IVD regulatory approval process in European Union.
Approaches to the regulation of in vitro diagnostic (IVD) medical devices vary by country. For example, in the United States, there is no separate classification for IVD devices, and a general regulatory system developed for medical devices is applied. If we talk about the European Union (EU), then the approach is different. For IVD products, a separate classification and a separate “main” legislative act have been developed – EU Regulation 2017/746.
It is important to note that a new version of this regulation has recently been released. The content of this document is the same as before, but some key dates (for example, the effective date of certain requirements for HIV and hepatitis tests) have been changed.
As in Russia and the USA, the registration of a medical device in the EU is largely determined by belonging to a certain class. In the EU, IVD products are divided into 4 classes: A, B, C, D. The classification is based on the intended use and risk class of the device (Article 47).
For devices of all classes, it is necessary to implement a quality management system that complies with Annex IX IVDR. Most companies use the ISO 13485 standard for this.
Further, for devices of all classes, a technical document is developed that reflects the compliance of the IVD with the requirements of Annexes II and III of the IVDR. In addition, registration in the EU requires an authorized representative (EU REP) with the appropriate qualification to carry out regulatory activities located in Europe. The data about EU REP (name and address) must be indicated on the instructions for medical use and packaging when selling products in the EU countries.
Also, for devices of all classes, it is necessary to register the manufacturer and IVD product in the EUDAMED database. The result is a unique product identification number (UDI).
Then for devices of classes B, C, D, an audit is carried out by a notified body in Europe. Based on the results of the audit, in case of a positive result, a CE marking is issued. Class A products do not pass this stage.
The manufacturer then prepares a Declaration of Conformity stating that the IVD product complies with the requirements of the IVDR (applicable to all product classes). The device can then be CE marked.
After that, class A devices can be sold, while the CE certificate is issued indefinitely. For other product classes, the notified body will have to carry out audits every 6-12 months to ensure compliance with the requirements of Annex 98/79/EC.
For class D devices, it is also necessary to analyze the batch and send the results to the notified body.