First in a series of blogs based on a conversation about EU MDR with Karandeep Singh Badwal, moderated by Etienne Nichols as part of Greenlight Guru’s Hot Takes podcast series. Watch the full video here: https://youtu.be/Kgbmh0neJpE
Ah, MDR. The bane of every regulatory consultant’s existence.
Since its inception in 2017, EU MDR has been one of the hottest topics in the industry. While it was intended to enhance patient safety and improve the quality and performance of medical devices – or so they claim – it has also presented significant headaches, er, challenges to medical device manufacturers and regulatory agencies alike.
Many in the industry view the EU MDR as an extension of the Medical Device Directive (MDD), but with significantly stricter requirements, almost as if the MDD was given a series of “plusses,” demanding higher standards of compliance.
Now don’t get me wrong. Under MDD, there were things that manufacturers should have been doing all along but the guidances were not binding, so a lot of people just ignored them – some notified bodies included. So there were gaps in the requirements that needed to be filled.
The problem? The European Commission, in all their wisdom, simply took all these non-binding “requirements” and codified them into a new regulation, then released it without a whole lot of explanation as to what it meant or how manufacturers were expected to comply. Even now, seven years later, there remains a lack of clarity and consistency in the interpretation and implementation of the EU MDR, creating unnecessary confusion and uncertainty for manufacturers.
But the root of the problem really lies in a systemic issue within the European regulatory framework. MDR may very well have been well-intentioned, but the accountability gap between regulatory bodies, notified bodies, and manufacturers has further contributed to the challenges associated with it.
And we all know where the road paved with good intentions leads to.
Anyhoo, here are some the key changes that EU MDR introduced that are different from what was required under MDD:
- Stricter Classification Rules
- The EU MDR has stricter classification rules, particularly for software medical devices. Many software devices that were previously classified as Class I under the MDD now fall under higher-risk classifications, requiring more rigorous regulatory oversight.
- Increased Regulatory Scrutiny
- Notified bodies now have increased responsibilities and must conduct more thorough audits. This is one factor leading to longer timelines and increased costs for manufacturers (there are others that we’ll get into later).
- Enhanced Clinical Evidence Requirements
- The EU MDR mandates more robust clinical evidence, especially for high-risk devices. This can be a significant challenge for manufacturers, particularly for innovative devices. And with 75% of technical file submissions still being reported as incomplete, there is an obvious need for more clarity on the expectations.
- Strengthened Post-Market Surveillance:
- The EU MDR places greater emphasis on post-market surveillance, requiring manufacturers to continuously monitor the safety and performance of their devices. This is not a bad thing. (Remember the PIP scandal, y’all?)
All good things, yes?
On the flip side, stricter regulations and increased scrutiny from notified bodies have led to higher costs, longer timelines, and supply chain disruptions for medical device manufacturers. The more rigorous regulatory processes have delayed product development and market entry, while the increased regulatory burden has strained resources and potentially impacted the availability of medical devices.
Definitely not good.
But despite these challenges, EU MDR DOES present some opportunities for manufacturers, if you can see past the roadblocks to what can lie ahead.
Stricter regulations can help to improve patient safety by ensuring that only high-quality, safe, and effective medical devices reach the market. The increased focus on clinical evidence can drive innovation by encouraging manufacturers to develop cutting-edge medical technologies. And compliance with the EU MDR can facilitate market access in other regions that adopt similar regulatory standards.
Unfortunately, the EU market is no longer going to work for everyone: https://leanraqa.com/sell-your-product-in-europe/
It’s a bit of a mess. I actually compared EU MDR to the Umbrella Academy’s “cuckooblitz” once. Check it out: https://leanraqa.com/ra-services/eu-medical-device-regulation-mdr/
And stay tuned for Part 2, coming soon!
