The new EU Medical Device Regulation (MDR), finally published by the European Parliament in May 2017, presents a new regulatory framework designed to ensure the highest level of safety within the medical devices.

Peter Rose, Managing Director Europe, Maetrics, writes: “The regulation introduces sweeping changes to manufacturing compliance duties – summarised in the box right – and although a deadline of 2020 has been set, it is important that manufacturers start their compliance preparations as soon as possible.

“One of the main factors behind the compliance urgency is the serious question mark over the industry’s capacity to accommodate the preparation and certification work necessary for the complex changes. The capacity bottleneck is twofold – there is mounting pressure on the current range of Notified Bodies responsible for servicing the industry’s compliance assessment and certification needs, alongside a rising shortage of suitably qualified in-house compliance professionals. Based on interviews with major medtech players operating in Europe, we estimate the impact of likely under-capacity to be in the region of 20 per cent of total market value.

“This impending capacity gap will undoubtedly catch out those manufacturers which rest on their laurels and do not seize the compliance initiative quickly enough. We believe that late movers will find themselves temporarily excluded from lucrative markets that they will not be certified to service, and conversely, compliance pioneers will step in and capitalise on their counterparts’ disadvantage.

“To quantify the compliance opportunity, we have devised a MDR Market Opportunity Value model (MOV) that demonstrates in clear financial terms the value of the medical devices markets available to fully MDR-compliant manufacturers. The potential revenues are substantial: $16.5 billion across the EU’s 10 largest economies plus Switzerland. Of course, this figure not only highlights the scale of opportunity available to early-movers but also the impending revenue penalty facing compliance late-movers.

“So how can medtech firms take action to avoid falling behind? Our key recommendations for manufacturers are:

Develop and implement a proactive and pragmatic MDR compliance strategy as soon as possible;
Appoint team members from different departments of the business to take responsibility for certain processes;
Audit the product portfolio and remove any unnecessary products;
Partner up with experienced compliance professionals who can provide guidance through the transition and help develop a comprehensive plan of action;
Book in with Notified Bodies for certification to occur as soon as the NBs are compliant themselves.

“The extent and complexity of the changes brought in by the MDR place unprecedented demands on the medical devices industry. It is difficult to see how the combined issues of regulatory under-capacity and in-house skills shortages will be remedied, with the inevitable consequence that many manufacturers simply will not be able to service their European markets for a while.

“It is therefore imperative that manufacturers set themselves on the path to early compliance and avoid the penalties of market exclusion, particularly given the likelihood that late adopters may never win back the market share that they lose to the pioneers. Compliance outsourcing offers a solution, but even this resource is not finite, and it is still incumbent on medtech firms to grasp the nettle and act now if they are to take full advantage of the MDR market opportunity.”

See full details of Maetrics’ Market Opportunity Value model here.