COCIR supports economic operators under the Medical Device Regulation

New Template for Suspected Incident Form for Trade Partners

The obligations of the different economic operators are laid down explicitly for the first time in the newly adopted Medical Device Regulation (MDR) 2017/745 and In-Vitro Medical Device Regulation (IVDR) 2017/746 (read the dedicated COCIR position paper here ). One of these changes means that importers and distributors are now required to notify immediately the manufacturer and the Authorised Representative (MDR Articles 13 (8) and 14 (4 & 5)) about all complaints and reports about suspected incidents that they become aware of.

The EU MDR ‘incident’ definition (MDR Article 2 (64)) is broad as it includes any malfunction, deterioration in the characteristics or performance, use error, undesirable side-effect and inadequacy in the information provided by the manufacturer. COCIR members’ complex devices (“big capital” equipment) require servicing activities during their lifetime that can be long (10 or 15 years is not unusual). Most users’ calls are about corrective maintenance requests that are related to suspected malfunction or deterioration of the performance and, consequently, are in the scope of the ‘incident’ definition.

To facilitate this information flow, COCIR members have agreed on a common template for a Trade Partner Suspected Incident Form. Distributors and importers can use this form to notify manufacturers about any suspected incidents that they become aware of. The form will also support manufacturers when fulfilling their obligations, as the received information can be more easily structured and analysed.