Impression Marketing director, Angus Long
If there is one aspect of our country that is guaranteed to unite most people, it’s the love we have for our National Health Service.
So, naturally, many people would be concerned about anything that may have a detrimental impact upon our healthcare.
Well there is a little known EU directive that may well do that. It’s called The Medical Device Regulation (MDR).
In short, any product, new or established, must now undergo an additional raft of new testing, clinical trials, documentation and independent evaluation before certification.
The MDR took effect on 25th May 2017 with a three-year transition period. This means, from 26th May 2020, it will mandatory in all EU member states.
Failure to achieve MDR certification will mean the products will not comply and thus unable to be used or marketed in the EU.
Like many things, the initial inspiration for the MDR was based on good intentions. Following the faulty PIP breast implants scandal in France (March 2010), there were calls for tighter licensing regulations for medical devices within the EU. The MDR is the outcome.
The problem is, like so many EU directives, it has been badly drafted with little understanding of how it would work in practice and the consequences upon the very vast and complex nature that is modern healthcare.
The problem is, the sheer number of manufacturers, suppliers and products is massive. All but the very largest suppliers are struggling to meet the deadline as they simply do not have the resources to undertake the required red tape to achieve approval.
The vast majority of these products have been used for many years with no clinical concerns whatsoever offering many clinical benefits to patients. It is estimated, due to the MDR, it may cost the NHS an extra 10-15% to procure its medical devices.
This is bad enough, but because there are so few regulatory authorities, with limited qualified staff to implement the MDR, there is the very real risk that a great number of hospitals and healthcare establishments across the county will be unable to provide vital operations or perform procedures as the equipment and instruments they have won’t be MDR compliant.
With the deadline is just nine months away the idea that the NHS many grind to a halt really is a project fear.