With the recent adoption of the EU Medical Device Regulation (MDR) and the further development of the EU MEDDEV guidelines, the demands for successful conformity assessment of medical devices have become more extensive The new laws and regulations considerably increase the effort for you as a manufacturer, both in terms of time and expertise, to meet the requirements for the conformity assessment. Once you have obtained a CE certification for your product, market access becomes the next main focus. In most cases, eligibility for reimbursement by statutory health insurers is essential for commercial success. In Europe, this is regulated at a national level.
Together we can successfully bring your medical device to market, using our comprehensive set of skills and services - from initially analysing study data to negotiating a reimbursement price consistent with the value of your product.
- Strategic consulting on reimbursability in Germany
- Statistical consulting regarding study design, planning of clinical studies and quality assessment of studies
- Statistical analyses
- Support in clinical evaluations
- Preparation of advice request documents to national (G-BA, i.e. Federal Joint Committee) or European (EMA/EUnetHTA) authorities
- Support throughout the European HTA process, e.g. Early Dialogue and preparation of the Evidence Submission File
- Preparation of HTA documents for the benefit assessment of medical devices according to German laws and regulations (in accordance with SGB V, section 137h)
- Preparation of applications for testing examination and treatment methods (in accordance with SGB V, section 137e)
- Preparation of guidelines for hospitals (e.g. NUB applications for new examination and treatment methods)
- Compilation of evidence base through systematic searches of literature databases and study registries
- Support with the preparation for the Written Statement and Oral Hearing in the assessment process with the G-BA in Germany (in accordance with SGB V, sections 135, 137c, 137h)
- AMS also supports you in planning and execution of clinical studies of your medical device before and after CE certification.