News
IVF innovation: What you need to know about global regulatory pathways in 2025

By Juan A. Jiménez, founder and CEO, FindDBest IVF
In the fast-moving world of fertility innovation, building a game-changing medical device or diagnostic is only half the journey.
The other half? Getting it approved — and into the hands of those who need it.
At FinDBest IVF, we work with IVF and ART (Assisted Reproductive Technology) device manufacturers around the world to help them navigate local regulations, identify distributors, and accelerate global expansion.
Over the past few months, we’ve been breaking down country-by-country regulatory updates in a series of accessible articles.
If you’ve missed them, don’t worry.
Here’s a quick, plain-language roundup of what’s new (and what’s changing) in the major regions IVF innovators are targeting in 2025 — from the United States and Europe to Brazil, China, the Middle East, and beyond.
United States – Getting Smarter with AI and Safer with UDI
The U.S. Food and Drug Administration (FDA) remains a global gold standard. But in 2025, two updates stand out:
- Quality System Alignment: The FDA has officially aligned its quality system with ISO 13485:2016 — a widely accepted international standard. This change means U.S. and European manufacturers now speak a more “common language” when it comes to quality documentation.
- AI Oversight & UDI: The FDA’s Digital Health division now requires AI-based software (like embryo scoring tools) to include performance monitoring and retraining protocols. Also, UDI (Unique Device Identifier) submission to the FDA’s database is mandatory for traceability. This affects any embryo kit, lab platform, or culture system sold in the U.S.
Tip: If you’re developing AI software for embryo selection or any connected device, plan early for post-market data collection and ongoing validation.
China – Stricter for AI, but More Open to Global Data
China’s regulator, the National Medical Products Administration (NMPA), has doubled down on innovation — and caution.
In 2025:
- AI-powered devices are increasingly treated as Class III — the highest-risk category — especially if they influence embryo transfer decisions.
- However, NMPA now accepts overseas clinical data in some cases (if the population data is relevant), reducing the need for local trials.
Also, connected IVF devices must now integrate with China’s UDI cloud system, and submit a cybersecurity risk report as part of the approval process.
Tip: Get local regulatory advice early — and expect your AI device to be subject to the most rigorous pathway.
European Union – CE Marking Under the MDR
Europe’s Medical Device Regulation (MDR) is in full effect, and IVF-related products like culture media, incubators, embryo transfer catheters, and AI software fall under tighter scrutiny than in the past.
What’s new:
- Classifications are stricter — many IVF consumables are now Class IIb or even Class III.
- UDI and post-market reporting are mandatory.
- Software (SaMD) requires usability testing, transparency around algorithms, and cybersecurity protection.
The CE Mark still unlocks the entire European market — but earning it now takes more time, documentation, and risk management.
Tip: Plan for at least 6–12 months to get through CE marking, depending on your device class.
ASEAN – Harmonized in Theory, Fragmented in Practice

Juan A. Jiménez
The Association of Southeast Asian Nations (ASEAN) introduced the AMDD (ASEAN Medical Device Directive) to harmonize device registration — but the reality is still very country-specific.
- Each country requires separate approval, despite using the same CSDT (Common Submission Dossier Template).
- Some markets (like Singapore and Malaysia) are faster and more tech-driven.
- Others (like Indonesia or Vietnam) still require local clinical data or language-specific labeling.
Tip: Use a single ASEAN-friendly dossier and localise as needed. Don’t assume one approval unlocks all 10 markets.
Latin America – Patchwork of Rules, Rising Demand
IVF demand is rising across Brazil, Mexico, Colombia, and Argentina, but regulations vary widely:
- Brazil (ANVISA): Class III/IV devices need a local GMP certificate and may face long timelines (9–18 months).
- Mexico: Recognizes CE/FDA under its “Equivalency Pathway,” which can fast-track approvals.
- Colombia and Argentina: Local sponsor/distributor is mandatory, and digital portals are evolving.
Also, Brazil and Mexico both require product documentation in Portuguese or Spanish, and some devices must comply with local technical standards.
Tip: A smart local partner who knows the IVF space is the fastest path to compliance.
