Registering a Medical Device with Competent Authorities
Let's consider a hypothetical medical device manufacturer based in Germany that produces an innovative infusion pump system intended for use in hospitals and healthcare facilities across the European Union.
Preparation of Technical Documentation:
The manufacturer prepares all necessary technical documentation for the infusion pump system, including design specifications, risk assessments, clinical evaluation reports, labeling, and instructions for use. This documentation is prepared in accordance with the requirements of the Medical Device Regulation (MDR).
Obtaining CE Marking:
The manufacturer ensures that the infusion pump system meets all applicable requirements of the MDR and undergoes the necessary conformity assessment procedures. Upon successful completion of the assessment, the manufacturer affixes the CE marking to the product, indicating its compliance with EU regulations.
Engaging a Notified Body (if applicable):
Depending on the classification of the infusion pump system and the conformity assessment route chosen by the manufacturer, involvement of a notified body may be required. The manufacturer engages a notified body accredited for the assessment of medical devices to conduct conformity assessment procedures, such as assessment of design documentation and quality management system audits.
Registering with Competent Authorities:
The manufacturer registers the infusion pump system with the national competent authorities of the European Union member states where they intend to market the device. In this example, the manufacturer registers the device with the German competent authority, the Federal Institute for Drugs and Medical Devices (BfArM), as well as with other relevant competent authorities in EU member states where they plan to market the device.
The registration process typically involves submitting the required documentation and information to the competent authorities, including details about the device, its intended purpose, manufacturing facilities, quality management system, and clinical evidence supporting its safety and performance.
Upon successful registration, the competent authorities issue registration numbers or certificates, which may be required for marketing the device in the respective member states.
Post-Market Surveillance:
The manufacturer establishes procedures for post-market surveillance to monitor the performance and safety of the infusion pump system once it is placed on the market. This includes monitoring adverse events, conducting field safety corrective actions (FSCA) if necessary, and submitting periodic safety update reports (PSUR) to the competent authorities.
