The global response to the new Coronavirus (COVID-19) has led to many European companies wanting to support the development of medical technologies. In this exceptional situation, the MHRA decided to authorise exemptions for certain Personal Protective Equipment and set out a‘minimally acceptable’ performance for ventilators. However, many new ideas for medical devices that can provide solutions in this crisis do still need to follow the full EU medical device regulations. Unfortunately, the need for support on this has drastically increased, without any increase in available resources.
Oxford has developed an online tool (www.OxfordGlobalGuidance.com) for researchers, companies and innovators to check if they are working on a medical device and if so it provides the anticipated risk classification according to the regulations.
This tool can support the those (relative) new to the field of medical devices to better understand what it is they are developing and which rules apply to them. The tool has been officially launched today in light of the surge of groups that are trying to develop “new” technologies. The tool has been reviewed and tested for more than a year.