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!
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- 57By Erica Kramer, Ph.D., Senior Nerac Analyst/Medical Writer Originally Published: June 30, 2020 In May 2017, the European Parliament and Council published Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR), repealing Directive 98/79/EC (IVDD). The new regulation will apply starting May 26, 2022. Unlike under the IVDD, which allowed for self-certification for many…
- 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…
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