Medical Device Apps: An Introduction to Regulatory Affairs for Developers

Area of Science:

• Regulatory Affairs
• Medical Device Development
• European Union Regulations

Background:

• The Poly Implant Prothèse (PIP) scandal led to revised medical device marketing regulations.
• The Medical Device Regulation (MDR) (EU) 2017/745 entered into force May 25, 2017, with mandatory implementation by May 2020.
• Previous Medical Device Directive (MDD) 93/42/EEC has been superseded.

Purpose of the Study:

• To provide an overview of regulatory affairs for manufacturers new to medical device software and apps.
• To focus on the new MDR, harmonized standards, and European Commission guidance.
• To explain the impact of the MDR on software and app manufacturers and patients.

Main Methods:

• Overview of qualification and classification of medical device software and apps under MDR.
• Explanation of conformity assessment routes, technical documentation, and clinical evaluation.
• Description of the role of notified bodies and the unique device identifier (UDI).

Main Results:

• The MDR provides more detailed requirements for software qualification and classification compared to the MDD.
• Rule 11 of the MDR specifically addresses the classification of medical device software.
• The MDR is more stringent, particularly for health apps and software.

Conclusions:

• The MDR introduces significant changes for medical device software and app development and marketing.
• Manufacturers must adhere to stricter regulatory requirements under the new MDR.
• The implementation and interpretation of the MDR will affect all stakeholders in the medical device ecosystem.