Thanks CroMagnon, but note that from your reference this is a...

Thanks CroMagnon, but note that from your reference this is a common problem with medical devices, however there is a proposed solution in the case of Germany: 'During the last seven years, we have provided consulting services to more than 100 different medical device startups. Some of them planned to obtain the CE mark for their product relatively quickly and launch it in Germany. The problem was getting those German Sickness Funds (payers) to provide reimbursement in a timely manner.'
The solution:
'According to the recently enacted law for the Restructuring of the Statutory Health Insurance (GKV-Versorgungsstrukturgesetz), instead of denying reimbursement for procedures or devices that do not yet fulfill all of the conditions required to meet the threshold, the G-BA can now decide to provide funding for a “controlled study.” Within the timeframe of the controlled study, the manufacturer may be able to reach the aforementioned threshold.'

The other point to make is that the company can always go back to the EMA and obtain a Scientific Opinion subsequent to the CE Mark being given. The big issue is to get the CE Mark to get the sales. Hospitals will lap up the product because it will save them money.