Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Comment
. 2021 Apr;113(2):68-69.
doi: 10.32074/1591-951X-237. Epub 2021 Mar 18.

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

Massimo Barberis  1
Affiliations
Comment

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

Massimo Barberis. Pathologica. 2021 Apr.
No abstract available

PubMed Disclaimer

Conflict of interest statement

Conflict of interest

The Author declares no conflict of interest.

Comment on

References

    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.
    1. 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.
    1. 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 10.1016/j.arth.2011.03.027 - DOI - PubMed
    1. 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 10.1016/j.bjps.2007.01.069 - DOI - PubMed
    1. 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 10.1515/cclm-2018-0343 - DOI - PubMed

Substances

LinkOut - more resources