Making medical devices safe
We will all need to use medical devices at some point in our lives – if we don’t already use them. The term ‘medical device’ is broader than you might think – covering everything from a contact lens to a pacemaker and the software that monitors its performance. We expect that these devices will be of high quality and will perform their intended service. However this does not just happen – legislation is needed to ensure the safety of the medical devices we use.
New EU legislation governing the manufacture, sale and use of medical devices on the EU market entered into force in May 2017. The new Medical Devices Regulation (MDR) and In vitro Diagnostic Medical Devices Regulation (IVDR) bring legislation up to date with advances in medical technology, improve safety and iron out inconsistencies in the interpretation of the existing rules across the EU.
They also bring with them a number of new responsibilities for stakeholders all along the medical devices value chain. GOPA Com. supported the European Commission in keeping these stakeholders informed of their roles and responsibilities under the new Regulations and in helping them to prepare in time for their application. This has been particularly important over the past year, when the resources of the entire medical value chain have been stretched as never before, dealing with the impacts of the Coronavirus pandemic.