Getting Ready for IVDR

“The global IVD market is projected to reach USD 113.1 billion by 2026, from USD 98.2 billion in 2021, at a CAGR of 2.9% during the forecast period. The growth of the IVD market is mainly driven by the rising geriatric population and the subsequent growth in the prevalence of chronic and infectious diseases…” says In-Vitro Diagnostics/IVD Market, Published Date: Mar 2022 | Report Code: MD 3609 In the EU, companies that manufacture IVDs must adhere to the new In Vitro Diagnostic Regulation (IVDR) in order to sell their products within the EU. IVDR replaces the previous In Vitro Diagnostic Directive (IVDD). Similar to MDR, the goal of IVDR is to standardize products and processes, improve pre-market and post-market surveillance, and encourage patient safety.

Manufacturers are currently facing new requirements under IVDR 2017/746, issued by the European Commission, which include more stringent mandates such as increased accountability, detailed documentation and regular filings to the new EUDAMED database.

The most significant change is the new product classification system, and the requirement that manufacturers of IVD devices must consult a Notified Body for approval. Just like the EU Medical Device Regulations, the In Vitro Diagnostic Medical Devices Regulation obliges keeping “clear and precise” language for all the technical documentation submitted to the Notified Body and patient information materials. These document needs to be written in a way that it is fully understood and no ambiguity is created, irrespective of who is reading the document.

At Janus, we fully understand those implications, and are able to quickly implement the changes your company finds relevant. We are able to provide support for the medical sector and use expert linguistic resources to ensure that the translation provided is of a standard fully acceptable to the appropriate regulatory authorities. We are aware that the life sciences industry uses niche terminology, symbols, and icons that are specific only to that market.  Also, our structured LQA framework provides customers with an objective, consistent and metric-driven approach to quality assessment, ideal if you search for no ambiguity and clear translations. More here: https://janusww.com/publications/no-news-is-good-news-right/ Reach out to us to ensure you are prepared for latest medical regulations.