Compassionate use cases for Medical Devices

Compassionate use cases are a concept under EU Regulation (EU) 2017/745. The legal basis is Article 59(1) MDR in conjunction with § 7(1) MPDG.

With this, the legislation provides the possibility, in emergency or exceptional cases, such as for the purpose of a compassionate use, to bring medical devices to the market or approve them without the complete, regular conformity assessment procedure, if this is in the interest of patient health, patient safety, or public health.

We have been familiar with compassionate use procedures for over 10 years and are happy to support you with our experience, assist in preparing an application, and submit it to the Federal Authority on your behalf.

 

Requirements

A Special Authority Approval can be applied for or granted, 

if i.e. there is a clinical indication and need for a Compassionate Use (an individual therapeutic attempt) and an urgent medical necessity for the application of a product that is not available on the market or CE-certified or is intended to be used outside its intended purpose.

 

Note: A special approval for compassionate use represents a temporary exception and does not replace regular CE certification nor is it a recertification. The user bears responsibility.

 

Please feel free to contact use for detailed information.