There’s a new In Vitro Diagnostic Devices Regulation (IVDR) on the way, likely to be complete at the end of the year or the beginning of next. Then of course, there will be a time lag as the text of the revised European Union (EU) regulation is prepared for distribution. For those of you in the MedDev business, this and the new Medical Devices Regulation (MDR) will definitely have an impact. Let’s take a look at some of the probable areas where you can expect change.
For the medical device industry, standards and regulations go hand in hand. This is especially true in the EU since a number of regulatory requirements can be met with the use of compliance to specific standards. So this major revision of these EU regs will require some changes to the way you do business.
First, you’ll want to know that it’s expected that the definition of IVD MD will be expanded to include any device that is a reagent, a reagent product, calibrator, control material, kit, instrument, apparatus, equipment, software or system intended to be used in vitro. This is for diagnosis (predisposition to a disease, possible reactions to a treatment, any collection of blood and/or other tissue samples). You’ll only be exempt if your products are for laboratory or research use, plus 3 other special cases.
The proposed new IVD Reg includes a new supply chain regime and expands the Eudamed database (to be renamed the MDR Eudamed). FYI: The MDR Eudamed identifier number is intended to aligned with the FDA UDI numbering scheme. It’s expected that there will be perhaps 25,000 European manufacturers in the database, as well as a similar number located outside the EU. Not only will new records be added, but old records will be retained.
Other regulatory changes for IVD include a ‘lifestyle tests’ extension when working with the concepts of purposes and prediction. Also, IVDs will be evaluated by the risk classes developed by GHTF (Global Harmonization Task Force) instead of the current list-based system. Only Class A (low risk) will be exempt from conformity assessment by a notified body (NB). This change in the risk assessment means changes in conformity assessment as well. Many IVDs that can be self certified will now need to be certified by an NB. Estimations put the change from 20% of IVDs now to 80% needing 3rd party certification when the regs come into effect.
Lastly, clinical performance studies will be required to support the CE mark under the updated IVDR as it is currently being proposed. What does this mean for you? Likely you’ll need to product significantly more clinical evidence. You’ll need to be able to prove scientific validity, as regulations move to making you fully responsible for the clinical utility of your IVDs.
When will compliance with the revised In Vitro Diagnotistic Devices Regulation be mandatory? Unlike the new MDR with it’s probable 3 year transition period, there may be a 5 year “grace” period for you to make the migration from the old regulations to the new. And of course, should the new MDR Eudamed prove a failure, the regulations to implement it will not be enforceable.
If you’d like additional help in monitoring the new directives and obtaining the supporting standards as they are released, please get in touch with us. Here at Document Center Inc. we support many medical device manufacturers. We have a range of services as well as standard sales all geared to improve your compliance for the various certification schemes your product must comply with. Use our webstore, www.document-center.com, for your purchases. Or contact our staff by phone (650-591-7600) or email (info@document-center.com) for additional assistance. Make us your Standards Experts!
