This Week in Healthcare — Brussels (#25, 2026)
Commission opens antitrust probe into Align Technology; MDR exemption lists expanded; GMO authorisations renewed; Novel food: egg membrane hydrolysate cleared; Avian influenza zones updated.
June 28, 2026 to July 04, 2026
Commission opens antitrust probe into Align Technology; MDR exemption lists expanded; GMO authorisations renewed; Novel food: egg membrane hydrolysate cleared; Avian influenza zones updated.
📋 In This Week's Newsletter
• 📅 This Week's Calendar in Brussels
• 🇪🇺 European Commission
• ⚖️ EU Legislation
• 📝 EP Motions & Questions
• ✒️ EP Committee Work
• 📚 What We're Reading This Week
This Week's Calendar in Brussels
- Committee on the Environment, Climate and Food Safety (ENVI): On July 06, the European Parliament's Committee on the Environment, Climate and Food Safety (ENVI) is scheduled to meet. Agenda includes: Amending Council Directive 98/58/EC and Directive 2009/128/EC of the European Parliament and of the Council as regards the simplification and strengthening of food and feed safety requirements, and repealing Council Directives 82/711/EEC and 85/572/EEC; Amending Regulations (EC) No 999/2001, (EC) No 1829/2003, (EC) No 1831/2003, (EC) No 852/2004, (EC) No 853/2004, (EC) No 396/2005, (EC) No 1099/2009, (EC) No 1107/2009, (EU) No 528/2012, (EU) 2017/625 as regards the simplification and strengthening of food and feed safety requirements; Chair’s announcements.
- Committee on the Environment, Climate and Food Safety (ENVI): On July 06, the European Parliament's Committee on the Environment, Climate and Food Safety (ENVI) is scheduled to meet. Agenda includes: Amending Decision (EU) 2015/1814 as regards ceasing the invalidation of allowances in the market stability reserve; Amending Decision (EU) 2015/1814 as regards the market stability reserve for the buildings, road transport and additional sector; Amending Regulation (EU) 2023/956 as regards the extension of its scope to downstream goods and anti-circumvention measures.
European Commission
Commission launches antitrust investigation into Align Technology’s dental devices
On 29 June 2026, the European Commission announced the initiation of a formal antitrust investigation into Align Technology’s practices regarding Invisalign clear aligners and iTero intra-oral scanners. The Commission is assessing potential breaches of Article 102 TFEU and Article 54 of the EEA Agreement related to the alleged tying of intra-oral scanners to clear aligner orders in the EEA. The investigation is the first formal EU competition enforcement in the medical devices sector, focusing on concerns that dental professionals were prevented from using third-party scanners with Invisalign products. The investigation will review practices since 2017, including interoperability restrictions and possible market foreclosure. There is no set deadline; further examination will continue, and the outcome is not pre-judged.
EU Legislation (Official Journal)
Regulation expands exemption list for class IIb implantable devices under the MDR
Commission Delegated Regulation (EU) 2026/1359 of 20 March 2026 amends Regulation (EU) 2017/745 to broaden the exemption from the requirement for individual assessment of technical documentation to a wider range of class IIb implantable devices. The amended Article 52(4) now includes devices such as cannulas, catheters, dental implants, and spinal posterior fixations. The changes follow consultation with the Medical Device Coordination Group and enter into force twenty days after publication in the Official Journal.
Regulation updates clinical investigation exemptions for implantable and Class III devices
Commission Delegated Regulation (EU) 2026/1451, issued on 20 March 2026, modifies Regulation (EU) 2017/745 by expanding the list of implantable and class III devices exempted from mandatory clinical investigations. The list now covers products such as reusable surgical instruments, guidewires, embolisation coils, and others identified as well-established technologies. The change aims to reflect accumulated clinical experience and maintain safety controls through obligatory clinical evaluation.
Commission authorises placing egg membrane hydrolysate on market as novel food
Commission Implementing Regulation (EU) 2026/1427 of 2 July 2026 authorises the marketing of egg membrane hydrolysate (enzymatically produced) as a novel food, amending Implementing Regulation (EU) 2017/2470. The regulation reassigns the product name from 'egg membrane collagen peptides' to 'egg membrane hydrolysate' following an EFSA safety opinion, allowing use in supplements up to 500 mg/day for adults, excluding pregnant and lactating women. Eggnovo SL holds exclusive market rights for five years after entry into force.
