Fimea's Medical Devices Advisory Clinic to provide tailored assistance on how to meet official requirements

With the entry into force of the MD and IVD Regulations, the clinical evidence requirements for medical devices have become more stringent, and permits for research using medical devices apply to an increasing number of studies. Determining official requirements well in advance during a clinical trial’s planning stage speeds up the permit process of the study and makes it easier to carry out the study. 

Fimea's Medical Devices Unit will launch the Medical Device Advisory Clinic in early April to support researchers.

The support provided by Fimea aims to promote both academic and business innovation activities in the field of medical devices. Fimea wants to support and assist researchers already at the planning stage of their study if researchers are unsure about the official requirements related to their study. Apply for assistance from the Medical Device Advisory Clinic with a written request, and Fimea will assess the need for advice and its scope on a case-by-case basis. 

The aim of the advisory services is to find answers to specific questions posed by the customer, such as those that apply to research design or documents required in official processing. The advice given will not be binding on Fimea or the body requesting advice. Fimea also does not issue preliminary decisions. Services provided by the Medical Device Advisory Clinic are free of charge. 

Applications for a Medical Device Advisory Clinic and other contact with the clinic via e-mail to [email protected].

For more information, see the Fimea website.