Category: Medicines and Healthcare Products Regulatory Agency – MHRA
New information about upcoming MDR and IVDR regulations added to the page – Medical devices: guidance for manufacturers on vigilance
Recommendations from the independent Expert Advisory Group on the use of Paclitaxel Drug-Coated Balloons (DCBs) and Drug-Eluting Stents (DESs) to the MHRA
Virtual manufacturing of medical devices.
Escopo da BSI para o MDR – Regulation (EU) 2017/745 on medical devices http://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=notification.pdf&dir_id=34&ntf_id=288798
MHRA response to EU exit no-deal legislative proposals consultation
After loosing the CE Mark and the ANSM recall – MHRA statement on Allergan
MHRA – Field safety notices – 03 to 07 December 2018. As a reminder, as part of Post Market Surveillance (PMS), manufacturers should track field safety notices to verify if similar devices had problems, and if the case, investigate if their device can also suffer from the same problem (and take action related to that). […]