Devices subject to specific additional procedures
If a device incorporates, as an integral part of its operation, an ancillary medicinal substance or companion diagnostics, the notified body must, as part of the conformity assessment process, request the opinion of a competent pharmaceutical regulatory authority on the device.
The notified body can request an opinion from Fimea in cases where an opinion should not be requested from EMA. The opinion is mandatory and must be considered as part of the certification decision made by the notified body.
Further information about requesting the opinion and about the processing:
Medical devices incorporating a medicinal substance
If a device incorporates, as an integral part, a substance which may be considered to be a medicinal substance, the notified body must, as part of the conformity assessment process, request the opinion of a competent pharmaceutical regulatory authority on the device (Section 5.2 of Annex IX to Regulation (EU) 2017/745). The opinion is mandatory and must be considered as part of the certification decision made by the notified body. The opinion must consider the quality and safety of the medicinal substance, its clinical benefit-risk ratio and its usefulness as part of the medical device.
The notified body must request Fimea’s opinion if an opinion is not requested from the European Medicines Agency (EMA). EMA’s opinion is requested if a marketing authorisation of the medicinal substance has been applied for or must be applied for under the centralised procedure or the medicinal substance is a product derived from human blood or human plasma.
Dossier
- A cover letter, EMA’ application form (pages 6–17 completed), information about the medical device, a declaration signed by a qualified expert and CV, report of the notified body on the benefits of adding the medicinal substance component, and device labels.
- Quality and clinical summary
- The appropriate quality documentation, CEP/ASMF/PMF
- The appropriate preclinical documentation
- The appropriate clinical documentation
The forms and detailed instructions on their content can be found on the EMA website.
Opinion requests must be submitted to Fimea by electronic secure mail (addressed to: [email protected]). The application must be in Finnish, Swedish or English. You must name the application and the annexes clearly.
Fimea’s secure mail
Processing times
The processing time is 210 days. The processing time does not include the time spent by the applicant for responding to requests for further clarifications.
Fee for statements
The fee for statements is based on the current Decree on fees chargeable by the Finnish Medicines Agency
Inquiries related to the consultation process
E-mail: mrp(at)fimea.fi
Please title the query as follows: Question concerning Ancillary Medical Device Consultation.
Companion diagnostics
The notified body must, as part of the conformity assessment process, request the opinion of a competent pharmaceutical regulatory authority on companion diagnostics (Section 5.2 of Annex IX to the IVD Regulation (EU) 2017/746). The opinion is mandatory and must be considered as part of the certification decision made by the notified body. The opinion provides assessment on the suitability of the device in relation to the medicinal product concerned.
The notified body must request Fimea’s opinion if an opinion is not requested from the European Medicines Agency (EMA). The opinion must be requested from the EMA if the marketing authorisation of the medicinal substance has been or must be applied for through a centralised procedure.
Dossier
- Application form (without page 5)
- Draft instructions for use (IFU)
- Draft safety and performance summary
The forms and detailed instructions on their content can be found on the EMA website.
Opinion requests must be submitted to Fimea by electronic secure mail (addressed to: [email protected]). The application must be in Finnish, Swedish or English. You must name the application and the annexes clearly.
Fimea’s secure mail
Processing times
The processing time is 60 (+60) days. The processing time does not include the time spent by the applicant for responding to requests for further clarifications.
The notified body must, in turn, notify Fimea of its final decision.
Fee for statements
The fee for statements is based on the current Decree on fees chargeable by the Finnish Medicines Agency
Inquiries related to the consultation process
E-mail: mrp(at)fimea.fi
Please title the query as follows: Question concerning Companion Diagnostics Consultation.