title: [Data transparency regarding medical devices - the position of the medical device industry].
abstract: The medical device industry, strongly dominated by medium-sized firms, has significant growth potential and a high number of job opportunities with 170,000 employees in more than 11,000 companies. Approximately one third of the business volume is achieved with innovative products that are less than three years old. The safety, quality and efficiency of the products is tested and approved by CE certification. Due to the heterogeneous field of devices, however, evidence requirements must be differentiated according to the type of device in question. Transparency is as important as the type of evidence, and industry is well aware of the significance of transparency for credibility in the market. Industry believes that all the stakeholders affected must collaborate to define the evidence requirements and decide which data are necessary to assess the benefits of a technology. Before a consistent level of transparency can be achieved, however, it is crucial to jointly develop a framework of requirements including invasiveness, risk potential, patient-relevant endpoints and intended use of the technology, as well as the data source. Transparency is a process that can only be achieved if all stakeholders cooperate successfully. Also, it is important to keep in mind that the development of study designs and reliable evidence needs time. In the interest of all patients it is essential to maintain an innovation-friendly climate in Germany.
authors.affiliation: B. Braun Melsungen AG, Melsungen.
authors.forename: Gabriela
authors.initials: G
authors.lastname: Soskuty
mesh_terms: D022126:Access to Information / Q000331:legislation & jurisprudence*; D003299:Cooperative Behavior; D018795:Device Approval / Q000331:legislation & jurisprudence*; D004869:Equipment Safety; D005858:Germany; D006801:Humans; D007221:Industry / Q000331:legislation & jurisprudence*; D033183:Interdisciplinary Communication; D011643:Publishing / Q000331:legislation & jurisprudence*; D016032:Randomized Controlled Trials as Topic / Q000331:legislation & jurisprudence; D018570:Risk Assessment