--- title: Medical Device Regulations Blog (5) description: All the news on Medical Device Regulations around the globe (5) --- [Skip to content](https://www.regtik.com/mdrblog/page/5#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) # Medical Device Regulations Blog [![](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/Young%20woman%20touching%20future%20technology%20social%20network%20button.jpeg?width=365&name=Young%20woman%20touching%20future%20technology%20social%20network%20button.jpeg)](https://www.regtik.com/mdrblog/fda-clinical-decision-support-software-guidance) Oct 19, 2022 7:30:00 AM ## [FDA finalises guidance on clinical decision support software](https://www.regtik.com/mdrblog/fda-clinical-decision-support-software-guidance) The FDA has issued its long awaited [final guidance](https://www.fda.gov/media/109618/download) outlining how it intends to interpret the... [![](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/Flag%20of%20United%20Kingdom%20-%20Button%20on%20Black%20Computer%20Keyboard..jpeg?width=365&name=Flag%20of%20United%20Kingdom%20-%20Button%20on%20Black%20Computer%20Keyboard..jpeg)](https://www.regtik.com/mdrblog/dekra-joins-approved-body-list) Oct 10, 2022 8:00:00 AM ## [DEKRA joins UK Approved Body list](https://www.regtik.com/mdrblog/dekra-joins-approved-body-list) The Medicines and Healthcare products Regulatory Agency (MHRA) recently confirmed the appointment... [![](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/Pretty%20young%20woman%20making%20a%20decision%20with%20arrows%20and%20question%20mark%20above%20her%20head.jpeg?width=365&name=Pretty%20young%20woman%20making%20a%20decision%20with%20arrows%20and%20question%20mark%20above%20her%20head.jpeg)](https://www.regtik.com/mdrblog/what-is-a-medical-device-anyway) Oct 5, 2022 3:31:55 PM ## [What is a medical device anyway?](https://www.regtik.com/mdrblog/what-is-a-medical-device-anyway) One of the fundamental questions in medical device regulations (MDR) is whether a product is... [![](https://www.regtik.com/hs-fs/hubfs/Modern%20cyber%20woman%20with%20matrix%20eye%20concept.jpeg?width=365&name=Modern%20cyber%20woman%20with%20matrix%20eye%20concept.jpeg)](https://www.regtik.com/mdrblog/mhra-guidance-on-software-as-a-medical-device-samd-updated) Sep 11, 2022 11:14:00 PM ## [MHRA guidance on Software as a Medical Device (SaMD) updated](https://www.regtik.com/mdrblog/mhra-guidance-on-software-as-a-medical-device-samd-updated) Software as a medical device (SaMD) manufacturers operating in the UK should note the new... [![](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) [![Scientists at work in a laboratory with microscopes and other equipment](https://www.regtik.com/hs-fs/hubfs/Side%20view%20of%20busy%20group%20of%20researchers%20working%20on%20experiments%20in%20the%20laboratory.jpeg?width=365&name=Side%20view%20of%20busy%20group%20of%20researchers%20working%20on%20experiments%20in%20the%20laboratory.jpeg)](https://www.regtik.com/mdrblog/eu-ivdr-takes-effect) May 26, 2022 11:08:00 PM ## [EU IVDR takes effect](https://www.regtik.com/mdrblog/eu-ivdr-takes-effect) [![](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... [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) [![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)