What's Being Addressed

The medical device regulations in the EU (from 2017) created very strict safety rules that are causing problems: manufacturers face high costs and long approval times, devices are disappearing from the market (especially for small patient groups), and small companies are struggling to comply. The system is too complex, unpredictable, and burdensome - making it hard to get medical devices to patients who need them.

How the Problem is Being Solved

This proposal simplifies and streamlines the regulations while keeping patient safety high:

• Faster approvals: Certificates won't expire automatically anymore - instead there will be periodic reviews. For low and medium-risk devices, approval bodies will check fewer devices (just representative samples instead of every device).

• Less paperwork: Manufacturers can submit documents digitally. Reporting of safety issues gets longer deadlines (30 days instead of 15 for non-urgent incidents). Safety reports need updating less frequently.

• Support for innovation: New "fast-track" pathways for breakthrough technologies and rare-disease devices. Expert panels can give early advice to manufacturers. Countries can create "regulatory sandboxes" to test new approaches.

• Help for small companies: Reduced fees (50% discount for micro enterprises, 25% for small enterprises). Special support office at the European Medicines Agency (EMA).

• Better coordination: EMA will help coordinate between national authorities. Expert panels get expanded roles. Clearer rules for disputes about how devices should be classified.

• Simpler requirements: Some devices moved to lower risk categories (like reusable surgical instruments). Rules for clinical studies and documentation made more flexible.

What Changes as a Result

For manufacturers: Lower costs (estimated €3+ billion saved annually across the industry), faster market access, more predictable timelines, less administrative burden. Small companies get fee reductions and dedicated support.

For patients: Continued access to safe devices, fewer shortages, faster access to innovative treatments, sustained availability of devices for small patient groups.

For the system: Same high safety standards but achieved more efficiently. Better EU-wide coordination. More innovation-friendly environment while protecting public health.

Key numbers: 24 additional staff at EMA, new IT systems for shortage monitoring, certificates valid indefinitely (with periodic reviews), reduced approval body oversight (every 2 years instead of annually for low-risk situations).