By Erica Kramer, Ph.D., Nerac Analyst
Originally Published: November 14, 2017
The global in vitro diagnostics (IVD) market was worth about $61.1 billion in 2016 and is projected to grow to $84.6 billion by 2023, with Europe accounting for the second largest market share after North America. The expected market growth, and increased interest in the field by consumers, makes in vitro diagnostics an attractive arena for research, development, and commercialization; however, market growth is expected to be hampered by factors such as price sensitive markets, inadequate reimbursement policies, and stringent government regulations, such as the new European in vitro diagnostics regulation. This article explores the significant changes manufacturers will notice. Read more here!
Get Our Free Article
Simply fill in the form below, verify your email address
and you’ll be sent a link to download our free article.
- 56By Robert Zott, Director of Advisory Services Development Originally published March 27, 2018 It’s easy to read Europe’s Clinical Evaluation Guidance Document MEDDEV 2.7/1 Revision 4 (referred to as “Rev. 4”) and come away with the impression that clinical data—whether in the form of investigations carried out by the manufacturer of a medical device or…
- 52By Ron Sills, Nerac Analyst Originally Published: September 29th, 2014 The European Union’s Council Directive 93/42/EEC concerning medical devices contains the essential requirements to be met by medical device manufacturers in order to market their products in the 28 member countries. A technical file for Class IIa and IIb devices, or a design dossier for…
- The New Post-Market Surveillance Regulations for Europe, Part 2: Serious Incidents Get A Serious Overhaul.51By Robert Zott, Director of Advisory Services Development Originally published November 13, 2018 There is now 1 year, 6 months and 20 days until the application date upon which the new European Medical Device Regulation (MDR) goes into effect. For those charged with the task of upgrading systems for MDR compliance, that’s 567 days or…