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 Regulation 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. 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.
Performance Evaluations under the IVDR is a big problem for the IVDR. This procedure is characterised as a continuous process that aims to give enough clinical evidence to show that the device will offer the expected clinical benefits and is safe. We as consultants support manufactures with has created templates and guide you through the process.
To be placed on the European market after May 26, 2022, all devices must fulfil the IVDR’s standards. Under certain situations and provided the maker meets the precise precondition requirements written forth in the IVDR (Article 110 (3)), products already approved by a Notified Body may be placed on the market until May 25, 2024.