IVDR Regulation (2017/746)
We, as a regulatory affairs consultant support small, medium and large manufactures across the globe covering the below devices for EU IVDR and UKCA Certification:
Monitors for blood glucose
Assays on clinical chemistry
PCR assays including next generation sequencing panels
Self-tests and near-patient testing devices
Blood grouping devices Infectious agents are detected Devices
Human genetic testing equipment
Self-testing devices fall under the special IVD group. The manufacturers want to use these IVDs in a home setting, such as pregnancy testing, for laypeople.
Performances assessment devices to be used outside the manufacturer’s facility in performance appraisal studies must also comply with the applicable Directive specifications.
The IVDR shall not apply to products used exclusively for veterinary use or to products used in general laboratories. Invasive sampling equipment undergoes MDR (Medical Devices).
The EU IVDR is approaching. Are you prepared for the date of May 2022?
IVDR CE Certification
About 20% of IVDs require Notified Body intervention to obtain the IVDR CE Certification, but after EU IVDR is implemented, more than 80% of IVDs require Notified Body scrutiny to obtain the CE Certification. It ensures that suppliers must update their files to meet EU IVDR standards.