Fimea published a clinical investigation plan template to support clinical investigations of medical devices

Fimea has published a clinical investigation plan (CIP) template designed to support investigators and organisations conducting clinical investigations of medical devices.  The CIP template helps to ensure that investigations meet the essential requirements of both the EU Medical Devices Regulation (MDR 2017/745) and national legislation.

What are the benefits of the template? 

Planning a clinical investigations of medical devices is a demanding process consisting of multiple stages, and meeting the regulatory requirements can be challenging. The new template provides a clear structure and guidance enabling  the CIP to be prepared more efficiently and in accordance with the applicable requirements. 

Who is the template intended for?

The template has been developed specifically to address the needs of start-ups and academic researchers, for whom resources may be limited and interpreting the regulatory requirements may be time-consuming.

With the help of the template:
•    The quality of the investigation plan will improve
•    Application preparation may proceed more quickly
•    Administrative work will be reduced

Benefits to the person conducting the clinical investigation:
•    Clear structure: all the required sections in one document
•    Regulatory conformity: Requirements of both the MDR and relevant national legislation have been taken into account 

Where is the template available?

The CIP template is available on Fimea’s website. Introducing it into use is voluntary, but highly recommended – try the predesigned structure and use it to support your research!
Finnish and Swedish versions of the template are also available for those who need them.
 

Read more:

Investigations with medical devices