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UA REACH provides for one-year pre-registration phase from its entry into force on 23 January 2025 and sets the registration deadlines:

Substances		Registration deadlines
Substances above 1000 t/a, CMR category 1A/1B above t/a, substances very toxic to aquatic organisms		1 October 2026
Substances between 100 - 1000 t/a		1 June 2028
Substances between 1 - 100 t/a		1 March 2030

 The new deadlines have been extended following public consultations on a draft resolution earlier this year to provide a time buffer for companies selling on the markets with similar registration deadlines, such UK REACH, K-REACH and KKDIK.

UA REACH enables and encourages data sharing and joint registrations. It also allows for a simplified registration procedure for substances previously registered in the EU by appointing an only representative in the EU. Non-Ukrainian manufacturers and formulators must appoint an only representative to ensure regulatory compliance with legal requirements.

By introducing the pre-registration period and postponing the initial registrations deadlines, the government intends to facilitate a smooth transition towards the international safety standards. Companies, however, need to actively participate in the registration process and to ensure timely registration and market compliance.

If you are looking for any assistance, please don’t hesitate to contact our experts for international REACH registrations.

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With 160 employees, SCC Scientific Consulting Company is one of the largest private and independent regulatory consultancies in Europe, supporting clients worldwide in the registration of agrochemicals, biocides, chemicals, medical devices and other products to ensure their safe and sustainable use. With the acquisition, Ramboll now has more than 340 experts working across its Health Sciences disciplines.

The strategic acquisition strengthens Ramboll's presence in the agrochemical, chemical and pharmaceutical industries, which face the challenge of providing healthy food and products for a growing population while safeguarding biodiversity and natural resources.

"We are very excited to welcome SCC’s experts to Ramboll,” says Martina Vosteen, Global Division Director Health Sciences at Ramboll. “By combining Ramboll's global reach and strong science-based Health Sciences consulting team with SCC's extensive regulatory expertise, we can provide our clients with the best possible support in complex regulatory processes and in the implementation of their stewardship and sustainability programmes. Together, we aspire to lead the way in sustainable product safety and regulatory affairs solutions.”

SCC’s specialists expand Ramboll's Health Sciences team, which includes experts in epidemiology, toxicology, ecotoxicology, industrial hygiene and safety, exposure science, and risk assessment, paired with in-depth understanding of chemistry and economics. The team is part of Ramboll’s Environment & Health division which comprises more than 3000 experts worldwide, delivering environmental services with an emphasis on sustainable solutions.

“Ramboll and SCC are a perfect match”, says our Managing Director, Florian Pistel. "We can provide greater career opportunities for our talented employees." Managing Director Monika Hofer adds: “Ramboll provides a true global platform from which to practice and collaborate, across the Americas, Europe, and APAC. We share a common mission, purpose and culture: science-based consulting and delivering the best solutions to our clients.”

“Two major trends shaping the world today are population growth and climate change,“ says Philippa Spence, Managing Director Ramboll Environment & Health. “By 2050, the world is expected to add 3 billion more people who need access to quality and nutritious food. Maintaining the status quo in agriculture and the food value chain is not enough. Agricultural practices that feed people, are climate resilient, and are safe and sustainable are critical to meeting those challenges. SCC’s expertise in supporting seed and pesticide manufacturers with delivering safe and sustainable products, combined with the expertise and global reach of Ramboll’s Health Sciences team, strategically places us to together address these critical challenges.”

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1. Gradual phase-out of Eudamed

The Eudamed database will come into operation module by module with the entry into force of Regulation (EU) 2024/1860:

• Legacy or compliant devices must be registered within 12 months of the publication of the module functionality notice.
• The registration of certificates by notified bodies is to be done within 18 months repectively.

2. Obligation to report supply chain disruptions

According to Amendment (EU) 204/1860, manufacturers and economic operators are obliged to inform about interruption or discontinuation in supply chain 6 month before the expected interruption or discontinuation, and specify the reason.

In cases when the device is of high importance for the provision of health services, when there are no alternatives on the market and the duration of the interruption could become critical and result in serious harm or risk of serious harm to patients and/or public health in one or more Member States, the manufacturer should immediately inform the competent authorities of each Member State as well as the economic operators, healthcare institutions and healthcare professionals directly affected by an interruption or discontinuation of the supply chain according to Article 10a (3) MDR. Manufacturers of custom-made devices are excluded from this obligation. The MDCG is currently preparing a guideline to clarify when reporting is required under Article 10a MDR.

3. Extension of the transition period for in vitro diagnostics (IVDs)

The amendment concerning the IVDR transitional provision only applies to devices for which a confirmty assessment under IVDR by a notified body is required. The periods during which devices may continue to be placed on the market can be extended by two years if the manufacturer fulfild the following criteria:

• The manufacturer needs to have established a QMS system in accordance with Article 10 of the IVDR before 26 May 2025 and maintain it continuosly.
• The manufacturer should have submitted a formal application for certification to a notified bodyy. Here the deadline depends on the risk class of the device.
• The manufacturer needs to have signed a contract with the notified body cevering concerned devices.

Furthermore, devices must:

• be compliant with the directive requirements;
• not have undergone any significant changes in design or intended purpose (must be proven);
• not present a risk of health or safety for patients, users and others.

With regard to existing certificates for IVDs, devices covered by a valid certificate will continue to be monitored by notified bodies. Audits will be carried out in accordance with the IVDD until the end of the transition period.

Regulation (EU) 2024/1860 provides that notified bodies performing the conformity assessment procedure under IVDD will be responsible for the surveillance until 26 September 2025 at the latest.