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 essential basis here is the German Social Code V (health insurance).

The SGB V is very financially and adminstrative-heavy. Concepts and topics such as evidence, studies, quality assurance, benefit assessment, additional benefit, patient use have taken a stronger influence in SGB V in the last few years. This applies in particular to the assessment of new active substances, new indicative areas of active substances, new methods of examination and treatment, improvement of quality of life, reduction of the duration of the illness or cost-benefit evaluations.

German institutes, such as the Joint Federal Committee (Gemeinsamer Bundesaussschuss) or the IQWIG, have been given SGB V. The Joint Federal Committee in particular has a decisive influence on the real supply and treatment situation. This can be done through decisions or guidelines. Comments may or may need to be sought.

Did you know that the top organization of medical technology manufacturers in the SGB V also played a role? These are then included when it comes to ensuring the quality of the service or the assessment of new methods of examination and Treatment (look after §§ 92, 135,137c, 137e SGB V).

We are constantly experiencing the fact that international medical technology manufacturers and LifeScience companies are not fully aware of the importance of SGB V for distribution in Germany.

Continue Reading "International manufacturers are hard to reach the German market"

Method evaluation (according to § 135 and 137c SGB V) and testing of examination and treatment methods (according to § 137e SGB V) The G-BA has the statutory mandate to ensure the adequate, appropriate and economic care of the insured according to scientific criteria through its guidelines. Within the framework of a structured evaluation procedure, G-BA reviews diagnostic and therapeutic methods – Use, – medical necessity and – Economics. For new methods of examination and treatment, the benefits of which are not yet sufficiently documented,…Continue Reading “German Market Access – Method evaluation and testing of examination and treatment methods”