The European Commission keeps publishing new documents. A key document that provides the regulatory foundation for many CE marked devices, among others medical and IVD medical devices is the Blue Guide. The Blue Guide is a horizontal guidance document that clarifies concepts like placing on the market, principles of CE marking and other essential aspects. It should be cross-read with regulations like (EU) 2017/745 and 2017/746 on medical devices and in vitro diagnostic medical devices (MDR and IVDR). The following new version was published:
- ‘Blue Guide’ on the implementation of EU product rules 2022
Furthermore, the Commission continues expanding the list of harmonized standards under MDR and IVDR:
- The MDR and IVDR now also list EN ISO 14971:2019. Industry anxiously waited for this step.
We highly recommend to keep a close eye on the development of the harmonized standards list. The European Commission is expected to provide updates every 3 to 4 months.
Source: European Commission