024) Oct 24, 2022 4:20:01 PM ## [MHRA: New UK MDR now postponed to July 2024](https://www.regtik.com/mdrblog/mhra-new-uk-mdr-now-postponed-to-july-2024) The Medicines and Healthcare products Regulatory Agency (MHRA) - the national regulator for medical... [![](https://www.regtik.com/hs-fs/hubfs/Risk%20Ahead%20blue%20road%20sign.jpeg?width=365&name=Risk%20Ahead%20blue%20road%20sign.jpeg)](https://www.regtik.com/mdrblog/june-2023-target-date-for-new-uk-medical-devices-regulations-looking-ever-more-unrealistic-warns-head-of-abhi) Oct 21, 2022 8:30:00 AM ## [ABHI: June target for new UK MDR looking "ever more unrealistic"](https://www.regtik.com/mdrblog/june-2023-target-date-for-new-uk-medical-devices-regulations-looking-ever-more-unrealistic-warns-head-of-abhi) Peter Ellingworth – Chief Executive of the [Association of British HealthTech Industries](https://www.abhi.org.uk/) (ABHI)... [![](https://www.regtik.com/hs-fs/hubfs/3D%20football%20with%20the%20flag%20of%20Australia%20-%20isolated%20over%20a%20white%20background.jpeg?width=365&name=3D%20football%20with%20the%20flag%20of%20Australia%20-%20isolated%20over%20a%20white%20background.jpeg)](https://www.regtik.com/mdrblog/tga-seeking-views-on-draft-guidance-boundary-and-combination-products-medicines-medical-devices-and-biologicals) Oct 20, 2022 5:18:30 PM ## [Australian TGA consults on draft borderlines guidance](https://www.regtik.com/mdrblog/tga-seeking-views-on-draft-guidance-boundary-and-combination-products-medicines-medical-devices-and-biologicals) The Therapeutic Goods Administration (TGA) – the national regulator for medical devices in... [![](https://www.regtik.com/hs-fs/hubfs/What%20Are%20The%20Rules%3F%20written%20on%20a%20chalkboard.jpeg?width=365&name=What%20Are%20The%20Rules%3F%20written%20on%20a%20chalkboard.jpeg)](https://www.regtik.com/mdrblog/european-commission-publishes-draft-implementing-regulation-to-reclassify-non-medical-active-products) Oct 18, 2022 8:00:00 AM ## [European Commission publishes draft implementing regulation to reclassify non-medical active products](https://www.regtik.com/mdrblog/european-commission-publishes-draft-implementing-regulation-to-reclassify-non-medical-active-products) The European Commission has published an [initiative](https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/12972-Medical-devices-reclassification-of-products-without-an-intended-medical-purpose_en) to ensure that active products without a... [![](https://www.regtik.com/hs-fs/hubfs/Studio%20macro%20of%20a%20stethoscope%20and%20digital%20tablet%20with%20shallow%20DOF%20evenly%20matched%20abstract%20on%20wood%20table%20background%20copy%20space.jpeg?width=365&name=Studio%20macro%20of%20a%20stethoscope%20and%20digital%20tablet%20with%20shallow%20DOF%20evenly%20matched%20abstract%20on%20wood%20table%20background%20copy%20space.jpeg)](https://www.regtik.com/mdrblog/borderlines-between-medical-devices-and-medicinal-products-in-the-eu) Oct 7, 2022 2:30:00 PM ## [Borderlines between medical devices and medicinal products in the EU](https://www.regtik.com/mdrblog/borderlines-between-medical-devices-and-medicinal-products-in-the-eu) The Medical Device Coordination Group (MDCG) - a working group of the European Commission, recently... [![](https://www.regtik.com/hs-fs/hubfs/Audit%20Concept.%20Word%20on%20Folder%20Register%20of%20Card%20Index.%20Selective%20Focus..jpeg?width=365&name=Audit%20Concept.%20Word%20on%20Folder%20Register%20of%20Card%20Index.%20Selective%20Focus..jpeg)](https://www.regtik.com/mdrblog/what-is-mdsap-everything-you-need-to-know-about-the-mdsap-program) Jul 19, 2022 9:45:00 AM ## [What is MDSAP? Everything you need to know about the MDSAP program](https://www.regtik.com/mdrblog/what-is-mdsap-everything-you-need-to-know-about-the-mdsap-program) The Medical Device Single Audit Program (MDSAP) was created in 2012 by the [International Medical...](https://www.imdrf.org/working-groups/medical-device-single-audit-program-mdsap) [![](https://www.regtik.com/hs-fs/hubfs/Gavel%20resting%20on%20sound%20block%20with%20european%20union%20flag%20in%20background.jpeg?width=365&name=Gavel%20resting%20on%20sound%20block%20with%20european%20union%20flag%20in%20background.jpeg)](https://www.regtik.com/mdrblog/european-commission-updates-harmonised-standards) May 17, 2022 11:09:00 PM ## [European Commission updates Harmonised Standards](https://www.regtik.com/mdrblog/european-commission-updates-harmonised-standards) The European Commission has published a second series of amendments to the original lists of... [1](https://www.regtik.com/mdrblog) [2](https://www.regtik.com/mdrblog/author/alec-denniff-medical-device-paralegal/page/2) [3](https://www.regtik.com/mdrblog/author/alec-denniff-medical-device-paralegal/page/3) [![LOGO white](https://www.regtik.com/hs-fs/hubfs/LOGO%20white.png?width=200&height=141&name=LOGO%20white.png "LOGO white")](https://www.syntacog.com) Making regulatory compliance simple #### Services - Medical Device Qualification - Medical Device Classification - Regulatory Pathways - Regulatory Strategy - Consulting #### Contact - +44 (0) 203 026 5881 - info@syntacog.com - [7 Bell Yard, London WC2A 2JR, England, United Kingdom](https://goo.gl/maps/sdTcKjFxWk1ySx1UA) - [LinkedIn](https://www.linkedin.com/company/syntacog-ltd)