New regulations, which were adopted on 2017年5月26日, will affect all device and diagnostics manufacturers looking to sell products in the EU, with stricter requirements being introduced in order for these products to be approved.
Here we provide some essential information about the new Medical Device and In vitro Diagnostic Regulations, and what they mean for those involved in medical devices and diagnostic development.
On 2016年6月27日, the final drafts of the Medical Device Regulations (MDR) and In-vitro Medical Device Regulations (IVDR) were made public and entered into force on 2017年5月26日.
The transition period will be three years for the MDR and five years for the IVDR, meaning that the dates of application (DOA) will be 2020年5月26日 and 2022年5月26日, respectively.
However, this does not mean that there are three (or five) years to prepare for this. There are some major changes, so it is essential for medical devices manufacturers to engage management in the process now, so that money and resources can be available to support and implement the new device regulations.
