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Launching products
Do you need the right concept to bring your innovative medical device to market?
When marketing medical devices in Europe or internationally, there are legal requirements that need to be taken into consideration according to the risk classification of your medical device.
EUROPE
The introduction of the In Vitro-Diagnostic Medical Device Regulation (IVDR) and Medical Device Regulation (MDR) in 2017 fundamentally changed the situation in Europe. Medical device manufacturers now face new challenges like extended documentation obligations, the right to direct access by the notified bodies, new classification rules (IVDR), new authorized representatives, additional requirements for clinical studies prior to marketing and post-marketing clinical follow-up studies after market entry.
INTERNATIONAL SITUATION
It is of particular importance to define your target markets and to know the corresponding regulatory requirements early on in your project. Only if you specify the registration or approval strategy for your respective target markets early will you be able to market your medical device right after completing development activities.
The use of medical devices in doctors’ offices, hospitals and clinics are determined by reimbursement requirements: the use of your medical device is invoiced to health insurance providers; the practicing physician is then reimbursed according to the respective billing regulations.
medlaQ - Consulting for medical devices
Dr. Bernhard Gerstenecker
GENERAL INFORMATION
ADDRESS
medlaQ
Dr. Bernhard Gerstenecker
Scheffelstraße 9
78315 Radolfzell
Tel.: +49 172 3792283