COCIR* issued today an easy-to-use tool to help determine whether software is a medical device or not.
Since the revision of the European Medical Device Directive, in force as of 21 March 2010, the definition for medical devices also includes software used for diagnostic and therapeutic purposes. In December 2009, the European Commission decided to develop a European guidance document to clarify which standalone software is a medical device in its own right.

However, European Member States still interpret current regulation inconsistently, which results in unfair competition and different levels of regulatory control affecting patients, users and COCIR’s industry members.

The COCIR decision tree together with the explanatory text and examples may help to solve this situation. COCIR has designed this simple tool to determine whether software is to be considered as a medical device in the European regulatory framework. The COCIR decision tree has been developed based on discussions with various stakeholders. It is offered to the European Commission for inclusion in the future European guidance document on Qualification and Classification of Medical Software.

Koen Cobbaert, COCIR Medical Software Task Force Chair stated “With the COCIR decision tree, you can easily find out whether a software application is considered as a medical device and thus must be CE-marked. We are anxiously awaiting European guidance as we see different approaches among regulators.”

Nicole Denjoy, COCIR Secretary General, who presented the COCIR tool to the Steering Committee of the Global Harmonisation Task Force (GHTF) in November and said ”This decision tree could be a step forward to global convergence of regulation of medical software.”

COCIR is freely sharing this concept and is seeking international acceptance. Comments and suggestions on the COCIR decision tree are welcome and can be sent to Olivier Deneve at deneve@cocir.org.
 
 

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