In vitro diagnostic medical device regulation (IVDR): the end of laboratory developed tests (LDT)?-Reference-Cited by-同舟云学术

In vitro diagnostic medical device regulation (IVDR): the end of laboratory developed tests (LDT)?

Published:2021-04 Issue:2 Volume:113 Page:68-69
ISSN:1591-951X
Container-title:Pathologica
language:
Short-container-title:Pathologica

Author:

Barberis Massimo

Publisher

Siapec Servizi Srl

Subject

Pathology and Forensic Medicine

Reference8 articles.

1. Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices. Official Journal of the European Union 1998;331:1-37.

2. Regulation (EU) 2017/746 of the European Parliament and of the council of 5 April 2017 on in vitro diagnostic medical devices and repealing directive 98/79/EC and commission decision 2010/227/ EU. Official Journal of the European Union 2017;117:176-32.

3. Steele GD, Fehring TK, Odum SM, et al. Early failure of articular surface replacement XL total hip arthroplasty. J Arthroplasty 2011;26:14-8. https://doi.org/10.1016/j.arth.2011.03.027

4. Berry RB. Rupture of PIP breast implants. J Plast Reconstr Aesthetic Surg 2007;60:967-8. https://doi.org/10.1016/j.bjps.2007.01.069

5. Cobbaert C, Smit N, Gillery P. Metrological traceability and harmonization of medical tests: a quantum leap forward is needed to keep pace with globalization and stringent IVD-regulations in the 21st century! Clin Chem Lab Med 2018;56:1598-602. https://doi.org/10.1515/cclm-2018-0343

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