Medical device CE marking

Regulation (EU) 2022/1107 issued on IVDR common specifications for certain class D devices


The European Commission has adopted common specifications for several types of high-risk diagnostics, such as HIV tests and SARS-CoV-2 tests. The specifications set uniform and rigorous benchmarks for tests across the EU, clarifying the requirements for market actors and protecting EU patients.

The document can be downloaded in our library

Source: European Commission