Sales & Marketing
EU Market Entry
TRIQ has decades of experience in the medical devices industry at all levels of complexity and applications. Our team of experts can assist you in preparing for the positioning and market entry of your Medical Device in compliance with EU 2017/745 MDR Art. 5 and Art. 10 and all applicable national regulations.
Prerequisites
The requirements of the Medical Device Regulation (MDR) are intricate and necessitate experience and expertise in medical devices to successfully place your product in the EU market or other regions including the UK. Key prerequisites include:
- Classification of the medical device according to MDR to obtain CE mark
- CE mark received from Certified Notified Body (except class 1)
- Evidence of safety and efficacy based on sufficiently powered clinical data/trials
Sales & Reimbursement
Obtaining the CE label may be a prerequisite for being able to sell your product legally in the EU. Still, without reimbursement from the health insurers and/or government, the market will only be limited to a few private sales. The EU medical market is very regulated and driven by the fact that, in the leading countries, statutory health insurance covers most citizens. The national regulations significantly impact the requirements to be fulfilled to receive reimbursement from the health insurers or government, wherever applicable.
Please refer to the TRIQ Health Economics and Reimbursement page.
TRIQ Sales & Marketing GmbH is your competent partner for selling and distributing your medical product in the EU market. TRIQ has years of experience working with healthcare providers. TRIQ medical devices expertise is widely recognized and trusted, a sound basis for long-term sales and product support.
With an extensive distribution and logistics network, we can ensure a robust market entry with rapid turnover and enhanced safety measures.We believe in the advantages for both parties to continue the relationship and to use the extensive product knowledge to its best value to place your medical product successfully on the market.
TRIQ can also offer sales and marketing services to new customers. Don’t hesitate to get in touch with us so that we can discuss your needs.