What Is EU MDR? The EU MDR Medical device regulation that came into effect in 2021 reformed the process of medical device and drug-device combination products regulation in the EU. In the case of the pharmaceutical industry, it provides more rigorous questioning, more demanding clinical evidence, and more intensive quality control of each of the… Continue reading What Is EU MDR?
Category: Medical devices
International Recognition of Medical Devices | MHRA
Statement of Policy Intent: International Recognition of Medical Devices The UK Medicines and Healthcare products Regulatory Agency (MHRA) aims to facilitate quicker and more efficient access to medical devices by leveraging the expertise and decision-making processes of international regulatory partners. This initiative will benefit patients by allowing the MHRA to recognize approvals from other regulatory… Continue reading International Recognition of Medical Devices | MHRA