Medical Device Regulations Database

Swiss Database on Medical Devices

Swiss medical device database. Voluntary registration from August 2025; mandatory registration from July 1, 2026. Transition period until December 31, 2026.

European Database on Medical Devices

EU central database for medical device registration, UDI, certificates, and vigilance. First four modules mandatory from May 28, 2026. Decision 2025/2371 declared EUDAMED functionality.

FAQ on MDR/IVDR and Artificial Intelligence Act

FAQ on interplay between MDR/IVDR and the EU Artificial Intelligence Act. Addresses AI-enabled medical devices and dual compliance requirements.

Reduced Shelf Life Requirements for Imported Devices

Reduces minimum shelf life required for imported medical devices from one year to six months. Replaces Disposición 1655/1999.

Terminologies for Categorized Adverse Event Reporting (AER)

Standardized terminologies, terms, and codes for categorized adverse event reporting. Enables harmonized global vigilance data exchange.

Medical Device Regulation - Consolidated Version 2025

Consolidated version of EU MDR including all amendments through January 2025. Includes extended transition periods, Article 120 amendments, and supply chain notification requirements (§10a).

In Vitro Diagnostic Regulation - Consolidated Version 2025

Consolidated version of EU IVDR including all amendments through January 2025. Class D devices transition by May 26, 2025; Class C by May 26, 2026.

Medical Device Sanitary Control and Import Procedures

Requirements for import licenses, customs clearance, and regulatory compliance for medical devices imported into Brazil.

DGDA Quality Assurance Guideline for Medical Products (PDF)

DGDA guideline for quality assurance of locally sourced medical products. Defines marketing authorization requirements and quality standards.

Guidance on Breakthrough Devices (BtX)

Guidance on Breakthrough Devices under MDR 2017/745 and IVDR 2017/746. Addresses expedited assessment pathways for innovative devices.