The in vitro diagnostic (IVD) devices sold in the European Union require a CE mark to certify that the device complies with the current European In-Vitro Diagnostic Devices Directive (IVDD 98/79/EC). The CE mark is a quality certification indicating that the device may be legally commercialized in the European Union. The regulatory framework in Europe is undergoing significant changes with the new In Vitro Diagnostic Regulation (IVDR 2017/746) coming into full force in 2022. This will result in substantial and necessary changes to the regulatory requirements for IVDs.
IVD device classification in Europe
Under the IVDD there are four classes of IVDs:
- General IVD (Self-Certified)
- Self-Testing IVD
- List B IVD (Annex II)
- List A IVD (Annex II)
Under the IVDR, there will be four risk-based classes:
- Class A
- Class B
- Class C
- Class D
Most self-testing IVDs will fall under Class C, and many IVDs currently classified as self-certified will be classified as higher risk (such as the self-certified test for COVID-19).
The CE conformity assessment process for IVDs is similar to that of medical devices, although with some significant key differences. There will also be changes to this process once new IVDR is enforced in Europe. Sign up for our free webinar on the CE Marking process for IVD to learn more about this and download a copy of the IVDR.
IVD Technical file preparation for CE Marking
IVD manufacturers should compile a technical file or design dossier showing compliance with 98/79/EC. The IVD technical file has to include information about the design, intended use, risk assessment, and route to conformity with IVDD requirements. Based on the IVD classification and conformity assessment route, the technical documentation may need to be reviewed by a Notified Body (NB) before a CE marking certificate can be issued. Once the technical file is completed, it must be made available to European Competent Authorities upon request.
As part of our regulatory services, AKRN can assist with the following:
- Identify the proper IVD classification
- Determine specific testing requirements
- Determine applicable standards and MEDDEV documents
- Determine compliance with Essential Requirements of 98/79/EC
- Review technical documentation to identify and address any gaps
- Perform a literature review and Performance Evaluation Report (PER)
- Assist with Notified Body selection and communication
- Provide an official EAR (European Authorized Representative)
- Conduct a risk assessment per EN ISO 14971:2012.
- Develop post-market surveillance (PMS) procedures.
- Support with ISO 13485:2016 implementation