The European Commission (EC) has published new guidance on In Vitro Diagnostic Regulation (IVDR) classification, alongside justification and examples for the rules.
The new Medical Devices Coordination Group (MDCG) document, ‘MDCG 2020-16: Guidance on Classification Rules for In Vitro Diagnostic Medical Devices under Regulation (EU) 2017/746’, sets out a new rule-based classification system that subjects in vitro diagnostics (IVDs) to a higher level of scrutiny. Many IVDs that were self-certified before will now require intervention from a Notified Body.
Furthermore, the European Commission has also released a draft standardisation request for the development of harmonised standards under the Medical Devices Regulation (MDR) and IVDR. The European Committee for Standardisation (CEN) and European Committee for Electrotechnical Standardisation (CENELEC) rejected a previous request from the EC earlier this year.