The Who, What, and When of IVDR Enforcement
Are you ready for IVDR Enforcement?
We’re entering the final stretch, leading to the defining moment we’ve all anticipated for over four years at this point. No, it’s not Brexit. May 27, 2022, is the first day European authorities are fully within their rights to enforce the new regulations on In Vitro Diagnostic Medical Devices.
Like Brexit, the IVDR isn’t a new topic of conversation. Medical device manufacturers, importers, distributors, and related professionals have had nearly five years to prepare. But does that make it any less frustrating or confusing? Of course not.
The lengthy transitional period isn’t a coincidence, though. We’re moving from a market into which the majority of in vitro medical devices entered without any official certification, to a market where most devices will need to meet rigorous regulatory requirements.
Is the IVDR critical for improving patient safety? Yes. Are the IVDR regulations convoluted and tough to get straight? Also yes. So we were delighted when our friends at Greenlight Guru asked us to present the who, what, and when of IVDR enforcement at their recent summit.
What is the IVDR? What Does the Enforcement Date Mean for Me?
May 27, 2022, is the tentative date for IVDR regulations to become fully applicable and enforceable, overtaking IVDD directives as the key enforcement guidelines. Safe medical diagnostic supplies are really the foundation of any thriving healthcare system.
The EU put a ton of work into drafting the IVDR, providing specifics in many areas like carrying out clinical studies, patient safety, ethical practices, and more. When IVDR enforcement comes into effect, patients and healthcare providers can feel comfortable knowing that their in vitro diagnostic devices are validated, inspected for quality, and – most importantly – scientifically valid.
If you’re an in vitro medical diagnostic manufacturer, authorized representative, importer, or distributor doing business in the European Union, the IVDR applies to you.
Let’s say you certainly do fall under one of these categories, and that’s why you’re reading this podcast description. What will regulators look for during IVDR audits or certification processes?
- General safety and performance to ensure the devices do what they’re supposed to do without harming anyone
- Verification and validation of design and software that includes diagnostic algorithms
- Performance evaluations and official reports on the results
- More resources put into risk management planning – especially for post-market surveillance
Who’s Enforcing IVDR? What Will Happen After May 27, 2022?
The most important topic under the IVDR is quality. The smartest thing you can do is get a quality management system in place, so you’re prepared.
After May 27, 2022, EU authorities and bodies will surely crack down on anyone who neglected the deadline. From then on out, be prepared for things like:
- Scheduled and random audits
- Stringent registration and certification
- Post-market surveillance
A year might not seem like much time in the world of the medical supply market, but you may have more leeway if you fall into a few categories.
First, self-certification – one of the current processes under the existing IVDD – will now have limited applicability. Those with existing five-year CE certifications under the IVDD (Annex II) could have until May of 2024 before they’re due to fall out of legality if CE Certifications are extended before the May 27 enforcement date.
If you plan to self-certify or hold onto your five-year CE Certification, make sure your documents are marked by the May 27 enforcement date, and keep doing the background work on the IVDR.
Plus, if you’re worried you might be cutting the IVDR deadline too close, you might even qualify for an extension.
Listen to the talk to find out!
— Joanne Lebrun
P.S. Nearly every situation is unique, so if you have questions about your specific situation, let’s talk.
