On the 5 May last year the new European Union Medical Device Regulation (MDR) was published in the Official Journal of the European Union.
The new regulation is associated with a three-year transition period following its publication and, therefore, will enter fully into force in 2020. After this date it will no longer be possible to put a new medical device on the market.
So now we are a year into the transition period. Let’s look at exactly how the industry is coping.
No one at a high-enough level within the EC is acknowledging that an extension to comply is necessary, therefore delaying further will only create more complications at the end of the transition period
First and foremost, in my opinion, it is hard to believe that everything will get done in the set three-year transition period.
The extended EC certificate validity period, coupled with the time it is taking to re-designate the various Notified Bodies (NBs), surely means that a timeline extension has to be inevitable.
All that said, the European Commission (EC) has openly disclosed that it is not prepared to go down this route, presumably as it could lead to the industry taking its foot off the accelerator.
Since the MDR has been released there has been growing concern that NBs are being pushed to their full capacity, which could cause delayed MDR compliance for manufacturers.
The increased pressure on NBs originates from recent safety issues being highly publicised (a strong influencer for the evolution of the MDR) meaning NBs themselves are to come under significant pressure from their respective Competent Authorities in order to heighten scrutiny of their medical device manufacturers.
There has also been a significant decrease in the number of NBs across Europe and with the MDR adding pressure it has been anticipated that there will be an over demand for their services.
Interestingly though, quite a few NBs have commented that the industry as a whole has been slow to begin the work for the MDR transition, meaning that currently the NBs are not yet responsible for any bottlenecks; although this does not mean to say that this won’t be an issue in the future.
The reason behind the slow uptake from manufacturers could be due to the fact that they are still battling with the ISO 13485:2016 as well as MDSAP (the Medical Device Single Audit Program), both of which have regulatory deadlines prior to the MDR.
Instead of manufacturers working to phase in these two transitions simultaneously; it would appear that the MDR has rather taken a backseat, for now at least.
Manufacturers who delay compliance with the MDR are going to have slim pickings when it comes to sourcing talented resources and will most likely have to pay more
There are other capacity issues that manufacturers need to be mindful of, for example the increasing lack of skilled in-house compliance professionals.
The whole life sciences industry faces a well-documented skills-gap, including clinical trial and compliance professionals. In fact, research shows that up to 80% of clinical research professionals work freelance for contract research organisations as opposed to in house.
This ultimately poses issues for the industry as a significant lack of skilled resources will be available. Therefore, manufacturers who delay compliance with the MDR are going to have slim pickings when it comes to sourcing talented resources and will most likely have to pay more, as the old adage says, where there are limited resources - prices for supply inevitably increase.
The key point that needs to be at the forefront of manufacturers' minds is that ‘hope for an extension is not a plan’.
No one at a high-enough level within the EC is acknowledging that an extension to comply is necessary, therefore delaying further will only create more complications at the end of the transition period, particularly if this is coupled with the impending ‘Brexit’ where an immense lack of clarity remains. /
For any businesses that are daunted by the new requirements, I do strongly advise seeking help from experienced compliance professionals.
I cannot stress this point enough, extension or no extension for compliance deadlines - delaying on conforming to the new MDR is no longer an option for manufacturers.