The Medical Device Coordination Group (MDCG) has issued this June 2022, a position paper on the need for manufacturers to ensure timely compliance with MDR…
Clinical trials for medicinal products and IVDs: interface between two Regulations
The Medical Device Coordination Group (MDCG) published a Q&A document on the interfaces between two Regulations. Specifically, the Regulations involved are the Regulation on clinical trials for…
New Version of the Italian CND is now available!
On January 24, 2022, the Italian Official Journal published the Decree aiming to amend and update the Medical Device National Classification (CND). The CND groups…
From today, the new IVDR applies!
From May 26, 2022, the new Regulation on in vitro medical devices applies! IVDR fully applies from May 26, 2022 CE Certificates issued under the…
IVDR: New MDCG Template on Summary of Safety and Performance
IVD manufacturers of highest risk classes shall be informed of an important template endorsed by the MDCG: 2022-9 the Summary of safety and performance Template.…
IVD: What is the status of the Mutual Recognition Agreement between the EU and Switzerland?
From May 26, 2022, the agreement between Switzerland and the European Union on mutual recognition for the market of in vitro diagnostic medical devices will…
New MDCG Guidance on IVDR legacy requirements and Q&A on UDI!
The Medical Device Coordination Group (MDCG) has released two very useful guidances: one concerning the application of IVDR requirements to “legacy devices” and devices placed…
IVDR: Harmonised standards for QMS and risk management
May 26, 2022, is an important date for all stakeholders of the IVD sector. The new Regulation on in vitro diagnostic medical devices (IVDR) will…
What is a significant change? New MDCG Guidance for IVD legacy devices
The new Regulation on in vitro medical devices (IVDR) will start to apply on May 26, 2022. For manufacturers, we want to highlight two crucial…
IVDR: 7th Notified Body on NANDO!
The NANDO database has a new Notified Body under the IVDR! 3EC International a.s. is the 7th EU Notified Body notified under the Regulation (EU) 2017/746…