European Commission Drafts Updated Common Specifications for Certain Class D IVDs
The European Commission has published a draft implementing regulation amending common specifications for certain Class D IVDs under the IVDR, including HEV, Toxoplasma gondii, Plasmodium and arboviruses.
MDCG Updates Guidance on Standardisation for Medical Devices
The MDCG has updated its guidance on standardisation for medical devices, covering harmonised standards, presumption of conformity, state of the art, common specifications and EU case law.