June 10, 2022
The MDCG has released a new guidance document on the European UDI system, required under the MDR/IVDR. Read here for the highlights and how this impacts you ...
May 26, 2022
There is extensive activity surrounding the IVDR’s date of implementation today. Here we will discuss what is new, and the impact in the EU, Switzerland, and the UK ...
May 25, 2022
The Medical Device Coordination Group released a new guidance document; MDCG 2022-8: Regulation (EU) 2017/746 - application of IVDR requirements ...
May 24, 2022
Today the EU Commission published a ‘Notice to Stakeholders: Status of the EU-Switzerland Mutual Recognition Agreement (MRA) for in vitro diagnostic medical devices’. As expected, the EU Commission document confirms that ...
May 19, 2022
Earlier this week new Harmonized European standards were adopted to be published in the Official Journal of the European Union (OJEU). The updates can be ...
May 11, 2022
The Medical Device Coordination Group (MDCG) has issued a new Guidance Document on significant changes for IVDs. Why does this Guidance Document matter to you? Many, if not most, IVDD CE marked devices have been ...
April 14, 2022
A Notice to Stakeholders was released regarding the EU-Turkey Customs Union Agreement for medical devices. The gist of the document is ...
April 4, 2022
The In Vitro Diagnostic Regulation (IVDR) introduces a complex conformity assessment process for high-risk IVDs, including sample verification of Class D products before they can be ...
March 22, 2022
It is no surprise, but there are major concerns regarding whether the industry is ready for the transition period to ...