Getting Started with Medical Device Regulations

Overview

Medical device regulation is a complex field that ensures the safety and effectiveness of medical devices before they reach patients. This guide provides an introduction to the key regulatory frameworks worldwide.

Key Regulatory Bodies

United States - FDA

The Food and Drug Administration (FDA) regulates medical devices in the United States through:

510(k) Premarket Notification
Premarket Approval (PMA)
De Novo Classification

European Union - MDR

The Medical Device Regulation (EU) 2017/745 governs medical devices in the EU:

CE Marking requirements
Notified Body involvement
Clinical evaluation requirements

United Kingdom - MHRA

The Medicines and Healthcare products Regulatory Agency oversees:

UKCA marking (post-Brexit)
MHRA registration requirements

Device Classification

Medical devices are classified based on risk:

Class I: Low risk (e.g., bandages, stethoscopes)
Class II: Medium risk (e.g., X-ray machines, infusion pumps)
Class III: High risk (e.g., heart valves, implantable devices)

Key Requirements

Quality Management System

ISO 13485 compliance
Design controls
Risk management (ISO 14971)

Clinical Evidence

Clinical evaluation
Post-market clinical follow-up
Literature review

Labeling and Documentation

Instructions for use
Risk-benefit analysis
Technical documentation

Next Steps

Determine your device classification
Identify applicable regulatory pathways
Develop quality management system
Prepare technical documentation
Conduct clinical evaluation
Submit regulatory application

Resources

FDA Guidance Documents
EU MDR Official Text
ISO Standards (13485, 14971)
Regulatory consultants