Tuesday, 04 November, 2025
London, UK
Tuesday, November 4, 2025 7:50 PM
broken clouds 13.9°C
Condition: Broken clouds
Humidity: 88%
Wind Speed: 20.4 km/h

Biotech Act I, CV health plan and MDR simplification coming mid-December

The European Commission is set to unveil the Biotech Act I, an EU cardiovascular health plan and a simplification of the bloc’s medical devices and in vitro diagnostics rules on Dec. 16, according to the latest Commission agenda published Monday.

The first part of the Biotech Act will focus on the pharmaceutical industry and is being produced without a dedicated impact assessment. The second part — covering other biotech sectors — is expected in the third quarter of 2026.

The upcoming cardiovascular health plan — inspired by the bloc’s Beating Cancer Plan — will cover prevention, early detection and screening, treatment and management, and rehabilitation.

Meanwhile, simplification of the bloc’s medical devices and in vitro diagnostics rules comes after the regulations drove up assessment costs, caused certification delays, and led to product withdrawals from the market. Europe’s Health Commissioner Olivér Várhelyi has previously said the sector needs a “major overhaul.”

Additionally, the Commission’s agenda includes a “drugs package” comprising new rules on drug precursors and an EU Drugs Strategy and European action plan against drug trafficking — both scheduled for Dec. 3.

LP Staff Writers

Writers at Lord’s Press come from a range of professional backgrounds, including history, diplomacy, heraldry, and public administration. Many publish anonymously or under initials—a practice that reflects the publication’s long-standing emphasis on discretion and editorial objectivity. While they bring expertise in European nobility, protocol, and archival research, their role is not to opine, but to document. Their focus remains on accuracy, historical integrity, and the preservation of events and individuals whose significance might otherwise go unrecorded.

Categories

Follow

    Newsletter

    Subscribe to receive your complimentary login credentials and unlock full access to all features and stories from Lord’s Press.

    As a journal of record, Lord’s Press remains freely accessible—thanks to the enduring support of our distinguished partners and patrons. Subscribing ensures uninterrupted access to our archives, special reports, and exclusive notices.

    LP is free thanks to our Sponsors

    Privacy Overview

    Privacy & Cookie Notice

    This website uses cookies to enhance your browsing experience and to help us understand how our content is accessed and used. Cookies are small text files stored in your browser that allow us to recognise your device upon return, retain your preferences, and gather anonymised usage statistics to improve site performance.

    Under EU General Data Protection Regulation (GDPR), we process this data based on your consent. You will be prompted to accept or customise your cookie preferences when you first visit our site.

    You may adjust or withdraw your consent at any time via the cookie settings link in the website footer. For more information on how we handle your data, please refer to our full Privacy Policy