EU & US: MDCG Issues Guidelines on Medical Device Standardization and Changes to the List of US FDA

ARQon
Jul 8, 2021
1 min read

In April 2021, the Medical Device Coordinating Group (MDCG) of the European Commission has released a new guidance on the role of safety and performance criteria in current Medical Device Directive (MMD) as well as upcoming Medical Device Regulations (MDR) & In-vitro Medical Devices Directive (IVDR).

The guidance explains 4 main topics as per below:

1. EU legislation on medical devices within the “New Approach” and the “New Legislative Framework”

2. The general framework for harmonised European standards

3. Harmonised European standards in support of the EU legislation on medical devices

4. Governance structure for standards in the medical devices sector

Detail information can be found in Guidance on standardisation for medical devices.

The US Food and Drug Administration has modified its list of standards that FDA recognizes to be used during premarket evaluations. This publication entitled Modifications to the List of Recognized Standards, Recognition List Number: 047 will assist manufacturers who choose to declare conformity with consensus standards to meet certain requirements for medical devices.

This publication was published in the Federal Register on August 21, 2017 and it goes into effect immediately.

Sources:

Guidance on standardisation for medical devices

Modifications to the List of Recognized Standards, Recognition List Number: 047