Medical Devices (includes In Vitro Diagnostics)
The implementation of Medical Device Regulation (MDR) requirements brings a multitude of challenges for manufacturers, and in some cases what appear at face value to be small additional requirements can become substantial activities. The requirement of GSPR 10.4.1 is that, based on the criteria of body contact, (re)administration or transport/storage of medicines, fluids or substances, such devices shall only contain certain substances in a concentration of greater than 0.1% W/W with appropriate justification and labelling. These substances are those which are deemed carcinogenic, mutagenic or toxic to reproduction (CMR) or have endocrine-disrupting (ED) properties.
Whilst the assessment must be sufficiently robust, manufacturers need to be cautious in creating a process that becomes unnecessarily complex and burdensome. This session will discuss a 3 stage process of review of CMR and ED agents, the challenges in obtaining relevant information, and provide practical tips to ensure a pragmatic approach acceptable to all stakeholders is provided. Integration of the process within the manufacturer's Quality Management System will be considered, as well as discussing the links between good design inputs, risk management, biocompatibility and supplier controls. Practical steps to provide pragmatic approaches for both legacy and new devices will be provided.