Medical devices save lives. The sooner you can get your medical device out to the market, the sooner it can help people. But before you can do that, you need [ … ]
Month: August 2021
European Medical Device Importers and Distributors Have New Regulatory Responsibilities Under EU MDR Articles 13 and 14
When the European Medical Device Regulation (2017/745) was published in 2017, few medical device importers and distributors were aware of the new requirements that would be placed on them. The [ … ]
Medical Devices Regulation (EU) 2017/745 – MDR
On 5 May 2017, two new Regulations on medical devices were published, and they entered into force on 25th May 2017. The Medical Devices Regulation (MDR) date of application is [ … ]