The EU’s Medical Device Coordination Group issued new guidance on requirements for sampling Class II devices for the technical documentation assessments by notified bodies under the Medical Device Regulation (MDR) and Class B and C devices under the In Vitro Diagnostics Regulation (IVDR).
The guidance offers details of criteria used for sampling plans and also clarifies the tasks to be performed by notified bodies.
The MDR and IVDR include minimum requirements for sampling prior to issuing a certificate. The notified body must ensure that the requirements are met when drawing up a sampling plan. In addition, other considerations have to be observed in order to ensure “an adequate coverage of devices on a representative basis,” the group said.