ARTICLE SUMMARY:
Despite some increase in activity, notified body designations under the EU Medical Device Regulation have come in at a glacial pace. A perspective from our sister publication MedTech Strategist Market Pathways: Global Reimbursement, Regulatory & Policy Review.
Probably the most immediate concern regarding the impending European Medical Device Regulation (MDR) is the timeline within which the new regulatory framework is scheduled to be implemented.
