The new Medical Devices Regulation (2017/745/EU, “MDR”) brings EU legislation in pace with technical advances, innovations in medical science, and progress in law making.
The updated Regulations create a robust, transparent, and sustainable regulatory framework that improves safety and creates fair market access for all medical device manufacturers in Europe.
All Medical Devices Stakeholders must adapt to the new European Legal Framework, especially with regards to:
- Commercialized medical devices that have to comply with the new regulatory requirements.
- Development of new medical devices that will have to target the requirements of the MDR
ASPHALION is an International Scientific and Regulatory Affairs Consultancy. We offer comprehensive support during development, manufacturing, validation, certification and commercialization of Medical Devices in Europe and United States, according to the applicable legislations.