--- title: Medical Device Regulations Blog (2) description: All the news on Medical Device Regulations around the globe (2) --- [Skip to content](https://www.regtik.com/mdrblog/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) # Medical Device Regulations Blog [![](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/julia-zyablova-S1v7hVUiCg0-unsplash.jpg?width=365&name=julia-zyablova-S1v7hVUiCg0-unsplash.jpg)](https://www.regtik.com/mdrblog/home-use-medical-devices) Feb 27, 2023 8:45:00 AM ## [Developing medical devices for home use](https://www.regtik.com/mdrblog/home-use-medical-devices) The concept of ‘at home’ medical devices is certainly not new – medicine spoons, first aid kits and... [![](https://www.regtik.com/hs-fs/hubfs/tim-mossholder-zdV9ngtM0Sw-unsplash.jpg?width=365&name=tim-mossholder-zdV9ngtM0Sw-unsplash.jpg)](https://www.regtik.com/mdrblog/accelerated-pathways-for-innovative-medical-devices) Feb 22, 2023 8:15:00 AM ## [Accelerated pathways for innovative medical devices](https://www.regtik.com/mdrblog/accelerated-pathways-for-innovative-medical-devices) Bringing medical devices to market is a process that often takes years. Manufacturers are required... [![](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/testalize-me-0jE8ynV4mis-unsplash%202.jpg?width=365&name=testalize-me-0jE8ynV4mis-unsplash%202.jpg)](https://www.regtik.com/mdrblog/uk-increases-approved-body-capacity-for-ivds) Feb 14, 2023 2:34:50 PM ## [UK increases approved body capacity for IVDs](https://www.regtik.com/mdrblog/uk-increases-approved-body-capacity-for-ivds) The MHRA has extended the scope of UL International UK Limited’s approved body designation to... [![](https://www.regtik.com/hs-fs/hubfs/national-cancer-institute-NFvdKIhxYlU-unsplash%202.jpg?width=365&name=national-cancer-institute-NFvdKIhxYlU-unsplash%202.jpg)](https://www.regtik.com/mdrblog/is-your-software-a-medical-device) Jan 30, 2023 8:00:00 AM ## [Is your software a medical device?](https://www.regtik.com/mdrblog/is-your-software-a-medical-device) The regulation of medical device software and apps is a particularly complicated area. Such... [![](https://www.regtik.com/hs-fs/hubfs/Earth%20planet%20on%20grey%20background%20with%20pencil%20sketches.%20Elements%20of%20this%20image%20are%20furnished%20by%20NASA.jpeg?width=365&name=Earth%20planet%20on%20grey%20background%20with%20pencil%20sketches.%20Elements%20of%20this%20image%20are%20furnished%20by%20NASA.jpeg)](https://www.regtik.com/mdrblog/new-uk-proposals-on-international-recognition-expected-in-february) Jan 25, 2023 8:00:00 AM ## [New UK proposals on international recognition expected in February](https://www.regtik.com/mdrblog/new-uk-proposals-on-international-recognition-expected-in-february) The UK Life Sciences Council has issued a [statement](https://www.gov.uk/government/news/life-sciences-council-joint-statement-on-medical-devices-regulatory-reform) concerning their agreement to publish proposals... [![](https://www.regtik.com/hs-fs/hubfs/diabetesmagazijn-nl-z03Q6GAkqKM-unsplash%202.jpg?width=365&name=diabetesmagazijn-nl-z03Q6GAkqKM-unsplash%202.jpg)](https://www.regtik.com/mdrblog/emc-testing-for-wireless-medical-devices) Jan 23, 2023 8:00:00 AM ## [EMC testing for wireless medical devices](https://www.regtik.com/mdrblog/emc-testing-for-wireless-medical-devices) Wireless technology has become a common feature of the medical device industry. From wearables to... 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