2026 is set to be an important year for the European life sciences sector with the first major revision of EU medicines law in over 20 years and the publication of a draft regulation to simplify the EU Medical Devices Regulation (EU MDR) and EU In Vitro Diagnostics Regulation (EU IVDR).

The long-awaited EU Pharma Package will modernise the EU’s pharmaceutical legislative framework, support innovation and ensure the sector's resilience and competitiveness in challenging times.

Key elements of the reform

In December 2025, the European Parliament and Council reached agreement on the package of reform. Key elements include:

  • Changes to the regulatory data protection and market protection periods for innovative medicinal products
  • Safeguarding of the medicines supply chain and compulsory planning by marketing authorisation holders to prevent medicines shortages for all prescription medicines and other products deemed necessary
  • Strengthening of reporting and monitoring obligations
  • Increased speed and streamlining of processes including a shorter assessment time and the use of regulatory sandboxes

Formal adoption of the proposal and publication is expected later in 2026. After transition periods are announced, the new regime is likely to take effect in 2028 meaning manufacturers must plan quickly what changes need to be implemented.

Reform for medical devices and IVDs

Also in December 2025, the European Commission published a proposal to reform and simplify the regulatory framework for medical devices and IVDs.

The current EU MDR and EU IVDR have been heavily criticised since inception for the administrative burden they imposed on manufacturers, the delays in the system and the barriers that were being experienced by those trying to get innovative products to patients.

The draft Regulation aims to achieve faster market access, making innovative devices available to patients while ensuring a high level of safety. This will in turn enable a more competitive EU medical device sector.

The key actions to bring about these aims include:

  • Reducing administrative burden, enhancing coordination, simplifying rules and streamlining procedures and reporting obligations with medical device AI procedures being streamlined to avoid duplication
  • More proportionate and targeted requirements to make conformity assessments more balanced, especially for low and medium risk class devices and those for small patient populations
  • Support for innovation and the development of breakthrough technologies through adapted conformity assessment procedures
  • Enhanced legal certainty, predictability and cost efficiency of certification by reducing timelines, adjusting classification rules and the use of real-world evidence

Next steps

The draft will now be considered by the European institutions before final agreement and adoption so manufacturers will have to wait for the benefits this reform is anticipated to bring.