European Commission Names Third Notified Body for MDR
The European Commission has named DEKRA Certification of Germany as the third notified body for certification under the Medical Device Regulation (MDR).
DEKRA joins BSI Assurance UK and TÜV SÜD of Germany as the only NBs that can certify devicemakers for MDR compliance.
With less than one year before the MDR takes effect, there is a severe shortage of notified bodies needed to certify products in compliance with the new requirements. Some NBs say they will not even apply for the designation (IDDM, June 21).
TGA Reviews Comments on Unique Device Identification System
Australia’s Therapeutic Goods Administration (TGA) said public comments on its proposal to set up a unique device identification (UDI) system for medical devices show “a strong consensus” in favor of the idea.
The majority of submissions called for linking the UDI database with the agency’s Register of Therapeutic Goods. Most comments urged the agency to use the International Medical Device Regulators Forum’s UDI guidance as a basis for the system, including its labeling requirements.
Some respondents proposed the exemption of low-risk devices.