In this recorded webinar, Ronald Boumans, a Senior Regulatory Consultant at Emergo’s office in The Hague, examines the potential impact of a no-deal Brexit and how manufacturers, patients, and healthcare providers can prepare.
Within the next few years, the regulatory landscape will change dramatically for IVD companies selling in Europe. IVDR 2017/745 will be an entirely new classification scheme for IVDS, and places far more emphasis on clinical data and risk management
Are you planning to export your device to other medical device markets? Most countries require you to have a physical presence in that market. If you do not have an office there, you can appoint an independent representative to meet this need.
Europe's new Medical Devices Regulation (MDR) adds to the complexity of complying with specific PMS and post-market clinical follow-up (PMCF) requirements. In this free webinar, we discuss new European PMS and PMCF requirements.