Middle East – Local Sponsors + UDI = Mandatory
Key IVF markets in the Middle East — including Saudi Arabia, UAE, Egypt, Jordan, and Qatar — continue to grow. However, nearly all require:
- A local “Authorized Representative” (AR) or license holder
- UDI labeling (especially in Saudi Arabia under the Saudi-DI program)
- In some cases, bilingual labeling (Arabic + English)
Some authorities, like the UAE’s MOHAP, offer relatively quick review times (~45 working days), while others (e.g. Egypt or Bahrain) are tightening post-market requirements and traceability rules.
Tip: Don’t underestimate the value of an experienced local sponsor — they often control the registration certificate.
Australia & New Zealand – Gold Standard and Gateway
Australia’s Therapeutic Goods Administration (TGA) is globally respected. In 2025:
- UDI is mandatory starting July 2026 for higher-risk devices.
- AI software is regulated under SaMD (Software as a Medical Device) rules.
- Post-market vigilance requirements are increasing, with hospital-level reporting becoming mandatory in 2026.
New Zealand, meanwhile, repealed its planned regulatory overhaul. That means the WAND system — which only requires notification, not approval — continues for now.
Tip: Use Australia for your “gold standard” approval; use New Zealand for speed-to-market.
What This Means for You
Whether you’re developing AI-based software, culture media, cryopreservation devices, or genetic diagnostics — regulatory strategy is now core to your go-to-market plan.
The good news? There are clear pathways. The not-so-good news? They’re all a little different.
That’s where FinDBest IVF comes in.
We help medical device manufacturers:
- Find local regulatory-savvy distributors or license holders
- That understand country-specific timelines and dossier formats
- Stay ahead of new UDI, SaMD, and post-market changes
- Expand globally, faster — with fewer surprises
Want to connect with IVF-focused partners in any of these regions?
Email us at info@findbestivf.com or visit www.findbestivf.com
Pregnancy
More than half of women with gestational diabetes face harmful stigma, research reveals

More than half of women with gestational diabetes report stigma from healthcare staff, family, friends and wider society, new research shows.
A survey of 1,800 UK women found widespread emotional distress at diagnosis of the condition, a form of high blood sugar that develops during pregnancy, with effects lasting beyond birth.
Gestational diabetes affects around one in 20 pregnancies in the UK, and the findings highlight the wider toll on women diagnosed with the condition.
The study was funded by Diabetes UK and led by researchers at King’s College London and University College Cork.
Dr Elizabeth Robertson, director of research and clinical at Diabetes UK, said: “Stigma can have a dangerous and devastating impact on pregnant women diagnosed with gestational diabetes, particularly at a time when emotions and anxieties may already be heightened.
“We know that stigma can lead to shame, isolation and poorer mental health, and may discourage people from attending healthcare appointments, potentially increasing the risk of serious complications.
“This research highlights the urgent need for better support systems, based on understanding and empathy to ensure no one feels blamed or judged during their pregnancy.”
More than two-thirds of women, 68 per cent, reported anxiety at diagnosis, while 58 per cent felt upset and 48 per cent experienced fear.
The psychological impact continued beyond birth, with 61 per cent saying the condition negatively affected their feelings about future pregnancies.
Nearly half of women, 49 per cent, felt judged for having gestational diabetes, while 47 per cent felt judged because of their body size.
More than 80 per cent felt other people did not understand gestational diabetes, and more than a third, 36 per cent, concealed their diagnosis from others.
Gestational diabetes stigma was also common in healthcare settings, with 48 per cent reporting that professionals made assumptions about their diet and exercise, and more than half, 52 per cent, feeling judged based on their blood glucose results.
Many women described a loss of control and a sense of disruption during pregnancy.
Nearly two-thirds, 64 per cent, felt they were denied a normal pregnancy, while 76 per cent reported a lack of control over their pregnancy.
More than a third, 36 per cent, felt abandoned by healthcare services after giving birth, and one in four, 25 per cent, continued to experience depression or anxiety postpartum.
Focus group participants described harmful stereotypes, including assumptions that they were ‘lazy’, had ‘poor eating habits’ or ‘lacked willpower’.
Comments from family and friends included remarks such as “should you be eating that?” and “you must have eaten too much, that’s why you have gestational diabetes.”
The researchers are calling for targeted interventions alongside structured emotional support for women during and after pregnancies affected by gestational diabetes, to improve both mental and physical health outcomes.
