New Regulation Enhances Medical Device Safety Reporting

New Regulation Overview

A new regulation, 1/2023, issued by the Medical Safety and Development Center Fimea on May 16th, 2023, aims to improve the reporting process for medical devices by professional users and provide instructions for handling devices involved in risky incidents.

Effective from November 1st, 2023, the regulation supplements Section 33 of the Medical Devices Act, ensuring that emergency notifications contain comprehensive and uniform information crucial for managing those types of situations and identifying root causes. It aligns hazard classification with manufacturers' classifications and introduces protocols for handling devices in dangerous situations.

This regulation underscores a commitment to enhancing medical device safety and efficacy. It has an impact on:

Improving the reporting process
Enhancing patient safety
Providing consistency and coherence
Manufacturer accountability
Regulatory compliance

Manufacturers, healthcare professionals, and regulatory bodies should familiarize themselves with the requirements to ensure compliance and contribute to advancing device safety.

This regulation represents a significant step in strengthening emergency notification processes and reinforcing safety measures within the evolving healthcare landscape.