After four years of negotiation, the European Parliament has published the text of its EU Medical Device Regulation (MDR), setting the stage for sweeping changes across the medical device value chain.
As expected, medtechs will bear the brunt of the costs of complying with the new regulation. To reduce the costs - and execution hazards - associated with implementation, we recommend companies take a risk-based approach to compliance that involves a detailed assessment of the revenue impact, as well as the cost and complexity of remediation. By outlining a thoughtful, well-ordered approach now, medtechs can protect valuable and future revenues while making upgrades to critical business functions.
