Prepare for change
in 3 steps

MEDICAL DEVICE REGULATION

IDENTIFY THE CLASS OF YOUR MEDICAL DEVICE

Start by defining the intended use of your software, so you can learn which standards it needs to comply with. This will help you to identify your software’s class too. As part of the MDR coming into force in a few months, almost all software-driven medical devices or apps will be up-classified into Class IIa or Class III. Read Rule 11 of the MDR for more information.

DIVE DEEP INTO THE MDR

The only way to fully understand MDR is to study it inside-out! Make sure to take notes on where it will impact you. Reading our guidebook “Medical Devices Regulation 2020 - Everything You Need to Know” is a good starting point: it summarises what will change and what will stay the same.

CREATE A COMPREHENSIVE PLAN

This will be a major task; one that, again, our guide can help you prepare for. Start by compiling a list of tasks, and don’t forget to include a timeline and to map out resource allocation. To give you a head start, here are a few examples of the must-dos:
• Put in place a quality management system
• Assign a team responsible for ensuring compliance with the new regulation
• Create a risk management system
• Define a process for your software’s clinical evaluation
• Establish a post-market surveillance plan

WHITE PAPER

Medical Device Regulation 2020:
Everything You Need to Know

WHITE PAPER

The Role of Software in
Medical Device Failures

WHITE PAPER

Automated Verification & Validation
for Medical Devices