title: [Marketing approval and market surveillance of medical devices in Germany: Where does policy integration take place?].
abstract: Since 2011 new regulatory measures regarding medical devices have been set up with the aim to eliminate obstacles to innovations and to find more coordinated ways to marketing authorisation and market surveillance. This essay investigates whether these new and existing coordination mechanisms build up to a Joined-up Government approach. The analysis shows that the regulatory process should be adjusted along several dimensions. First, many organisations lack awareness regarding their stakeholders and focus solely on their immediate organisational activities. Second, the regulatory process (marketing authorisation and market surveillance) is too fragmented for an effective communication to take place. Finally, the underlying strategy process is an ad-hoc approach lacking continuity and continued involvement of, in particular, the responsible federal ministries.
authors: Universität Konstanz, Fachbereich Politik- und Verwaltungswissenschaft, Konstanz. Electronic address: Achim.Lang@uni-konstanz.de.
authors: Achim
authors: A
authors: Lang
mesh_terms: D018795:Device Approval / Q000331:legislation & jurisprudence / Q000592:standards*; D004059:Diffusion of Innovation; D004864:Equipment and Supplies / Q000592:standards*; D005858:Germany; D006291:Health Policy / Q000331:legislation & jurisprudence*; D006801:Humans; D040541:Marketing / Q000331:legislation & jurisprudence / Q000592:standards*; D009313:National Health Programs / Q000331:legislation & jurisprudence / Q000592:standards*; D011057:Politics; D011358:Product Surveillance, Postmarketing / Q000592:standards*
keywords: Medical devices; Medizinprodukte, Regulierung, Politikintegration, Marktzulassung, Marktüberwachung; and market surveillance; marketing authorisation; policy integration; regulation