[co-author: Silvia López Arnao]
On 11 January 2021, the European Commission published a Notice which provides the conditions under which remote audits under Regulation 2017/745 of 5 April 2017 on medical devices (MDR) and Regulation 2017/746 of the of 5 April 2017 on in vitro diagnostic medical devices (IVDR) may be performed. The European Commission recalls that this is a temporary extraordinary measure motivated by the unprecedented circumstances that the medical devices industry is experiencing due to COVID-19. The possibility of conducting remote audits will, therefore, be assessed on a case-by-case basis and will only be allowed until on-site audits are again possible.
Background for the Notice
Post-market surveillance for
medical devices: Amendments to the
Medical Devices
Regulations (MDR) are being made to impose additional
post-market reporting requirements for Class II, III and IV medical
devices.
Medical device license holders and
importers will be required to proactively report certain foreign
risk communications and actions to Health Canada.
Medical device license holders will
also be required to create and retain summary reports which address
adverse effects, corrective actions, complaints and incidents.
Health Canada s power to
order assessments, studies and tests: Amendments to the
MDR and
Food and Drug Regulations (FDR) clarify the
conditions under which Health Canada can order license holders to
PDF, 962KB, 33 pages).
1. Summary
Part of the MHRA’s role is the regulation of medical devices, including overseeing investigations into adverse events and promoting the safe use of devices in the UK.
The MHRA continues to receive reports of incidents relating to bed rails and associated equipment. These incidents are concerning as some have led to patient harm or death, primarily from entrapment.
This publication has been updated to reflect changes in devices and practices, as well as information gained from the investigation of adverse incidents.
Who this guidance is for:
This document is aimed at all users, carers and staff with responsibility for the provision, prescription, use, maintenance and fitting of bed rails. This includes:
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