2019 Medical device news and industry updates

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