EU eyes easier device rules, tighter chemical protections
The European Parliament warned that medical‑device shortages are affecting patient safety and urged reforms to simplify evaluations and reduce certification burdens. ( ) Separately, the Parliament’s Employment and Social Affairs committee adopted measures to strengthen worker protections against chemical exposure. (europarl.europa.eu)
European Union lawmakers are moving in two directions at once: easier approval rules for medical devices, and stricter limits on dangerous chemicals at work. (eur-lex.europa.eu; europarl.europa.eu) On medical devices, the European Commission proposed a targeted rewrite on December 16, 2025 of the Medical Devices Regulation and the In Vitro Diagnostic Medical Devices Regulation, the rules that cover products from bandages and pacemakers to blood tests. The Commission said the aim is to make the system “easier, faster and more effective” while keeping a high level of patient safety. (ec.europa.eu; eur-lex.europa.eu) The push followed a European Parliament resolution adopted on October 23, 2024 that warned access gaps and shortages were affecting care across member states. Parliament said about 500,000 different medical devices are sold in the European Union market and called for urgent revisions to avoid critical products disappearing. (europarl.europa.eu) These rules matter because medical devices are not a niche market: the Commission says Europe has more than 38,000 medical technology companies, about 90% of them small or medium-sized businesses, employing more than 930,000 people. It valued the European medical technology market at about €170 billion in 2024. (eur-lex.europa.eu) The current framework was built after safety scandals and took effect in stages, with the Medical Devices Regulation applying from May 26, 2021 and the diagnostics regulation from May 26, 2022. Brussels has already extended transition periods, but lawmakers are still trying to cut certification bottlenecks and paperwork that manufacturers say slow supply. (ec.europa.eu; europarl.europa.eu) At the same time, the European Parliament’s Employment and Social Affairs Committee voted on April 15, 2026 to tighten worker protections against hazardous chemicals. The committee approved its position 45 votes to 0, with 10 abstentions, on the sixth revision of the carcinogens, mutagens and reprotoxic substances directive. (europarl.europa.eu) That directive is the European Union’s baseline rulebook for protecting workers from substances that can cause cancer, genetic damage or harm reproduction. It sets minimum requirements and exposure limits across the bloc. (eur-lex.europa.eu) The committee backed new exposure limits for cobalt and its inorganic compounds, polycyclic aromatic hydrocarbons and 1,4-dioxane, and it added welding fumes to the list. Lawmakers also inserted a long-term occupational exposure limit for isoprene, which is used in the chemical and rubber industries. (europarl.europa.eu) Members of Parliament also said employers should have to provide respiratory protective equipment when exposure cannot be pushed below legal limits, with limits adjusted to a worker’s body type. They added calls for regular breaks in contamination-free areas, extra protections and medical surveillance for firefighters and emergency workers, and support measures for small businesses. (europarl.europa.eu) The Parliament press service said the chemical package could prevent about 1,700 lung cancer cases and 19,000 other illnesses over 40 years, based on Commission estimates. The two tracks now move separately through the European Union’s lawmaking process, with Parliament and the Council needing to agree final texts before either set of changes becomes law. (europarl.europa.eu; ec.europa.eu)
