Legal Manufacturer & Medical Devices
New Challenges under the MDR
Are you also facing the decision of possibly having to give up your business with medical devices composed of substances due to regulatory and financial hurdles?
The new Medical Device Regulation (MDR) places increased demands on the safety and performance of medical devices, making authorization and classification more difficult. Manufacturers, authorized representatives, importers and distributors face new challenges, including possible new classification rules that require a notified body in the conformity assessment procedure. But don't worry, we are here to support you.
We assume the role of responsible manufacturer as defined by the MDR
Euro Vital Pharma has been a competent and reliable partner for all questions relating to substance-based medical products for 25 years. We have extensive experience and expertise in the consumer healthcare sector, distribute our own IPs in numerous countries and channels and are therefore always up to date with the latest regulatory requirements.
We are not just there to advise you. Rather, we take on the role of responsible manufacturer for you within the meaning of the MDR. This means that we assume full responsibility for the quality and safety of your products.
The advantages for our customers:
You can market and distribute your products under your own brand name. The name and address of Euro Vital Pharma GmbH only appear on the packaging and the instructions for use. The purely physical manufacture of the products can be outsourced to one or more suitable contract manufacturers.
Quality without your own quality management system. With our fully certified quality management system, we bear full responsibility as a manufacturer, including production monitoring and approval for placing on the market. This means that our customers fulfil all the requirements of a MDR quality management system and ISO 13485 without having to establish their own system.
With our expertise and diverse cooperation models, we create opportunities to keep your product on the market. Let us work together to find a solution that meets your needs.
Of course, we also welcome your interest in our own Medical Devices, for which we are always on the lookout for sales partners. You can find an overview in our product catalogue here (click on the "Medical Devices" checkbox in "Categories").
We look forward to your special requirements - please contact us: email@example.com
25 years of experience in marketing our own medical devices
Assumption of the function of responsible manufacturer within the meaning of the MDR
Flexible cooperation models tailored to your requirements