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Popular medical device archived news Below you will find links to our most popular medical device news: EN 60601-1: 2006 is now Harmonised under the Medical Electrical Equipment (MDD) Revision of the MDD and IVD medical devices regulations EN ISO 14971:2012 - what does it mean for Manufacturers placing products on the European Market? New Medical Devices Regulation and IVD Regulation text published BSI opening a second EU Notified Body based in the Netherlands MDR and IVDR Critical Update New Medical Devices Regulation and IVD Regulation text published BSI opening a second EU Notified Body based in the Netherlands BSI Netherlands Successfully Achieves Designation as a Medical Device Notified Body An update on Brexit and BSI Medical Device Notified Body: May 2018 BSI Medical Devices Brexit Update January 2018 BSI achieves designation to the In Vitro Diagnostics Regulation in the UK BSI achieves designation to the Medical Device Regulation for its Netherlands notified body BSI certifies first product to the Medical Devices Regulation BSI designated to the In Vitro Diagnostics Regulation in the Netherlands BSI first EU notified body to achieve designation to the Medical Device Regulation BSI Service update MDR update, Phthalates, eVigilance and Implant cards Clarification around UKAS ISO 13485 and no-deal Brexit ISO 13485 and products with May 2020 deadline for MDR certification The end of ISO 13485 transition Urgent BREXIT Implications for Market Access - less than 60 Days Out from 29 March 2019 Urgent: Class Ir – reusable surgical instruments with a deadline of May 2020 requiring MDR certification
