The EU has postponed the date of application for the Medical Device Regulation by a year due to the COVID-19 pandemic, meaning that it will now take effect from May 2021. The extension to the transition period gives you a few extra months to focus on the topic of Software as a Medical Device (SaMD) and to update your processes and documentation in line with the new regulations.
As an operator, you must maintain an inventory of active medical devices; arrange for active, non-implantable medical devices to undergo regular safety testing (Articles 6 and 9 of the Austrian Medical Device Operator Ordinance – MPBV) and ensure the compatibility (Article 2(25) Medical Device Regulation – MDR) of your medical device software. Before you can effectively do this, you need to know about the medical device software that you are using.
Step 1: Find out which software is being used, which is classed as a medical device and which is compatible.
x-tention will help you ensure that your IT and software landscape get a clean bill of health with the Medical Software Compliance Check. Benefit from our extensive knowledge about regulatory requirements around SaMD. We will hold joint workshops that will clarify which articles in the MDR and MPBV are relevant to you as an operator. Use our templates to record the details of your medical device software, and then let x-tention handle the time-consuming and resource-intensive task of researching the exact manufacturer information. We will use practical examples to train you in how to check the compatibility of your medical device software.
Step 2: Be safe, stay safe
As a cooperation partner of TÜV Austria, x-tention is qualified and authorized to perform regular safety checks for your SaMD. We use predefined checklists to ensure that your medical device software is safe for patients to use. TÜV Austria issues a test report as proof and as confirmation of its safety.
Don’t let regulatory complexity put you off, start tackling it now with support from x-tention!
