Fimea develops services starting from the medical device operator and device register
Fimea’s tasks include gathering information on a large scale about the pharmaceutical sector and medical devices, and processing of licences and notifications. We are developing our services to ensure more efficient operations and improve customer satisfaction. The reform of Fimea’s e-services begins with the CERE register for medical device operators and devices.
In January 2020, the responsibility for the supervision of medical devices and development of the CERE register was transferred from Valvira to Fimea. The reform project of the actual register was started before this transfer and lasted for several years. The new CERE register, which complies with the requirements of the EU Regulations, was taken to use in May 2021. After the register reform, the aim was to streamline services offered to customer groups and submitting notifications. Medical device operators were selected as the first customer group whose e-services we began to develop.
Medical device operators submit a notification of their operations and devices to the national CERE register and the Eudamed register maintained by the European Commission before selling medical devices, placing them on the market or making them available on the market. Annually, approximately 177 initial registrations and more than 4,000 device notifications are submitted to CERE.
The project began in April 2022. New e-services have been implemented rapidly by an expert team consisting of the medical device unit and the information management unit. Our partner in the development of e-services is Solita. The key objectives of the e-service reform are improved customer experience, implementation of new legal requirements, faster processing times of notifications and higher quality of information.
The project develops a browser-based service using the strong identification and authentication service offered by the Suomi.fi service. In the first version of the e-service, representatives of a company or organisation can submit notifications and review previous notifications. The e-service can also be used on mobile devices.
After publication of the first version, the e-service will be developed further by adding the possibility to check and add invoicing details to achieve an e-service process that is as automatic as possible. Parallel to CERE services, Fimea’s financial services unit develops services linked to the invoice information system. When completed, invoice information will be linked to all services involving fees.
The new service for medical device operators will be published in the spring of 2023. We will inform customers on the “Medical devices” page when the e-service becomes available.
In terms of volume, one of the most important notification types is incident reports related to medical devices. The most important source of incident reports are health care operators’ own systems from where incident reports made by professional users are sent directly to Fimea. Their annual number exceeds 1,000. That is why, instead of e-services, the most important goal is to offer a modern interface for forwarding reports from health care systems. In connection with the e-service project, the CERE project is also building modern interface technology.
The outputs of the CERE e-service project also benefit and speed up the reform of other services offered by Fimea. The next step is to reform services for submitting notifications of supply failures and drug adverse reactions. The developed interface will also be used for Fimea’s future interface-based services.
Medical devices (www.fimea.fi)