Miudella, the first new hormone-free copper IUD approved in the U.S. in over 40 years, is expected to reach clinics in late 2026. Like Nexplanon, it’s available only through an FDA-required Risk Evaluation and Mitigation Strategy (REMS). Enrollment opened August 11, 2026, so providers and practices can go through the REMS certification to be ready once it’s commercially available. If you plan to offer Miudella, here’s what the Miudella REMS requires of you and your practice to order, stock, and place it.
What is Miudella?
Miudella is a copper-containing intrauterine device (IUD) that can be used for up to 3 years. The FDA is reviewing an application to extend that to up to 6 years, with a decision expected in 2027. It joins Paragard as the second copper IUD available in the U.S. For more information on Miudella, check out this Bedsider Providers article.
When will Miudella be available?
Organon expects Miudella to be commercially available in late 2026. It will be distributed to certified healthcare settings and through Organon’s specialty pharmacy network.
How do I get Miudella REMS certified?
Two REMS certifications are required before Miudella can be dispensed for insertion: one for each individual provider and a separate one for healthcare settings. Even if you are experienced with IUD placements, you still have to complete the training. Because Miudella’s inserter design and insertion instructions differ from other IUDs, the FDA included the REMS requirements to reduce complications from improper insertion.
Miudella REMS certification for individual providers:
Every provider who plans to insert Miudella must complete REMS training and certification at miudellarems.com.
- Review the Miudella Prescribing Information, including the Instructions for Use.
- Register for an account and complete the Insertion Training Program for Healthcare Providers.
- Complete the Healthcare Provider Knowledge Assessment online, or fax this completed form to 1-855-781-2610.
Unlike the Nexplanon REMS requirements for new or inactive providers, Miudella certification doesn’t include in-person practical training.
Miudella REMS certification for healthcare settings (practices, clinics, health systems):
Every practice or healthcare setting that purchases, dispenses, or administers Miudella needs its own certification, even if a provider there is already certified. Certified settings may dispense Miudella only to certified healthcare providers. To become certified, a healthcare setting must:
- Designate an authorized representative to carry out the certification process and oversee implementation and compliance with the REMS on behalf of the setting.
- Have the authorized representative register for an account, review the Healthcare Setting Guide and submit the Healthcare Setting Enrollment Form online or send the completed form by fax at 1-855-781-2610.
- Train all relevant staff involved in dispensing Miudella on the REMS requirements.
Can I be both a certified provider and my practice’s authorized representative?
Yes. You can certify as an authorized representative only, or as both a healthcare provider and an authorized representative. To serve in both roles, enroll through the healthcare provider enrollment process rather than the healthcare setting enrollment.
Is there a deadline to complete the Miudella REMS requirement?
There’s no fixed deadline because Miudella is a new product. Certification is required before your first Miudella insertion: you can’t order or place Miudella until both you and your practice are certified.
REMS enrollment opened August 11, 2026. Certifying now means your practice can offer Miudella as soon as it is available.
Do pharmacists need Miudella REMS certification?
Yes, if your pharmacy plans to dispense Miudella. Pharmacies that dispense Miudella must certify in the REMS, and only specialty pharmacies already contracted with Organon through its limited specialty pharmacy distribution network are eligible. Pharmacies within an integrated delivery network (IDN) or inpatient setting may instead be able to order and dispense Miudella by certifying as a healthcare setting. Visit the Miudella REMS Pharmacist site for additional information on pharmacy certification.
Who do I contact with questions about the Miudella REMS?
Call the Miudella REMS Coordinating Center at 1-855-337-0772 or visit miudellarems.com.
Key points
- Miudella requires two separate REMS certifications before it can be dispensed for insertion: one for each individual provider and one for each healthcare setting.
- Prior IUD experience doesn’t exempt you from training, because Miudella’s inserter design and insertion instructions differ from other IUDs.
- Provider certification is completed online at miudellarems.com and doesn’t include in-person practical training.
- Certified settings may dispense Miudella only to certified providers, and all staff involved in dispensing must be trained on the REMS requirements.
- There’s no fixed deadline, but you can’t order or place Miudella until both you and your practice are certified. Enrolling now means you can offer it as soon as it launches in late 2026.
