With just six months for the EU Medical Devices Regulation (MDR) to come into full implementation, medical device manufacturers need to start and prepare for the significant changes coming up or they may be at a risk of getting their products removed from the EU market.
As an essential response to technical and scientific developments that are rapidly shaping the medical device industry in the EU region, the EU MDR is expected to create a robust, more transparent, safe monitoring and secured Regulatory framework for the supply of medical devices. With the transitional period for the EU MDR approaching soon i.e., on May 26, 2020, the key factors that device manufacturers must consider include:
- Till May 2020, manufacturers can either comply with the existing MDD Regulatory requirements or align with the new MDR. But post May 2020, they will have to renew their existing CE certificates, and all the new devices must be aligned with the new MDR.
- Defining necessary pathway strategies for the Regulatory transition.
- Creating a post-market surveillance (PMS) plan to monitor the safety profile of the products.
- Carrying out a gap analysis between the existing MDD and the new MDR/IVDR so the Regulatory issues can be addressed in time.
- Submitting a QMS (quality management system) report for conformity assessment by Notified Bodies along with the other technical documents.
With the transitional period coming to an end, manufacturers are obliged to consider the above-mentioned key factors without fail for successful compliance. We say now is the time to prepare yourself and be ready. Gain complete insight on the EU MDR by partnering with the best in the field. Stay informed. Stay compliant.