--- title: Medical Device Regulations Blog | EU description: EU | All the news on Medical Device Regulations around the globe --- [Skip to content](https://www.regtik.com/mdrblog/tag/eu#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 EU [![](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/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/louis-reed-pwcKF7L4-no-unsplash.jpg?width=365&name=louis-reed-pwcKF7L4-no-unsplash.jpg)](https://www.regtik.com/mdrblog/new-guidance-on-technical-documentation-for-ivds) Mar 7, 2023 9:53:41 PM ## [New guidance on technical documentation for IVDs](https://www.regtik.com/mdrblog/new-guidance-on-technical-documentation-for-ivds) The European Association for Medical devices of Notified Bodies (Team-NB) has issued a new [guidance...](https://www.team-nb.org/team-nb-pp-best-practice-guidance-for-the-submission-of-technical-documentation-under-annex-ii-and-iii-of-in-vitro-diagnostic-medical-devices-regulation/) [![](https://www.regtik.com/hs-fs/hubfs/guillaume-perigois-0NRkVddA2fw-unsplash%202-2.jpg?width=365&name=guillaume-perigois-0NRkVddA2fw-unsplash%202-2.jpg)](https://www.regtik.com/mdrblog/european-parliament-approves-extended-transition-period-for-mdr) Feb 21, 2023 2:50:31 PM ## [European Parliament approves extended transition period for MDR](https://www.regtik.com/mdrblog/european-parliament-approves-extended-transition-period-for-mdr) The European Parliament has voted overwhelmingly to extend transition periods for the Medical... [![](https://www.regtik.com/hs-fs/hubfs/Public%20Health.%20Medical%20Concept%20with%20Blurred%20Text%2c%20Stethoscope%2c%20Pills%20and%20Syringe%20on%20Grey%20Background.%20Selective%20Focus..jpeg?width=365&name=Public%20Health.%20Medical%20Concept%20with%20Blurred%20Text%2c%20Stethoscope%2c%20Pills%20and%20Syringe%20on%20Grey%20Background.%20Selective%20Focus..jpeg)](https://www.regtik.com/mdrblog/mdcg-publishes-guidance-on-health-institution-exemption-under-eu-mdr-/-ivdr) Feb 20, 2023 7:15:00 AM ## [MDCG publishes guidance on health institution exemption](https://www.regtik.com/mdrblog/mdcg-publishes-guidance-on-health-institution-exemption-under-eu-mdr-/-ivdr) The Medical Devices Coordination Group (MDCG) has published guidance discussing the health... [![](https://www.regtik.com/hs-fs/hubfs/markus-spiske-70Rir5vB96U-unsplash%202-1.jpg?width=365&name=markus-spiske-70Rir5vB96U-unsplash%202-1.jpg)](https://www.regtik.com/mdrblog/what-are-the-nis-2-cybersecurity-requirements-for-medical-devices) Feb 17, 2023 7:30:00 AM ## [What are the NIS 2 cybersecurity requirements for medical devices?](https://www.regtik.com/mdrblog/what-are-the-nis-2-cybersecurity-requirements-for-medical-devices) The new EU [Network and Information Systems (NIS 2) Directive](https://eur-lex.europa.eu/eli/dir/2022/2555) entered into force on 16 January 2023.... [![](https://www.regtik.com/hs-fs/hubfs/Facial%20recognition%20biometric%20technology%20and%20artificial%20intelligence%20concept..jpeg?width=365&name=Facial%20recognition%20biometric%20technology%20and%20artificial%20intelligence%20concept..jpeg)](https://www.regtik.com/mdrblog/team-notified-body-issues-position-paper-discussing-notified-bodies-under-upcoming-eu-ai-act) Jan 19, 2023 8:00:00 AM ## [Team-NB issues position paper discussing Notified Bodies under upcoming EU AI Act](https://www.regtik.com/mdrblog/team-notified-body-issues-position-paper-discussing-notified-bodies-under-upcoming-eu-ai-act) Team Notified Body (Team-NB) – the European Association of Notified Bodies active in the medical... [![](https://www.regtik.com/hs-fs/hubfs/The%20exterior%20of%20Hofburg%20Palace%2c%20in%20Vienna%2c%20Austria..jpeg?width=365&name=The%20exterior%20of%20Hofburg%20Palace%2c%20in%20Vienna%2c%20Austria..jpeg)](https://www.regtik.com/mdrblog/eighth-ivdr-notified-body-designated) Jan 17, 2023 10:39:46 AM ## [Eighth IVDR Notified Body designated](https://www.regtik.com/mdrblog/eighth-ivdr-notified-body-designated) Last month QMD Services GmbH was designated a Notified Body under Regulation 2017/746 on in-vitro... [![](https://www.regtik.com/hs-fs/hubfs/Background%20image%20with%20financial%20charts%20and%20graphs%20on%20media%20backdrop.jpeg?width=365&name=Background%20image%20with%20financial%20charts%20and%20graphs%20on%20media%20backdrop.jpeg)](https://www.regtik.com/mdrblog/mdcg-issues-version-2-of-the-borderline-and-classification-manual) Jan 17, 2023 10:34:54 AM ## [MDCG issues version 2 of the Borderline and Classification Manual](https://www.regtik.com/mdrblog/mdcg-issues-version-2-of-the-borderline-and-classification-manual) The Medical Device Coordination Group (MDCG) – a working group of the European Commission – has... 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