With the new EU Medical Device Regulation (MDR) coming into effect in less than a year, many companies are still trying to figure out how to comply with the hope that the EU will extend the timeline.
Unfortunately, no such announcement has yet been made. In a recent memo, the European Commission recognized that as a consequence “some companies will no longer be able to sell their products in Europe.”
Imagine that posture and inflexibility from Brussels! If you live in the EU, you may be immune to big government’s lack of compassion for the average business owner.
However, for many of us, it’s surprising that the EU is taking an initiative with good intentions and turning it into something that is potentially hurtful to hard-working MedTech entities – and even worse – to patients who will no longer have access to some products that benefit them.
From a business perspective, this MDR directive and inflexibility means that if you want to reach the European market, unless you already are working with a Notified Body certified for the new EU regulations, you are most likely not going to be able to find one on time.
So, is there another option?
First, if you are not ISO 13485 Certified, this is a non-starter – you are simply not legally allowed to sell in the EU.
If you are ISO 13485 certified and have not yet started the MDR process, you may be years (and a good amount of money) away from being able to sell in the EU. So, are there options for you to consider?
One is to enter into a deal with a large company that has systems set up as well as deeper pockets to get your product certified or approved in compliance with MDR.
The deal could be a strategic alliance or a straight acquisition. If you are faced with a total stop entering the EU for the next few years, consider talking to us. Strategic alliances, commercialization, and acquisitions are our specialties.
We welcome your feedback on what moves you are undertaking to prepare for this drastic regulatory transition taking place within one of the world’s largest market economies for MedTech. And we wish you success in making the leap on time to remain competitive in this market.