Category: Medical Device

MHRA Guidance for Medical Device Manufacturers on Vigilance

October 26, 2022
Medical Device

Adverse incidents involving medical devices that occur in the UK must be reported to the Medicines and Healthcare products Regulatory Agency (MHRA). Once a medical device has been placed on the UK...

Medical Devices–USA/Europe Regulatory Updates Roundup, August 2022

September 27, 2022
Medical Device

EUROPE MDCG 2022-14 – Transition to the MDR and IVDR – Notified body capacity and availability of medical devices and IVDs This document has been endorsed by the Medical Device Coordination...

Medical Devices – USA/Europe Regulatory Updates round up Dec-2021

January 11, 2022
Medical Device

EUROPECommission Implementing Regulation (EU) 2021/2226 of 14 December 2021 laying down rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council as regards...

Canada regulatory updates, Europe Regulatory Updates, Medical Devices, Regulatory Updates, US FDA

Medical Device Patient Information Leaflets and Implant Cards

December 24, 2021
Medical Device

From 1st December 2021, all Implantable and Active Implantable Medical Devices (AIMD) are required to have patient information materials available in the form of both Patient Information Leaflets (PILs)...

mdr implant card requirements, Patient information card, patient information leaflet mdr

Medical Devices–Asia Regulatory Updates Roundup–Nov 2021

December 15, 2021
Medical Device

Japan(PMDA) MHLW Pharmaceuticals and Medical Devices Safety Information (FY2021) No. 387 At the This Pharmaceuticals and Medical Devices Safety Information (PMDSI) publication is issued reflective...

Asia Regulatory Updates, asia regulatory updates roundup, clinical consulting services to biopharma, medical device companies, Medical Devices, Regulatory Updates

Reclassification of Spinal Implantable Medical Devices

December 3, 2021
Medical Device

This guidance is to assist sponsors and manufacturers of spinal implantable medical devices to understand and comply with new regulatory requirements. All spinal implantable medical devices are...

changes to medical devices, Medical Devices, new regulatory requirements, quality management systems, spinal implantable medical devices, technical documentation related to each device