The first EIPG Webinar of 2021 will be held in conjunction with PIER and University College Cork on Wednesday 3rd February. It is entitled: “The Practical Implementation of EU Regulations for Medical Devices and in vitro Diagnostic Medical Devices”.
Regulation 2017/745 on Medical Devices (MDR) and Regulation 2017/746 on In-Vitro Diagnostic Devices (IVDR) were agreed at a political level between the three relevant European institutions (European Council, European Parliament and European Commission) and entered into force in May 2017. The Regulations have a staggered transitional period with some aspects becoming legally binding after 6 months of entry into force. The MDR was due to become fully applicable on 26 May 2020 after a three-year transition period. However, due to the global outbreak of Covid-19, full application of the MDR has been postponed and will become fully applicable on 26 May 2021. The IVDR will be fully applicable on 26 May 2022, after a five-year transition period.
The speaker is John Deavin, a pharmacist and Qualified Person who has been responsible for the registration of a large range of medical devices during his career in Regulatory Affairs.
Compliance with the general safety and performance requirements for labelling, technical documentation and quality management systems for medical devices will be some of the subjects discussed. The importance of clinical evaluation, classification of devices and the roles of the Competent Authorities, the European Commission, the Medical Device Coordination Group, Notified Bodies and EUDAMED will be explained.
See attached flyer for registration details EIPG MDR IVDR webinar_3rd Feb 2021. Please be aware that you will receive connection details for the webinar when you register and will need to keep the Zoom meeting details to join the webinar.