A Whole New World… of Regulatory Approvals

The European Union’s Medical Device Directives are getting an overhaul – and companies must adapt to survive

By Mark S. Talary

At a Glance

  • The EU’s current Medical Device Directives fall short in several important areas and are in the process of being revised
  • The new regulations will prompt better oversight of safety, ethics, performance, and harmonization in device development
  • Although still under discussion, the changes are expected to go into effect in the second quarter of 2016
  • Companies should begin adapting their processes to the new directives now to avoid being left behind

Any ophthalmologist who aspires to bring a medical device to market knows that the process is slow and arduous. It’s important for new devices to be thoroughly tested before they can be made commercially available – but historically, the regulatory environment in Europe has meant that this hasn’t always been the case – and clearly, regulatory failures can have significant consequences. To address these issues with device submissions already in their approval pipeline, the European Union are currently in the process of revising their Medical Device Directives (MDDs) in ways that will bring sweeping changes to the medical device industry and change the outlook for companies seeking approval.

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