---
title: Medical Device Regulations Blog (4)
description: All the news on Medical Device Regulations around the globe (4)
---

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# Medical Device Regulations Blog

[![](https://www.regtik.com/hs-fs/hubfs/Businessman%20with%20office%20symbol%20concept%20and%20little%20flag%20on%20his%20hand-1.jpeg?width=365&name=Businessman%20with%20office%20symbol%20concept%20and%20little%20flag%20on%20his%20hand-1.jpeg)](https://www.regtik.com/mdrblog/mdcg-clarifies-obligations-and-liability-of-authorised-representatives-under-mdr-and-ivdr)

 Nov 29, 2022 10:18:06 AM

## [Authorised representatives under MDR/IVDR – new MDCG guidance](https://www.regtik.com/mdrblog/mdcg-clarifies-obligations-and-liability-of-authorised-representatives-under-mdr-and-ivdr)

The Medical Devices Coordination Group (MDCG) has issued [new guidance](https://health.ec.europa.eu/system/files/2022-10/mdcg_202216_en.pdf) on authorised representatives...

[![](https://www.regtik.com/hs-fs/hubfs/Business%20woman%20typing%20on%20keyboard%20with%20global%20system%20concept-1.jpeg?width=365&name=Business%20woman%20typing%20on%20keyboard%20with%20global%20system%20concept-1.jpeg)](https://www.regtik.com/mdrblog/commission-targets-spring-2024-for-fully-functionality-of-eudamed)

 Nov 22, 2022 9:43:58 AM

## [Spring 2024 target for EUDAMED](https://www.regtik.com/mdrblog/commission-targets-spring-2024-for-fully-functionality-of-eudamed)

The European Commission has released an updated [EUDAMED timeline](https://health.ec.europa.eu/system/files/2022-07/md_eudamed_timeline_en.pdf), targeting the second quarter of...

[![](https://www.regtik.com/hs-fs/hubfs/Waving%20Australian%20flag%20in%20Melbourne.jpeg?width=365&name=Waving%20Australian%20flag%20in%20Melbourne.jpeg)](https://www.regtik.com/mdrblog/australian-tga-to-recognise-medical-device-assessments-from-singapores-health-sciences-authority)

 Nov 7, 2022 8:00:00 AM

## [Australian TGA to recognise approvals from Singapore’s HSA](https://www.regtik.com/mdrblog/australian-tga-to-recognise-medical-device-assessments-from-singapores-health-sciences-authority)

Australia’s Therapeutic Goods Administration, the national regulator for medical devices, has...

[![](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/Laboratory%20Pipette%20with%20Blue%20Liquid%20Over%20Glass%20Test%20Tubes.-1.jpeg?width=365&name=Laboratory%20Pipette%20with%20Blue%20Liquid%20Over%20Glass%20Test%20Tubes.-1.jpeg)](https://www.regtik.com/mdrblog/fda-scales-back-on-euas-for-covid-19-tests)

 Oct 31, 2022 6:40:21 PM

## [FDA scales back C-19 EUAs](https://www.regtik.com/mdrblog/fda-scales-back-on-euas-for-covid-19-tests)

The FDA has recently announced a scaling back of Emergency Use Authorisations (EUAs) for Covid-19...

[![](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/Concept%20of%20human%20intelligence%20with%20human%20brain%20on%20blue%20background.jpeg?width=365&name=Concept%20of%20human%20intelligence%20with%20human%20brain%20on%20blue%20background.jpeg)](https://www.regtik.com/mdrblog/how-the-eus-new-ai-laws-will-impact-your-medical-device)

 Oct 24, 2022 4:23:02 PM

## [How the EU’s new AI laws will impact your medical device](https://www.regtik.com/mdrblog/how-the-eus-new-ai-laws-will-impact-your-medical-device)

The EU is currently in the process of negotiating a new framework for regulating artificial...

[![](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)...

[2](https://www.regtik.com/mdrblog/page/2) [3](https://www.regtik.com/mdrblog/page/3) [4](https://www.regtik.com/mdrblog/page/4) [5](https://www.regtik.com/mdrblog/page/5) [6](https://www.regtik.com/mdrblog/page/6)

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