The following Life Sciences practice note produced in partnership with Alison Dennis of Taylor Wessing LLP provides comprehensive and up to date legal information covering:
Post-market surveillance is the monitoring by manufacturers of medical devices to ensure their health and safety for patient use at the later stage after approval once distributed on the market. Its purpose is to identify if any necessary corrective or preventive safety measures are required. Although the medical device directives regulatory regime set out compliance requirements, it has received criticism that it was not stringent enough in monitoring safety once devices are actually put into use by patients to feedback into the official device safety profile and its authorisation.
A key focus of the regulatory overhaul for medical devices in Europe is the increase in post-market surveillance obligations. In particular, there is an emphasis on the collection of clinical and safety-related data after receiving CE certification and market access to avoid hidden defects or security threats.
Devices must be monitored to detect risks that may only become apparent once used, transported, stored or cleaned. This requires stakeholders involved in the supply chain of devices to implement robust interrelated systems and maintain a significant paper trail.
This Practice Note examines the changes to the EU regulatory regime introduced by Regulation (EU) 2017/745, the Medical Devices Regulation (MDR) and Regulation (EU) 2017/746, the In Vitro Diagnostic Medical Devices Regulation (IVDR), collectively referred to as the ‘MD Regulations’, in relation to its
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