A quick introduction to medical device law

This page is aimed at anyone who needs a quick introduction to the world of medical device law and quality management, for example, because they want to get their devices approved.

1. A quick introduction for beginners

a) An initial overview

The article “In 7 steps to a medical device” provides you with a very quick introduction to the topic of “approval of medical devices” (in Europe).

On this page, you will find a presentation that you can look through in just a few minutes, as well as a detailed description of the seven steps.

b) The starter kit

The free starter kit contains

• an e-book explaining the regulatory framework,
• checklists that you can use to check the conformity of your devices,
• an overview of all relevant standards and laws.

You can download the starter kit here.

2. Topics you need to be informed about

a) Regulatory framework

The “regulatory affairs” page helps you get started and provides an overview of standards and laws. If you are based in Germany, you should be familiar with German laws and regulations. If you are based in the USA, you should be familiar with the FDA requirements.

You should understand

• When your device counts as a medical device and which class it falls into (qualification and classification).
• What special features there are for class I devices
• Which documents a technical documentation consists of
• Which general safety and performance requirements it must demonstrate
• What role harmonized standards play here
• How audits work

b) Important activities

Beginners should also familiarize themselves with these activities at a very early stage:

• Precisely determining the intended purpose for their devices
• Defining the risk acceptance criteria for them
• Verifying and validating the devices
• Preparing the clinical evaluation
• Selecting the appropriate conformity assessment procedure and issuing a declaration of conformity
• Establishing a QM system, creating a QM manual for it, and defining processes and procedures
• Building a successful development team

3. Further tips for beginners

Under the keywords medical equipment, standalone software, medical apps, medical software, DiGA, and IVD, you will find tips on the individual product categories.

A glossary provides an overview of many terms.

Another article explains to newcomers what causes medical start-ups to fail and how they can avoid this.