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For a while now there have been ‘mutterings’ that the new EU regulations will make the European MedTech sector less competitive and that business will be lost to the US.  For many years, Europe has been an attractive market in terms of both size and fairly ‘light’ regulatory requirements but … patients have suffered at the hands of manufacturers who didn’t seem overly concerned about quality or where they sourced their components from.  The priority seemed to be all about profit and not the patient.

The breast implant and metal-on-metal hip replacement scandals are key examples where the ‘light’ EU regulatory framework has let the patient down.  So after many years of discussion, Europe now has harmonised regulations which place greater emphasis on clinical evaluations, quality and post-marketing vigilance.  The new EU medical device regulation will be in full force as from 27 May 2020 and the EU IVD regulation will be in full force as from 27 May 2022.

This article (https://reut.rs/31iPQ2z) discusses the divide between industry and patients.  Many in the industry are warning that the new EU medical device regulations will slow down innovation at best or deny patients access to life-saving devices at worst.  Patients, however, are saying the regulations haven’t gone far enough.

Before entrepreneurs turn their back on Europe and head over the Atlantic to the US, they should be aware that the US FDA is also increasing regulatory requirements for medical devices.  In fact, this is a global trend because of the significant numbers of devices which have harmed patients.

In the short-term, the US and other non-EU territories are likely to be more attractive but in the longer term, it is likely that the EU will gain traction again. 

Is the objective of medical device manufacturers to go for a quick win or focus on a long-term investment?  Perhaps the answer to this is: “it depends on whether profit or the patient is the key goal”.