Nov 25, 2020

Two documents published by the European Commission (EC) will be of interest to those watching the changing European regulatory landscape for medical devices and IVDs: guidance on IVDR classification rules and a new attempt to call for harmonized standards under MDR and IVDR.

MDCG guidance provides information on IVDR classification rules

The EC released a 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. This guidance, which has been the subject of much anticipation within the industry, outlines the IVDR classification rules and provides the rationale and illustrative examples for each rule.

This is an important guidance for economic operators as the IVDR introduces a new rule-based classification system that will subject IVDs in the EU to a higher degree of scrutiny; many IVDs that have been self-certified under IVDD will now require Notified Body (NB) intervention. In addition to economic operators, the guidance applies to diagnostic or information society services performed on EU patients or devices put into service through distance sales.

EC drafts another standardization request for MDR and IVDR

The EC also published a new draft standardization request for the development of new and revised harmonized standards under the MDR and IVDR. This comes after the European Committee for Standardization (CEN) and the European Committee for Electrotechnical Standardization (CENELEC) rejected a previous request from the EC in June 2020. This new 40-page request notably includes new standards to be drafted, which are listed in Annexes I and II.

Additional European MDR and IVDR compliance resources from Emergo by UL:


  • Timothy Herr