MDR

$ 16.5b market advantage revealed for medtech firms seizing the MDR compliance opportunity

Maetrics, the global consultancy firm that provides regulatory, quality, and compliance solutions to the life sciences sector, today publishes new research quantifying the competitive advantage that medical device manufacturers can seize by moving quickly to comply with the new European Medical Device Regulation (MDR). Across the EU’s ten largest economies plus Switzerland, the Market Opportunity Value for compliance pioneers is estimated to be $ 16.469 billion.

The MDR is designed to improve both clinical safety and fair market access for all medtech players, and following its publication on May 5th, 2017 a three-year transition period was outlined. However, there is a rapidly emerging capacity shortage both among Notified Bodies - tasked with certification - and expert compliance staff and consultants, meaning that manufacturers may find themselves unable to complete compliance across their product portfolios by the statutory deadline if they delay their preparations.

Peter Rose, Managing Director Europe, at Maetrics comments: “Our research serves to highlight the scale of market advantage available to early movers who will be certified to service market segments from which non-compliant manufacturers will – for a period – be excluded. It is widely recognised that there are already issues with capacity, both in terms of in-house compliance skills and external certification capabilities, and this offers early movers a clear competitive advantage, just as much as it poses temporary market access problems for late MDR adopters.

“We would urge medtech firms to develop and implement a proactive MDR compliance strategy now. Compliance and regulatory support will need to be a high priority for medtech CFOs and FDs planning for 2018. With proper support regulatory departments can audit the product portfolio, eliminating any marginal and unnecessary products, appoint team members to take responsibility for specific processes and adaptions, and book in with Notified Bodies for certification as soon as the NBs themselves are compliant.”

Table 1: The value of medical device markets from which non-compliant manufacturers will be excluded – highlighting the scale of the opportunity available to early mover compliance pioneers

About Maetrics Founded in 1984, Maetrics is a global life sciences consulting firm focused exclusively on regulatory, quality, and compliance solutions for Medical Device, Diagnostic, Pharmaceutical and Biotechnology companies. With offices throughout Europe and North America, Maetrics can assist with local, regional, or global compliance needs.

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