Steps for Getting CE Marking

Until today, medical devices were complying with the Medical Device Directive to sell their products in Europe. However major amendments are made in the current MDD to keep up with the growing technological advances in healthcare and medical devices. Typically, all MDD-MDR transition projects initiate with Gap Assessment. Gap Assessment is a crucial activity during MDR transition & our team with engineering & regulatory expertise are well equipped to conduct this activity with an analytical mindset, resolve any regulatory concern and develop robust regulatory strategy for medical device manufacturers. IZiel team of specialists and quality professionals look forward to support more medical device companies to file their devices under the MDR 2017/745.

  Why is the modification in the regulation ( MDD to MDR Transition ) adapted? History : You may be aware of the breast implant scandal in France wherein instead of medical grade Silicon, a low-quality Silicon was used as a raw material for breast implants which got ruptured and there were several complaints filed which led to the recall of the device by the manufacturer. Because of these kinds of incidents, the MODIFICATION to MDD came into the picture and it’s called MDR, which is more comprehensive and detailed than MDD. How do we adapt to MDR? ·          Gap analysis while considering additional requirements of MDR. ·          Refer Annexure XVII of MDR MDR focuses on the safety and performance assurance of the devices placed on the market. MDR assures that the product causes no harm to the customers. Clinical and Non-Clinical testing methods include Clinical Investigation, PMCF studies, ...