What is Regulation EU 2017/745 on medical devices (MDR)?
Published in May 2017, the MDR is formally the definitive regulation governing the marketing of medical devices within the European Economic Area (EEA). The regulation is based on a lifecycle approach and replaces both the Active Implantable Medical Devices Directive (AIMDD) 90/385/EEC and the Medical Devices Directive (MDD) 93/422/EEC. The MDR strengthened regulatory emphasis on clinical data and clinical evaluations while elaborating guidance pertaining to post-market evaluations and vigilance efforts.
How can we help?
The transition from the MDD to the MDR poses strenuous demands on manufacturers. In order to be compliant with the MDR requirements, manufacturers will need to assess their Quality Management System and the technical documentation of their products and close any gaps. Conducting this gap analysis can be time consuming and costly. Li-Med’s Experts have years of experience navigating the ever-changing international regulatory medical device environment and can help ease the transition process for your company.
We additionally offer our services as the Person Responsible for Regulatory Compliance (PRRC), a new requirement set by the MDR to ensure regulatory compliance