Professor Angus Forbes, lead researcher from King’s College London, said: “Stigma and emotional distress are far more common in women diagnosed with gestational diabetes than many realise.
“Everyday interactions, even with those who mean well, can deepen this harm, shaping women’s emotional wellbeing and the choices they feel able to make.
“It’s clear that meaningful action is needed to protect women’s mental and physical health.”
Risk factors for gestational diabetes include living with overweight or obesity, having a family history of type 2 diabetes, and being from a South Asian, Black or African Caribbean or Middle Eastern background.
Pregnancy
NIPT or NT scan? Why the 2026 evidence supports doing Both

Article produced in association with London Pregnancy Clinic
One of the most common questions in early pregnancy: NIPT or the nuchal translucency (NT) scan – do I really need both? The 2026 evidence gives a clear answer.
The two tests look at different things, and doing them together is how first-trimester screening works at its best.
This is not a debate between old and new technology. NIPT is a genuine advance in detecting chromosome abnormalities from a maternal blood sample.
The NT scan is the first detailed look at how the fetus is forming. What each sees, the other largely cannot.
What NIPT actually tells you
NIPT – non-invasive prenatal testing – analyses fragments of fetal DNA circulating in the mother’s blood. Taken from around 10 weeks, the test measures chromosome proportions to flag the common trisomies: trisomy 21 (Down syndrome), trisomy 18 (Edwards) and trisomy 13 (Patau).
Most panels include fetal sex and sex-chromosome aneuploidies. Extended NIPT adds selected microdeletion syndromes – most commonly 22q11.2 (DiGeorge syndrome) – and the newest whole-genome platforms can detect copy-number variants down to around 1 Mb across every chromosome.
What NIPT does not look at is anatomy. It tells you whether the chromosomes are numerically correct.
It cannot tell you how the heart, brain, spine, kidneys or abdominal wall are forming, because it analyses DNA, not structure.
The NHS offers NIPT as a second-line screening test, reserved for women who receive a higher-chance result from the combined test – precisely because NIPT is best understood as one part of a wider screening picture rather than the whole of it.
What the NT scan actually tells you
The NT scan is an ultrasound performed at 11 to 14 weeks that measures the nuchal translucency – a small fluid-filled space at the back of the fetal neck.
Protocols developed by the Fetal Medicine Foundation, the group that pioneered first-trimester screening under Professor Kypros Nicolaides at King’s College Hospital, combine the NT measurement with additional markers: nasal bone, ductus venosus flow, tricuspid regurgitation, and maternal serum biomarkers (PAPP-A and free β-hCG).
More importantly, the scan is the first structural assessment of the fetus.
Major anomalies already visible at 11-14 weeks include absence of the cranial vault, large body-wall defects such as omphalocele and gastroschisis, megacystis, severe cardiac defects with abnormal four-chamber views, and skeletal dysplasias.
An increased NT measurement itself – even with a completely normal chromosome result – is associated with a notable rate of structural heart defects and monogenic syndromes that NIPT cannot detect.
Why the combination outperforms either test alone
Taken together, NIPT and the NT scan give complementary coverage.
For the common trisomies, NIPT is more sensitive than the NT scan alone. Pooled data place detection of trisomy 21 above 99 per cent with a false-positive rate around 0.1 per cent.
Combined first-trimester screening without NIPT, using NT and serum markers alone, reaches approximately 90 per cent detection – and up to 95 per cent when nasal bone, ductus venosus and tricuspid flow are added – at a 3 to 5 per cent false-positive rate.
For that specific endpoint, NIPT is the more accurate test.
The NT scan picks up almost everything NIPT misses: structural anomalies, early markers of monogenic syndromes, confirmation of viability, accurate dating, twin chorionicity, and placental position.
An increased NT with a normal NIPT result shifts the clinical conversation toward syndromes like Noonan, Kabuki and the skeletal dysplasias – conditions with single-gene origins rather than chromosomal ones.
Working out which is which often requires genetic testing beyond NIPT. Carrier screening and expanded genetic panels – including those offered at Jeen Health – cover the single-gene territory that NIPT does not address.
