The workshop will feature presentations on the key legislative requirements, existing work in technical committees and a discussion on how we could potentially generate an approach to integrate the requirements for PPE, medical products, and dual use products. Therefore, we hope to bring together stakeholders from different perspectives.
During the COVID-19 crisis there was (and still is) a lot of confusion about the legal status and the intended/claimed purpose of equipment to be used by the healthcare sector or to protect against the virus. It is not always clear for the users if a product is a PPE product, a MD product, a combination of both or none of those. The fact that in many communications ‘protective equipment’ is used to refer to both types of products is only contributing to the confusion. Furthermore, some of PPE that are not related to the current health crisis should be considered as dual use product, MD as well as PPE.
To create clarity and to avoid this confusion, a harmonised approach in the single market should be considered for those products. In this workshop, we would like to create a first step towards a common understanding of the opportunities and challenges to create this integrated approach.
Attendees will be invited to discuss and share their views and experiences that will enable CEN and CENELEC to make an informed decision on the possibility of standards in this area.
