Euro Roundup: EU lawmakers reach agreement on Critical Medicines Act
The European Parliament and Council have reached a provisional agreement on the Critical Medicines Act (CMA), moving proposals designed to tackle shortages of key medicines closer to law.
Officials have debated CMA since the European Commission proposed the legislation in March 2025 to improve the availability, supply, and production of critical medicines. The provisional agreement marks a major step toward finalizing the legislation, with the final steps being for the Council and the Parliament to endorse and, after legal-linguistic revision, adopt the document.
Officials have yet to publish the final text, but the Council provided an overview of the agreement. The legislation introduces an obligation for contracting authorities to apply resilience-related requirements in public procurement procedures for critical medicines to bolster supply chains. Council and Parliament negotiators also agreed on an “EU preference” approach intended to incentivize local production of critical medicines while giving contracting authorities flexibility.
The maintenance of contingency stocks, a topic that divided EU politicians during debates about CMA last year, is part of the provisional agreement. Council and Parliament negotiators built on the original proposal by stipulating that any contingency stock requirements should be transparent and respect the principles of solidarity and proportionality.
Negotiators also introduced measures allowing Member States to share information about contingency stock requirements and clarified the use of the existing voluntary solidarity mechanism. The measures enable countries to reallocate critical medicines, if needed, on a voluntary basis.
Council and Parliament negotiators expanded the scope of the legislation to include orphan products in areas including strategic projects and collaborative procurement. EURORDIS, an alliance of rare disease patient organizations, welcomed the explicit inclusion of orphan medicinal products and the facilitation of collaborative procurement.
“For countries like the Czech Republic, the ability to join forces with other Member States to procure medicines collectively is genuinely significant,” Anna Arellanesová, chair of Rare Diseases Czech Republic and deputy general secretary of EURORDIS, said.
The Commission and the European Medicines Agency (EMA) also welcomed the agreement. CMA pairs regulatory tools with targeted industrial policies to boost preparedness and support the more resilient supply of medicines, EMA said.
Press Release, EMA Statement, EURORDIS Notice, More
MHRA seeks feedback on pre-market regulatory requirements for devices and diagnostics
The Medicines and Healthcare products Regulatory Agency (MHRA) is running a consultation into new requirements for medical devices and in vitro diagnostics (IVDs) entering the Great Britain market.
MHRA is collecting data on the costs and benefits of the draft Medical Devices (Amendment) Regulations 2026. The pre-market rules are intended to accelerate access to devices and IVDs, including by relying on prior authorizations from regulators in Australia, Canada, and the US. They also aim to enhance safety through initiatives such as giving patients implant cards and making unique device identifiers compulsory.
The proposals reflect MHRA’s belief that the regulatory framework has not kept pace with advances and is no longer aligned with international best practices. Having left the European Union before the region’s medtech regulations took effect, Great Britain needed to update the Medical Devices Regulations 2002. Changes to post-market medical device rules took effect in June.
MHRA is running the pre-market consultation in parallel to a World Trade Organization (WTO) process. WTO published a notice calling for feedback on MHRA’s proposals, including the more comprehensive technical documentation requirements, strengthened requirements for devices to claim equivalence to an existing product, and the regulation of misleading or unsubstantiated claims about devices and IVDs.
The call for evidence closes on 19 June. WTO is accepting comments until 7 July. MHRA plans to adopt the regulations in December and bring them into force in June 2027, according to the WTO notice.
Press Release, MHRA Consultation, WTO Notification
Medtech industry fails to secure exemption from AI Act’s high-risk requirements
European Parliament and Council negotiators have agreed to apply the AI Act’s high-risk requirements to medical technologies, thwarting industry efforts to secure an exemption from the rules.
Trade group MedTech Europe wanted a single, sector-specific compliance pathway to apply to medical devices and IVDs. Under the proposal, the EU would use the existing medtech regulations to manage AI in medical devices and IVDs. However, negotiators opted against granting the exemption, meaning the products will be subject to parallel obligations under the medtech regulations and the AI Act.
Having failed to win an AI Act exemption, despite initial support from the Parliament, MedTech Europe has identified the ongoing revisions of the medtech regulations as the critical vehicle for addressing its outstanding concerns.
The process “offers a concrete opportunity to ensure that AI-related requirements are embedded coherently within the sectoral framework, avoiding duplication and legal uncertainty while fully preserving patient safety,” the trade group said. MedTech Europe is urging lawmakers to implement the high-risk AI requirements for medical technologies through the medtech regulations.
Notified body association Team-NB also commented on the AI Act negotiations, reminding companies that the process has no impact on the format of conformity assessment for medical device AI. Team-NB added that de novo designation of medical device notified bodies under the AI Act may be unavoidable.
Press Release, MedTech Europe, Team-NB
MHRA starts consultation into planned changes to how the UK defines gene therapies
MHRA is seeking feedback on how gene therapies are defined in UK legislation as part of reforms intended to provide clarity and consistency.
The UK’s current definition, which it developed in 2007, states gene therapy medicinal products contain “an active substance which contains or consists of a recombinant nucleic acid used in or administered to human beings with a view to regulating, repairing, replacing, adding, or deleting a genetic sequence.” Progress on manufacturing science and technology has created problems with the definition.
Synthetic nucleic acid therapies, chemically produced mRNA constructs, and novel gene editing systems do not fit clearly within the existing legislative categories, MHRA said. For example, treatments that use protein‑only editors do not meet the definition because they do not use recombinant nucleic acid.
MHRA has proposed broadening its definition to a product that “contains or consists of a substance or a combination of substances that edit a target genome in a sequence specific manner.” Cells that “have been modified in that their genome has been edited in a sequence specific manner” also meet the new definition.
The agency is seeking feedback until 22 June.
Press Release, MHRA Consultation
European Commission outlines plans to mobilize EMA to diversify supply chains
The European Commission has adopted a Global Health Resilience Initiative that gives EMA a role in diversifying global supply chains.
Supply chain diversification is one of nine flagship initiatives proposed in the document. Believing that diversified and well-integrated global supply chains help build resilience, the Commission plans to work with global partners to address concentrations of production capabilities responsible for systemic risks.
As part of the efforts, the Commission will mobilize EMA and the network of EU national regulatory authorities to support collaborative regulatory pathways. The goal is to support the development and manufacturing of key health products based on mutual interest. The Commission also plans to work with partner countries on regulatory aspects of health science, genome, and biodata repositories.
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The Swiss Agency for Therapeutic Products (Swissmedic) published guidance on clinical trials with multiple sponsors. Swissmedic Notice