When the combination matters most
Several patient groups have most to gain from doing both:
- Women conceiving after IVF or with donor gametes, where maternal age and fertility treatment each subtly shift risk profiles
- Women aged 35 and over, where baseline chromosomal risk is higher and soft markers are more likely
- Anyone with a previous pregnancy affected by an anomaly or loss, where reassurance matters
- Twin pregnancies, where NIPT performance depends on fetal fraction and structural assessment is more complex
- Women who have had a raised or borderline result on earlier screening markers
Chromosomes and anatomy are two separate clinical questions. Each needs its own answer.
What happens if the tests disagree
Disagreements between NIPT and the NT scan are not failures of either test – they are the reason both are done.
- NIPT low-risk, NT raised: consider monogenic syndromes, structural cardiac assessment, and early anomaly ultrasound follow-up
- NIPT higher-chance, scan normal: confirmatory diagnostic testing (CVS or amniocentesis) before any major decision
- NIPT no-call: repeat sampling, gestational age check and clinical review – a no-call itself is associated with an increased chromosomal risk
- Both abnormal: a clear indication for specialist fetal medicine review and early diagnostic testing
Professional guidance from the RCOG supports this complementary approach, emphasising that NIPT is a screening rather than a diagnostic test, and that its results are most useful when interpreted alongside ultrasound findings.
Practical guidance for 2026
The most efficient way to run both tests is in a single appointment window, between 10 and 14 weeks, with the blood sample taken first and the scan performed on the same visit.
Results typically return within 5 to 10 working days for standard NIPT panels, and same-day for the scan itself.
This is the logic behind the SMART Test at London Pregnancy Clinic – extended NIPT paired with a full first-trimester ultrasound in a single appointment, delivering both chromosomal and structural information in one visit. For most patients, it removes the false choice of picking one over the other.
The wider picture
The question of NIPT versus NT scan has a settled clinical answer in 2026: the two tests examine different aspects of the pregnancy, and the most complete first-trimester assessment uses both.
For a pregnancy a woman wants to carry with the fullest possible picture, both tests belong in the first-trimester window. The question worth asking is which clinic offers them together, with the pre- and post-test care that makes the results usable.
If you are deciding on first-trimester screening, a consultation with a fetal medicine specialist is the most useful first step.
Disclaimer: This article is produced for informational purposes only and does not constitute medical advice, diagnosis or treatment. Clinical guidance referenced reflects published NHS, Fetal Medicine Foundation and RCOG standards as at April 2026. Individual circumstances vary; readers are advised to consult a qualified healthcare professional before acting on any information in this article. This piece was produced in association with London Pregnancy Clinic, which provided background clinical information for editorial purposes. Hyperlinks to external sources are included for reference only and do not represent an endorsement of any product, service or organisation.
Diagnosis
New meta-analysis further supports low re-excisions and high placement accuracy with the Magseed marker

An independent meta-analysis from January 2026, pooling 2,117 patients and 2,176 Magseed marker placements, has reported low re-excision rates (8.2%) and low positive margins (7.6%) when the marker is used to localise non-palpable breast lesions prior to breast‑conserving surgery (BCS).
Al Darwashi et al. (2026) pooled 16 studies to evaluate safety and efficacy outcomes when the Magseed marker was used for preoperative localisation of non-palpable lesions prior to BCS.
The authors reported high placement accuracy, reliable intraoperative retrieval and low rates of positive margins, re-excisions and complications.
In a cohort cited by the review, Moreno‑Palacios et al. (2024) also observed that Magseed marker facilitates less extensive resections compared to guidewires, promising improved cosmetic outcomes while maintaining oncological efficacy.
The key findings
Low re-operation burden: Positive margins occurred in just 7.6% of cases, and only 8.2% required re-excision across the included series.
High placement accuracy: The success rate for Magseed marker placement showed 99.3% positioned within 10 mm of the lesion.
Of note, 96.6% of Magseed markers were placed within an even stricter 5 mm radius.
Reliable retrieval: The pooled intraoperative retrieval success was 99.6% for the Magseed® marker.
“This meta-analysis demonstrated Magseed as a safe and effective preoperative localisation technique for BCS in the management of selected non-palpable breast lesions.” Al Darwashi et al. (2026)
Ready to find out more about the Magseed marker and the Sentimag system?
→ Speak to a Magseed marker expert
Magseed® is a trademark of Hologic, Inc. or its subsidiaries in the United States or other countries. Intended for medical professionals and use in the U.S., UK and the EU only.
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