Commercializing your medical device first requires you to obtain registration and approval from regulatory agencies in each country where you plan to sell your device.
This webinar provides an overview of manufacturer responsibilities for clinical evaluation under the MDR. The scrutiny of clinical evaluations by Notified Bodies has increased with the EU Medical Devices Regulation 2017/745 (MDR).
Watch this webinar to learn the anticipated updates to the EU IVDR 2017/746 and EU MDR 2017/745, what to look out for from the UK Medicines and Healthcare Products Regulatory Agency (MHRA) and the next steps for Switzerland.
Review recently released and expected guidance documents from the US FDA, the growing use of real-world evidence and regulatory science tools in submissions, and expectations for 2022 and beyond.
This webinar explains the Performance Evaluation concept introduced by IVDR 2017/746 and focuses on the interaction of elements required for manufacturers to perform an adequate Performance Evaluation.