Germany's New High-Risk Assessment Medtech Scheme Off To Slow Start
Germany's new testing and treatment methods (NUBs) scheme for assessing benefit in high-risk products for inpatient use recently processed its first batch of applications. But, as with its longer-established outpatient products counterpart, it does not seem to be an instant success, says German reimbursement expert Ben Modley.
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Germany's introduction of benefit assessments for class IIb and class III medical devices, and the impending EU Medical Device and IVD Regulations will place an unquantified strain on medtech manufacturers in Europe's largest market. But new innovation schemes are adding more dimensions for businesses locally.
Germany’s system for fast-tracking selected, insufficiently proven ambulatory medtech products into commercial use seems to be falling short of its potential. This has set alarm bells ringing in an industry that is already concerned about its inpatient pass-through scheme (NUBs).
BVMed says the EU and the UK should set up a system of mutual recognition of medical device regulation to kick in when the UK’s EU exit transition period ends on 31 December.