Two manufacturing facilities across Europe have received IVDR certification following the transition away from IVDD.
Switzerland-based vitro diagnostic company AliveDx has announced it received an In Vitro Diagnostic Regulation (IVDR) certification for its manufacturing sites in the UK and Switzerland.
Both sites, one in Edinburgh, UK, and the other in Eysins, Switzerland, received the IVDR certification through EN ISO 13485: 2016. An international standard for quality management systems (QMS), it proves the manufacturers’ ability to meet the IVDR quality conditions.
The certification will allow the in vitro diagnostic solutions (IVDs) provider to continue to sell in the European Union (EU) as the industry moves away from IVDD.
The IVDR certification replaces the previous In-Vitro Diagnostic Medical Device Directive (IVDD) after it was published in May 2017.
AliveDx CEO Manuel O Méndez said: “The IVDR certification is a significant milestone for our organisation. It reinforces our unwavering commitment to partner with our customers in providing high-quality in vitro diagnostic solutions. We are dedicated to upholding the highest standards of quality, safety, and compliance. It is a testament to our pursuit of excellence to empower diagnostics insights, transform patient care and innovate for life.”
Last month, AliveDx secured three CE marks for their automated MosaiQ solution, to facilitate the instant diagnosis of connective tissue diseases (CTD).
