Description: One of the aims of the Medical Device Regulation (MDR) is to ensure that the regulatory framework considers technological advancements, as well as the safety of legacy devices that have been on the market under the Medical Device Directive (MDD). ‘Nanomaterial’ is now defined in the MDR, and manufacturers are required to give particulate nanomaterials “special attention” under General Safety and Performance Requirement (GSPR) 10.6. The presence of nanomaterials will affect a device’s classification dependent on the potential for internal exposure; this could result in devices being up-classified under the MDR. The MDR also requires manufacturers to pay “particular attention.. to… surface properties”. Manufacturers should expect additional Notified Body scrutiny for such devices, including those that generate nanomaterials and release them into the body, as well as those with nanostructured surfaces). ISO/TR 10993-22:2017 provides a general framework highlighting important aspects that need to be considered when assessing the safety of such medical devices. This document describes the state of the art of nanomaterials; it does not contain detailed testing protocols, but rather identifies several common pitfalls and obstacles which have been identified when testing nanomaterials compared to bulk materials or small molecule chemical species. Moreover, the terms and definitions within ISO/TR 10993-22:2017 are not the same as those in the MDR. The session will examine the overlap and difference between the MDR and ISO/TR 10993-22:2017, and how manufacturers should utilise the biological considerations discussed within the Technical Report in order to support MDR compliance in this area. Finally, the session will look at how manufacturers should use the risk assessment framework described in ISO 10993-1:2018, and the guidance within the 2015 report from the EU Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR), to manage their nanomaterial MDR compliance strategy.
Learning Objectives:
Upon completion, participants will be able to demonstrate their understanding of the requirements regarding nanomaterials within the MDR, and the state of the art described in ISO/TR 10993-22:2017.
Upon completion, participants will be able to start developing MDR nanomaterial compliance strategies, aware of the value ISO/TR 10993-22:2017 might bring, but the challenges that remain.
Upon completion, participants will also understand the role ISO 10993-1:2018 plays in supporting their MDR submission where nanomaterials are concerned.