Commission renews GMO authorisations for maize NK603 × T25 and soybean MON 87705
Commission Implementing Decisions (EU) 2026/1417 and 2026/1419 of 29 June 2026 renew authorisations for genetically modified maize NK603 × T25 and soybean MON 87705, respectively, for food and feed uses under Regulation (EC) No 1829/2003. Both decisions follow EFSA assessments finding no new scientific evidence to alter earlier safety evaluations. The authorisation is valid for a further 10 years. Holder Bayer CropScience LLC is responsible for monitoring and reporting as required.
eur-lex.europa.eu | eur-lex.europa.eu
Authorisation granted for GMO maize DP202216 x NK603 x DAS-40278-9 and its sub-combinations
Commission Implementing Decision (EU) 2026/1443 of 29 June 2026 authorises the placing on the market of genetically modified maize DP202216 x NK603 x DAS-40278-9 and specified sub-combinations for food and feed use, excluding cultivation, under Regulation (EC) No 1829/2003. EFSA concluded these products are as safe as conventional maize and that no specific labelling beyond existing requirements is warranted.
Regulation amends technical requirements for live bivalve molluscs production
Commission Implementing Regulation (EU) 2026/1406 of 26 June 2026 modifies Implementing Regulation (EU) 2019/627, clarifying the sanitary survey requirements for classification and monitoring of bivalve mollusc production and relaying areas. Competent authorities must now conduct sanitary surveys before classifying new areas or when monitoring data indicate material environmental changes. The amendment streamlines procedures for areas already classified prior to the 2019 regulation.
Additional composite food products added to border control exemption list
Commission Delegated Regulation (EU) 2026/908 of 27 April 2026 updates Delegated Regulation (EU) 2021/630. It revises the list of shelf-stable composite products, including certain cereals and confectionery, that are exempt from official controls at border checks, provided attestation requirements under Delegated Regulation (EU) 2022/2292 are met.
Commission updates avian influenza control zones in Lithuania and Sweden
Commission Implementing Decision (EU) 2026/1426 of 25 June 2026 revises the Annex to Implementing Decision (EU) 2023/2447, adding protection and surveillance zones in Lithuania and Sweden following recent outbreaks of highly pathogenic avian influenza as reported to the Commission. The updates specify geographic boundaries and duration for control measures as required by Regulation (EU) 2016/429.
Decision allows chitosan imports from China for animal feed and food use
Commission Implementing Decision (EU) 2026/1428, adopted 1 July 2026, amends the Annex to Decision 2002/994/EC to allow the entry into the Union of chitosan (used in food and animal feed) from China without the previously required chemical safety declaration, aligning requirements with those for glucosamine.
EP Motions & Questions
ENVI motions for resolutions on GMO authorisations: soybean MON 87705, maize NK603 × T25 and DP202216 x NK603 x DAS-40278-9
Sirpa Pietikäinen (ENVI) tabled motions for resolutions on 1 July 2026 addressing the draft Commission Implementing Decisions relating to GMO authorisations for soybean MON 87705, maize NK603 × T25 and maize DP202216 x NK603 x DAS-40278-9 and its sub-combinations, pursuant to Regulation (EC) No 1829/2003.
www.europarl.europa.eu | www.europarl.europa.eu | www.europarl.europa.eu
EP Committee Work
SANT committee discusses psychosocial risks and mental health at work
On 3 July 2026, the Committee on Public Health (SANT) circulated an opinion on psychosocial risks, stress and mental health at work. Rapporteur Irena Joveva provided analysis for future policy review.
ENVI committee holds ordinary meeting on environment, climate and food safety
The Committee on the Environment, Climate and Food Safety (ENVI) convened in Brussels on 2 July 2026 for its ordinary meeting to address ongoing matters in environment and health. Key policy items included EU food safety regulations.
SANT committee focuses on recent developments in public health
On 29 June 2026, the SANT committee (Public Health) met in Brussels to discuss current topics related to environment and health. The agenda covered updates across healthcare services.
Draft report on medical device rule simplification issued by SANT
The SANT committee published a draft report dated 30 June 2026, with rapporteur Oliver Schenk, on the proposal to amend Regulations (EU) 2017/745 and 2017/746 for simplifying and reducing regulatory burdens for medical devices and IVDs. The document reviews support mechanisms to expert panels via the European Medicines Agency and updates on Union harmonisation legislation.
What We're Reading This Week
- Heatwaves push France into bitter fight over air conditioning: Soaring temperatures fuel national debate in France over energy use, public health, and adapting infrastructure to climate change.
- Health ministry changes residents' terms in new framework statute: The health ministry introduces new regulations redefining medical residents' working conditions and training structure.
- Health reform starts at home: Policymakers emphasize empowering families and communities as a foundation for successful healthcare system improvements.
- Health ministry revises residents' terms in new framework statute: New regulations alter training durations and conditions for medical residents, aiming to modernize and standardize professional requirements.
- Health professionals/workforce – Page 16: Shortages and staffing challenges among health professionals are prompting calls for urgent policy reforms to bolster the workforce.
