Use the tags to quickly find relevant articles. Click on the respective tag (shown below as links). This will take you to a brief introduction to the topic and, below that, to all the corresponding articles.

Legal areas, regulations, authorities

Most articles provide advice that is helpful in all legal areas. However, if you are looking for information that is specifically relevant to a legal area, a regulation, or an authority, then use these keywords:

• FDA
• International approval
• German laws and regulations
• Medical Device Regulation MDR (2017/745)
• Medical Device Directive 93/42/EWG (MDD)
• Notified bodies
• BfArM

Roles

Select the articles according to your role:

• Beginners who are new to the subject
• Management and executives (managing directors, vice presidents, CxOs, …)
• Hospitals, laboratories, practices, and other operators

Product type

The following tags filter the articles according to product type:

• In-vitro diagnostic medical devices (IVD)
• Medical technology – medical equipment – active medical devices

There are additional tags for devices that contain software or are software:

• Medical software
• Clinical information systems
• Standalone software
• Mobile medical apps
• Digital health applications (DiGA)

Regulatory cross-cutting topics

The following tags are largely independent of the legal area and product types:

• Qualification and classification
• Requirements, stakeholder requirements, system requirements
• General Safety and Performance Requirements (GSPR)
• Technical documentation for medical devices
• Clinical evaluation
• Validation
• Conformity assessment procedures and audit
• Processes and procedures
• Post-market phase

Specialist topics

Other topics

At the meta-level, it is important to adapt your organization continuously to meet regulatory requirements and remain competitive. This is because the environment (e.g., competitors, technologies) constantly changes.

Please refer to the articles on the keyword (tag) transformation projects.