Month: March 2019

The EU Commission has released draft documents correcting aspects of the Medical Device Regulation (MDR) 2017/745 and In Vitro Diagnostic Regulation (IVDR) 2017/746. These drafts are currently under review by the EU Competent Authorities with comments expected by 20 March 2019. You may locate these documents by clicking on the links below: Draft Document for … Continued

Often overlooked, Article II7 of the European Union’s (EU) Medical Device Regulation (MDR 2017/745) lurks within Chapter X of the Final Provisions. However, this article is of high impact to market authorisation holders who provide medicinal products integral with administration devices. Specifically, it states that manufacturers of administrative devices must seek the opinion of a … Continued