EU Medical devices: more safety, more traceability

After a long and tenacious struggle, the path for the new European legal framework for medical devices and in vitro diagnostics is finally free. The corresponding regulations were adopted today in the European Parliament at second reading. For many years […]

International manufacturers are hard to reach the German market

Are you familiar with regulation (CE)? You know what to expect from the new MDR and IVDR 2017? Then they did your homework, do you think? In Germany, 90 per cent of people are insured under statutory health insurance. The […]

EU MDR and EU IVDR (In Vitro Diagnostic)

The new European Medical Device Regulation (MDR) and the EU Regulation on In Vitro Diagnostics (IVDR) will replace the existing Medical Device Directives. The timetable for the publication has shifted further. Meanwhile one goes from summer 2017 out. Manufacturers are […]

New diagnostic and therapeutic methods must demonstrate evidence

There is a large difference between the use of the CE mark and the evidence for the reimbursement by German statutory health insurance funds.

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