Effect of the Medical Device Regulatory Changes on Digital Solution Development and Healthcare Industry in the European Union

Description

The rapid technological advancement changes the healthcare industry: new digital solutions enter the market every day. Thus the regulation becomes particularly important to ensure patient safety, and it shall adjust to be relevant and adequate.The EU regulation framework had been questioned previously and after experiencing various scandals, a new regulation has been introduced with more detailed requirements (EU 2017/745). However, due to the complexity of the new regulation there are various implications on software-as-a-medical-device (SAMD) development, and the objective was to identify the hindering factors. . A systematical literature review was conducted to identify how the regulation impacts various aspects of development, launch and marketing SAMD while being compliant to the MDR 2017/745. Then the identified hindering factors were consolidated into dimensions.. The identified hindering factors were consolidated into 8 dimensions and their consequences were explored. It shows that currently Europe has lost its attractiveness and many manufacturers are actually reconsidering their business strategy in the light of the complex legal framework and requirements. Some manufacturers are discontinuing providing devices at all, others are leaving the EU market. Yet the rest of the devices in EU are expected to become more expensive and less available, thus eventually jeopardizing the overarching goal of patient safety, and undermining the efforts to increase high quality healthcare availability. . While the new MDR promised increased patient safety and regulatory oversight, the changes are already altering the medical device market. The manufacturers shall review their strategy, while policy-makers shall pay attention to the emerging problems in the industry and develop tools to support manufacturers. 

Period	29 Mar 2023
Event title	RSU Research week 2023: PLACES
Event type	Conference
Conference number	3
Organiser	Rīga Stradiņš University
Location	Rīga, LatviaShow on map
Degree of Recognition	International