--- title: Medical Device Regulations Blog | Medical Device description: Medical Device | All the news on Medical Device Regulations around the globe --- [Skip to content](https://www.regtik.com/mdrblog/tag/medical-device/page/1#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 about Medical Device [![](https://www.regtik.com/hs-fs/hubfs/jonathan-kemper-5yuRImxKOcU-unsplash.jpg?width=365&name=jonathan-kemper-5yuRImxKOcU-unsplash.jpg)](https://www.regtik.com/mdrblog/is-chatgpt-a-medical-device) May 10, 2023 9:00:00 AM ## [Is ChatGPT a medical device?](https://www.regtik.com/mdrblog/is-chatgpt-a-medical-device) The term generative AI refers to systems which are capable of producing text, images, or other... [![](https://www.regtik.com/hs-fs/hubfs/cdc-LiNIONbajm4-unsplash%202.jpg?width=365&name=cdc-LiNIONbajm4-unsplash%202.jpg)](https://www.regtik.com/mdrblog/biocompatibility-for-medical-devices) May 2, 2023 8:30:00 AM ## [Biocompatibility for medical devices](https://www.regtik.com/mdrblog/biocompatibility-for-medical-devices) The term biocompatibility refers to the interaction between materials (i.e. in medical devices) and... [![](https://www.regtik.com/hs-fs/hubfs/thisisengineering-raeng-vx9PRVosHhs-unsplash%202.jpg?width=365&name=thisisengineering-raeng-vx9PRVosHhs-unsplash%202.jpg)](https://www.regtik.com/mdrblog/medical-device-qms-understanding-the-basics) Apr 25, 2023 3:48:27 PM ## [Medical device QMS – understanding the basics](https://www.regtik.com/mdrblog/medical-device-qms-understanding-the-basics) Establishing an effective quality management system (QMS) is a key requirement across a number of... [![](https://www.regtik.com/hs-fs/hubfs/guillaume-perigois-0NRkVddA2fw-unsplash%202-3.jpg?width=365&name=guillaume-perigois-0NRkVddA2fw-unsplash%202-3.jpg)](https://www.regtik.com/mdrblog/updates-on-the-eu-mdr-transition-period-extension) Apr 18, 2023 9:53:48 AM ## [Updates on the EU MDR transition period extension](https://www.regtik.com/mdrblog/updates-on-the-eu-mdr-transition-period-extension) Since December 2022, European regulatory bodies have been working to enact [Regulation 2023/607](https://eur-lex.europa.eu/eli/reg/2023/607/oj) to... [![](https://www.regtik.com/hs-fs/hubfs/ce-mark.jpg?width=365&name=ce-mark.jpg)](https://www.regtik.com/mdrblog/legacy-devices-under-the-eu-mdr/ivdr) Apr 3, 2023 8:00:00 AM ## [Legacy devices under the EU MDR/IVDR](https://www.regtik.com/mdrblog/legacy-devices-under-the-eu-mdr/ivdr) The EUs new regulatory framework for medical devices entered into force in May 2021. As part of its... [![](https://www.regtik.com/hs-fs/hubfs/waldemar-vJsTHrqMm94-unsplash-1.jpg?width=365&name=waldemar-vJsTHrqMm94-unsplash-1.jpg)](https://www.regtik.com/mdrblog/the-us-prepares-to-end-its-covid-19-phe-what-medical-device-manufacturers-should-know) Mar 29, 2023 12:00:00 PM ## [The US prepares to end its Covid-19 PHE – what medical device manufacturers should know](https://www.regtik.com/mdrblog/the-us-prepares-to-end-its-covid-19-phe-what-medical-device-manufacturers-should-know) The US Covid-19 public health emergency (PHE) is set to end on 11 May 2023. The PHE was initially... [![](https://www.regtik.com/hs-fs/hubfs/glenn-carstens-peters-RLw-UC03Gwc-unsplash.jpg?width=365&name=glenn-carstens-peters-RLw-UC03Gwc-unsplash.jpg)](https://www.regtik.com/mdrblog/new-harmonised-standards-for-medical-devices) Mar 27, 2023 8:00:00 AM ## [New harmonised standards for medical devices](https://www.regtik.com/mdrblog/new-harmonised-standards-for-medical-devices) Last month, the European Commission published an implementing decision announcing the future... [![](https://www.regtik.com/hs-fs/hubfs/adi-goldstein-EUsVwEOsblE-unsplash.jpg?width=365&name=adi-goldstein-EUsVwEOsblE-unsplash.jpg)](https://www.regtik.com/mdrblog/us-enhances-cybersecurity-requirements-for-medical-devices) Mar 21, 2023 10:05:50 PM ## [US enhances cybersecurity requirements for medical devices](https://www.regtik.com/mdrblog/us-enhances-cybersecurity-requirements-for-medical-devices) Towards the end of December last year, President Biden signed into law the Consolidated... [![](https://www.regtik.com/hs-fs/hubfs/towfiqu-barbhuiya-ZJaK9jQXeDA-unsplash.jpg?width=365&name=towfiqu-barbhuiya-ZJaK9jQXeDA-unsplash.jpg)](https://www.regtik.com/mdrblog/navigating-the-drug/device-borderline) Mar 15, 2023 8:45:00 AM ## [Navigating the drug/device borderline](https://www.regtik.com/mdrblog/navigating-the-drug/device-borderline) In January, the European Court of Justice (ECJ) published a new judgement on the medicine/medical... [![](https://www.regtik.com/hs-fs/hubfs/national-cancer-institute-L8tWZT4CcVQ-unsplash.jpg?width=365&name=national-cancer-institute-L8tWZT4CcVQ-unsplash.jpg)](https://www.regtik.com/mdrblog/operating-system-concerns-for-medical-apps) Mar 12, 2023 8:00:00 AM ## [Operating system concerns for medical apps](https://www.regtik.com/mdrblog/operating-system-concerns-for-medical-apps) The use of mobile medical apps has become increasingly prevalent in the past decade as smartphones... 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