Premarket evaluation of medical devices: a cross-sectional analysis of clinical studies submitted to a German ethics committee.

ABSTRACT:

Objective

To assess the methodological quality of pre-market clinical studies performed on medical devices (MDs), including in-vitro diagnostic (IVD) MDs, in Europe.

Design

Observational cross-sectional study.

Setting

A large German ethics committee.

Materials

From the consecutive sample of study applications between March 2010 and December 2013, we selected MD study applications requiring approval by an ethics committee and the competent federal authority. These included pre-market studies on devices that had not yet received a CE (Conformité Européenne) mark or had previously been CE marked for a different indication. Also included were post-CE studies requiring federal authority approval because the study entailed additional invasive or otherwise burdensome

SUBMITTER: Sauerland S 

PROVIDER: S-EPMC6398724 | biostudies-literature | 2019 Feb

REPOSITORIES: biostudies-literature