FIMEA Authorizes GlucoModicum to Conduct Pre-Pivotal Clinical Investigation Under EU MDR Article 62

Finland’s medicines agency, FIMEA, has authorized GlucoModicum to initiate a pre-pivotal clinical investigation of the Sofio needle-free glucose monitor under Article 62 of the EU Medical Device Regulation (EU MDR 2017/745). This authorization enables GlucoModicum to optimise the performance of Sofio prior to entering pivotal clinical investigation required for CE marking and subsequent market entry.

Article 62 defines the regulatory framework for clinical investigations intended to support conformity assessment. It sets the standards for ethical oversight, participant protection, study design, and data quality, ensuring that clinical evidence is generated in a controlled and compliant manner.

This approval marks an important procedural step in GlucoModicum’s regulatory pathway, supporting the transition toward pivotal studies and formal assessment under the MDR.