On May 26, 2020, medical device manufacturers around the world face a challenging deadline: submit regulatory dossiers to Notified Bodies in compliance with the new medical device regulations (MDR) passed by the European Parliament this past May, or lose the ability to sell these devices in Europe. With just under three years to go, the clock is ticking.
Significantly, devices already approved for sale are not grandfathered in the new regulations, and the new rules for re-submitting are rigorous. For some manufacturers, this will almost certainly result in the mandatory withdrawal of devices from the European market.
In many cases, manufacturers who previously based conformity on clinical equivalence data from representative devices from other manufacturers will be required to develop supporting clinical evidence independently in order to re-establish compliance under the new regulations.
Further, rule changes will result in reclassification of some devices, and changes to requirements will force manufacturers to re-evaluate the compliance of their existing devices, naturally including devices in their development pipelines.
There are many more broad impacts arising from the new regulations, from unique device identifiers to relationships with authorized representatives. Suffice it to say that disruptive regulatory changes across all aspects of medical device manufacturing are now a certainty, and no company remains unaffected.
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Wait - haven’t we been here before?
Almost 20 years ago, the Y2K phenomenon (often called the “Millennium Bug”) was another deadline driven, high stakes occurrence that parallels the new MDR situation in many ways.
Experts realized in the early 1990’s that when the year 2000 arrived, computer systems that used two-digit years in date fields would, on New Year’s Eve at midnight, set the date to 1900 rather than 2000, with incalculable effects on any computer systems relying on date calculations.
By the time the Y2K deadline passed, over half a trillion dollars had been spent around the world to fix the problem, the majority of it by private sector organizations.
Much has been written about the lead up, resolution and evaluation of Y2K activities. Personally, I found the most interesting parts of that history were related to corporate behavior.
Faced with an imminent deadline, initial uncertainties as to the extent of the problem within each organization, concerns about the impact and cost of rectification, and worries about whether the required actions could happen in time, companies had to respond.
As one might expect, the response varied widely, but I have found a general consensus around a number of points. Interestingly, these are the ones which seem most applicable to the challenges medical device companies are currently facing as the MDR deadline approaches.
The deadline is coming, and the need for planning is obvious. However, the impact of the regulations on a specific company is often less clear at the outset – the initial gap assessment will generate surprises, with unanticipated cost and time implications.
There’s not as much time as you think
The remedy for an issue identified in the initial gap assessment can be disproportionate to the issue in terms of time and cost. For example, it may require significant lead time to conduct clinical trials or create registries to provide adequate clinical evidence under the new regulations for a specific device – better to discover that requirement early than to assume that existing clinical evidence will continue to be sufficient. Three years passes quickly.
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Prepare for the worst
The consequences of failure to meet the deadline demand a sense of urgency on the part of senior management which is not always forthcoming. The most successful strategies for getting that attention are to present the worst-case scenario (framed in economic terms). The overall challenge can then be presented in terms of specific, discrete problems, amenable to specific, discrete interventions.
The MDR deadline represents an opportunity to engage in wide-ranging and helpful house cleaning and process optimization that go beyond the steps required just to ensure compliance.
Senior management may appreciate this secondary but real benefit. Concerns and uncertainties about the budget required for transition might also be moderated by considering this factor. And it’s an argument to address retrospective conclusions that too much money had been spent – a common but largely unjustified issue after the Y2K deadline passed.
Secure resources early
The deadline represents a windfall for service providers and consultants assisting companies with MDR transition plans and implementation. Price and availability of these resources will be affected as the deadline looms closer. It is prudent to ensure that a company has employed or engaged the team required to address implementation, while those resources are more readily available.
When the dust settled on Y2K, although remediation was expensive, the crisis was really only a crisis for organizations that didn’t take the problem seriously until too late. The common sense lessons from that time apply to the MDR challenges faced today, and as proactive organizations we reap rewards from moving sooner rather than later.