There's a scene in the 1984 movie "The Natural" where Roy Hobbs (played by Robert Redford) is in need of a new bat when his beloved "Wonderboy" meets it's demise. At which point he turns to the batboy and utters the immortal words "Go pick me out a winner Bobby". If you've seen the movie, you'll remember the scene. If you haven't...wait, seriously, you haven't seen "The Natural"?! Well now you have plans for the weekend.
So what pray tell does this have to do with the medical device regulations in the EU and Brexit? Honestly, not a heck of a lot, except I love that line and will use it whenever I can. Movie theater, grocery store, Christmas tree lot, you name it. And if you were counting on a UK-based entity to be an Authorised Representative (or AR) in the EU under the new regulations, it might also apply. You might be in the market for a new bat.
Let's back up. You'll recall that the United Kingdom decided to pull out of the EU in 2016, which probably would have qualified as the biggest election shocker that year were it not for their former colony besting them (once again) a few months later. Brexit set off a wave of angst around Europe and the world at large, especially for companies that use the UK as their base of operations in the European Union. Nearly two years later, there's still a lot dust settling, and the new medical device regulations are no exception.
In the MDR and IVDR, which are set to go into full effect in 2020 and 2022 respectively, there is a provision that device manufacturers, importers, distributors and ARs are considered economic operators in the EU, which means that have to be part of the EU. Based on a notice to stakeholders issued by the European Commission in January of this year, since the UK will no longer be part of the EU in 2019, then ARs operating there will not be a valid economic operator for the EU. Further, companies that import their products into the EU through the UK will also have an issue, because the UK will now be outside the lines.
This is a real problem, as approximately 50% of all the ARs in the EU work out of the UK. Not to mention a bunch of medical device companies that have their European Headquarters in the UK. If this holds, and the position expressed in the notice above stands, then economic operators throughout the UK are going to need to find a new home fast.
In fairness, most notified bodies and other economic operators in the UK have been bracing for this since Brexit. Most, if not all, are poised to shift to offices to other parts of the EU for the purposes of being an AR or other supplier. But there's an awful lot of uncertainty still around the impact of Brexit on economic operators in the medical device industry. In fact, Theresa May (British PM) only recently acknowledged that Brexit will have an impact on the UK's ability to do business with the EU, which at the very least should be cause for concern for device manufacturers based in the UK.
The good news is, there is still time to find an AR that is part of the EU. The bad news is that you should be already looking into making the switch. Like everything associated with the IVDR, there's going to be some serious stress placed on economic operators over the next couple of years, and it's likely that ARs will hit capacity before too long. Best not to wait until the lightening storm hits before you act.