MDR: EU introduces a more flexible regulatory framework for well-established technologies

With the publication of Commission Delegated Regulations (EU) 2026/1359 and 2026/1451, the European Commission has introduced targeted amendments to the Medical Devices Regulation (MDR), adopting a more proportionate regulatory approach for medical devices with well-established use.

The Life Sciences & IP Litigation team at MFA Legal & Tech has analysed the new legislation and its implications for the sector.

Key takeaways:

• Conformity assessment: Expansion of the exemptions from the technical documentation assessment requirements for certain Class IIb implantable medical devices.
• Clinical investigations: Broader exemptions from clinical investigation requirements for specific implantable and Class III medical devices where sufficient clinical evidence is available.
• Market access: Greater regulatory flexibility burden for well-established technologies, enabling faster access to the market and a more efficient allocation of resources by competent authorities and notified bodies.

The new Delegated Regulations are directly applicable in all EU Member States and will enter into force this week, on 19 July 2026.