This Week in Healthcare — Brussels (#23, 2026)
Medical device harmonised standards updated; European Biotech Act moves in committee; Council discusses device regulation and Biotech; chemical labelling deal reached.
June 14, 2026 to June 20, 2026
Medical device harmonised standards updated; European Biotech Act moves in committee; Council discusses device regulation and Biotech; chemical labelling deal reached.
📋 In This Week's Newsletter
• 📅 This Week's Calendar in Brussels
• 🇪🇺 European Commission
• ⚖️ EU Legislation
• 🤝 EU Council
• ✒️ EP Committee Work
• 📚 What We're Reading This Week
This Week's Calendar in Brussels
- Committee on Employment and Social Affairs (EMPL): On June 22, the European Parliament's Committee on Employment and Social Affairs (EMPL) is scheduled to meet. Agenda includes: Amending Directives (EU) 2016/2341 and 2016/97 as regards the strengthening of the framework for occupational retirement provision; Amending Regulation (EU) 2019/1238 on a pan-European Personal Pension Product (PEPP); Back in Room: ANTALL 4Q1.
- Committee on the Environment, Climate and Food Safety (ENVI): On June 22, the European Parliament's Committee on the Environment, Climate and Food Safety (ENVI) is scheduled to meet. Agenda includes: ------; Amending Regulations (EC) No 1272/2008, (EC) No 1223/2009 and (EU) 2019/1009 as regards simplification of certain requirements and procedures for chemical products; Chair’s announcements.
- Committee on Employment and Social Affairs (EMPL): On June 23, the European Parliament's Committee on Employment and Social Affairs (EMPL) is scheduled to meet. Agenda includes: Chair’s announcements; Date of next meetings; Joint ECON-EMPL Economic Dialogue on the European Semester 2026.
- Committee on Employment and Social Affairs (EMPL): On June 23, the European Parliament's Committee on Employment and Social Affairs (EMPL) is scheduled to meet. Agenda includes: Amending Directives (EU) 2016/2341 and 2016/97 as regards the strengthening of the framework for occupational retirement provision; Amending Regulation (EU) 2019/1238 on a pan-European Personal Pension Product (PEPP); Back in Room: ANTALL 4Q1.
- Committee on the Environment, Climate and Food Safety (ENVI): On June 23, the European Parliament's Committee on the Environment, Climate and Food Safety (ENVI) is scheduled to meet. Agenda includes: Chair’s announcements; Date of next meetings; *** End of electronic vote ***.
- Committee on the Environment, Climate and Food Safety (ENVI): On June 23, the European Parliament's Committee on the Environment, Climate and Food Safety (ENVI) is scheduled to meet. Agenda includes: ------; Amending Regulations (EC) No 1272/2008, (EC) No 1223/2009 and (EU) 2019/1009 as regards simplification of certain requirements and procedures for chemical products; Chair’s announcements.
- Committee on the Environment, Climate and Food Safety (ENVI): On June 23, the European Parliament's Committee on the Environment, Climate and Food Safety (ENVI) is scheduled to meet. Agenda includes: Chair’s announcements; Exchange of views with Costas Kadis, Commissioner for Fisheries and Oceans, on 'The European Ocean Pact, one year after the UN Ocean Conference'.
- Committee on Public Health (SANT): On June 24, the European Parliament's Committee on Public Health (SANT) is scheduled to meet. Agenda includes: * * *; An EU cardiovascular diseases strategy; Chair’s announcements.
- Environment Council: On June 25, the EU Council's Environment Council configuration is scheduled to hold an ministerial meeting in Brussels.
- Committee on the Environment, Climate and Food Safety (ENVI): On June 25, the European Parliament's Committee on the Environment, Climate and Food Safety (ENVI) is scheduled to meet. Agenda includes: Amending Regulations (EC) No 1907/2006, (EC) No 1272/2008, (EU) No 528/2012, (EU) 2019/1021 and (EU) 2021/697 as regards defence readiness and facilitating defence investments and conditions for defence industry; Chair’s announcements; *** End of electronic vote ***.
