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New EU Guidance on Device and Diagnostic Sampling
The EU’s Medical Device Coordination Group released a guidance document on requirements for sampling Class II devices for the technical documentation assessments by notified bodies under the Medical Device Regulation and Class B and C devices under the In Vitro Diagnostics Regulation.
The guidance offers details of criteria used for a sampling plans and also clarifies the tasks to be performed by notified bodies.
EU regulations establish 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, but more sampling may be needed to ensure “an adequate coverage of devices on a representative basis,” the group said.
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