Welcome to the clinical toolkit

Following the success of our 2022 Clinical Masterclass Series of webinars, we are delighted to have delivered another successful Masterclass Series of webinars for 2023. We are pleased to share this detailed clinical regulatory toolkit with you, including all on-demand webinars from both 2022 and 2023, as well as whitepapers and guidance documents. We have also written a detailed FAQ document focussing on the key questions asked during the webinar series, which we hope you find useful.

Also, for this year, we have a new Best Practice Guidance document, aimed to guide manufacturers on best practice related to the development of their clinical evaluation documentation under the MDR.  We know that the timeline for ensuring your product maintains EU market access under the new, more stringent Medical Device Regulations (MDR) are challenging. We hope that the information contained in this toolkit will provide you with practical background information to support your application for CE marking.