European Commission
Commission amends medical device harmonised standards
On 17 June 2026, the European Commission adopted Implementing Decision (EU) 2026/1231, amending Decision (EU) 2021/1182. The update covers standards for the biological evaluation of medical devices, manufacturer-provided symbols, medical electrical equipment, transfusion equipment, ophthalmic optics, non-active surgical implants, washer-disinfectors, prosthetics, and sharps injury protection. The Decision incorporates CEN and CENELEC revisions, such as EN ISO 10993-23:2021/A1:2025 on in vitro models and EN ISO 15223-1:2021/A1:2025 modifying symbols regarding authorised representatives. The amendments defer the withdrawal of certain earlier standards; for example, EN ISO 15223-1:2021 will remain referenced until 15 June 2031. The measures aim for alignment with Regulation (EU) 2017/745. The Decision enters into force on publication in the Official Journal.
EU Legislation (Official Journal)
Authorisation of ‘Ecolab Glut Family’ biocidal product for medical uses
Commission Implementing Regulation (EU) 2026/1337, adopted 17 June 2026, grants Ecolab Deutschland GmbH a Union authorisation for the biocidal product family 'Ecolab Glut Family' (product-types 6, 11, and 12) under Regulation (EU) No 528/2012. Glutaraldehyde is the active substance. The authorisation follows a comparative assessment due to glutaraldehyde's classification as a candidate for substitution and is valid from 8 July 2026 until 30 June 2031. No restrictions were imposed following the comparative assessment.
Medical device symbols harmonised standard updated for IVDs
Commission Implementing Decision (EU) 2026/1313, published 17 June 2026, amends Decision (EU) 2021/1195 as regards harmonised standards for symbols supplied by medical device manufacturers, focusing on in vitro diagnostic devices. The amendment refers to EN ISO 15223-1:2021/A1:2025, introducing changes reflecting a non-region-specific EC REP symbol. The withdrawal of the previous standard is deferred until 17 June 2031 to allow adaptation.
Amendment to MRLs for major plant protection products
Commission Regulation (EU) 2026/1314, adopted 15 June 2026, updates Annexes II, III, and V to Regulation (EC) No 396/2005, adjusting maximum residue levels (MRLs) for several substances, including 1,4-dimethylnaphthalene, chlormequat, metribuzin, and triclopyr. The revised MRLs impact compound feed and may affect animal products used for medicinal or veterinary purposes. The new values apply from 6 January 2027.
EU Council
Council (EPSCO Health) debates on Biotech and medical device regulation
At the Employment, Social Policy, Health and Consumer Affairs Council (Health) meeting of 16 June 2026, ministers discussed the European Biotech Act I and the medical and in vitro devices regulation.
EP Committee Work
Draft report: European Biotech Act—health sector focus
The SANT Committee on Public Health published its draft report on the proposal for a regulation establishing a framework for strengthening EU biotechnology and biomanufacturing sectors, notably in health (European Biotech Act), amending Regulations (EC) No 178/2002, (EC) No 1394/2007, (EU) No 536/2014, (EU) 2019/6, and others. The rapporteur is Wouter BEKE.
IMCO draft opinion on medical device simplification proposal
On 16 June 2026, the IMCO Committee (rapporteur Maria GUZENINA) published a draft opinion on the proposal to amend Regulations (EU) 2017/745 and (EU) 2017/746, which seek to simplify and reduce regulatory burden for medical devices and in vitro diagnostic medical devices, and to amend rules for expert panels coordinated by the European Medicines Agency.
SANT announces hearing on digital health and advanced medical technologies
The SANT committee will hold a public hearing on 'Digital health: Preparing healthcare systems for the future' on 24 June 2026, covering Artificial Intelligence in healthcare, the European Health Data Space, biotechnology, and breakthrough medical devices. The agenda includes a review of future system preparedness and regulatory perspectives.
What We're Reading This Week
- Video. Europe looks at banning social media, and girls are most impacted: European policymakers consider banning social media platforms, raising concerns about disproportionate effects on girls' mental health and well-being.
- How is the EU tackling drug trafficking and synthetic substance use?: EU intensifies border controls, updates legal frameworks, and promotes cross-country cooperation to combat rising synthetic drug threats.
- Flatmates share a gut microbiome — even without kissing, study finds: New research shows cohabiting flatmates develop similar gut microbiomes, suggesting daily shared environments influence gut health.
- Europe's rare disease patients face a mental health care gap, survey finds: Survey reveals significant unmet mental health needs among Europe's rare disease patients, highlighting gaps in support and access to care.
- What is alpha-gal syndrome, the rare meat allergy caused by tick bites: Growing evidence links certain tick bites to alpha-gal syndrome, a condition that triggers allergic reactions to red meat.
