Report of the Advisory Council on the Assessment of Developments in the Health Care Sector for 2014 on medical devices
In its 2014 report, which was presented in June, the Advisory Council on the Assessment of Developments in the Health Care Sector (http://www.svr-gesundheit.de) carried out an analysis of the regulation and reimbursement of medical devices. Chapter 3 analyses in detail their definition and classification, market overview, regulation and reimbursability in the German health care system.
On the basis of this analysis, the Advisory Council arrives at far-reaching recommendations, which above all address regulation at European level, something that experts, including HTA.de, have long been calling for. These include a “Europe-wide central and independent approval (…) at least of medical devices of classes IIb and III”, evidence of clinical effectiveness, registration of clinical studies, etc. (paragraph 65).
It will be interesting to see whether the German government makes use of these proposals in the context of the deliberations on the reform of EU medical device law.
Full text available at: http://www.svr-gesundheit.de/index.php?id=485
Joint press release of HTA.de and DNEbM on the 2014 report