The Cuckooblitz is Coming…
… and there’s nothing we can do to stop it! A “cuckooblitz” (kugelblitz to my ‘Umbrella Academy’ purists) can wreak havoc on the space/time continuum, warping our perspective and changing life as we know it.
It can also form a massive black hole that destroys everything in its path. Pretty much sums up EU MDR, at least we think so?
You probably think the FDA makes things difficult… well, the EU Medical Device Regulation is even more challenging. Hire professionals who know how to navigate the complexities–hire leanRAQA.
Not Even the EU Wants to “EU MDR” Anymore
Extended timelines. The European Database on Medical Devices, or EUDAMED. Confusing and often changeable requirements. Brexit, Turkxit, and Swixit. Enough documentation to fill a large shipping container.
Six-figure notified body fees – and not nearly enough of them to handle the workload.
Yes, it’s really THAT bad.
Is it really any wonder that the FDA has become the regulating agency of choice for medical device manufacturers looking to bring a product to market?
Imagine if One Out of Every Two Medical Devices Just Disappeared…
That’s exactly what could happen, according to the latest TeamNB survey:
- > 85% of the devices certified under MDD or AIMDD do not have EU MDR certification
- 54% of manufacturers do not intend to transition their portfolio to EU MDR
- 15% of smaller medical device companies still don’t have a notified body
Up to 50% of medical device manufacturers could exit the EU market due to MDR. You don’t have to be one of them.
We Can’t Stop the Cuckooblitz, but we can help you survive it. Here’s how:
Clinical Evaluation Report (CER)
Regulatory Compliance
Post-Market Surveillance
Regulatory Strategy
Person Responsible for Regulatory Compliance (PRRC)
Technical Documentation
Think You’re Ready? How Many of These EU MDR Questions Can You Answer?
1. My software has been reclassified. What does that mean and where do I start?
2. My technology is long-standing and my materials are well-established. Do I really need a Clinical Evaluation Report?
3. I have ISO 13485 certification! Is that enough to sell my product?
4. My product has been in market for twenty years! Why do I need biocompatibility testing for submission now?
5. How do I get a notified body? They’re all so expensive and no one’s returning my calls!
6. What are the Quality System Transitional Requirements for EU MDR?
7. Can I assemble my technical documentation and self-certify?
8. Might they extend the EU MDR transition period again?
9. How long does it take for technical documentation review? My MDD certificate is expiring…
Don’t Try This at Home
Even if you typically handle your regulatory affairs in house, EU MDR is a beast unto itself – even with the proposed delay. This is a perfect time to ask for help.
Pick an open half hour on my calendar and we’ll chat about the best strategy for achieving EU MDR certification.
