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The new EU Medical Devices Regulation (MDR) will improve patient safety

What’s new for manufacturers?

Reclassification of some devices types Reclassification of some devices types
Certification of additional product classes and rigorous clinical evidence
 
Clinical evidence icon Increased clinical evidence requirements
Expert panel, Periodic Safety Update Report (PSUR), need for premarket investigations for high risk devices
 
UDI icon Unique Device Identification (UDI)
Traceability of supply chain
 
Economic operators Economic operators
Increased manufacturer responsibility for compliance within supply chain
 
Transparency icon Increased transparency
European Database on Medical Devices (EUDAMED) and publicly available info (SSCP, PIL, etc.)
 

Are your partners MDR-ready?

Providing uninterrupted patient care could be challenging

  • Manufacturers will have a transition period to comply with the new regulations
  • Production of certain medical devices may be discontinued
  • Certification delays may lead to temporary unavailability of products for healthcare institutions

Gore is MDR-ready so you can continue improving life

Gore is ready for …

MDR conformity iconMDR conformity

  • We have been working to ensure conformity with the MDR since 2017
  • Our products hold valid CE certification – under the existing EU Medical Device Directive 93/42/EEC (MDD) – and may supply the EU market until their certification by May 2024 (Article 120)

Supply iconSeamless supply continuity

  • We are continually aligning with our Notified Body
  • Our top priority is ensuring device supply to patients in the EU and no disruption is anticipated

Question iconYour questions

  • Please send any question on MDR or Gore’s MDR strategy to our EMEA Regulatory Affairs contact, Sophie Tabutin, at stabutin@wlgore.com
Strategic partner icon

 

 GORE – A STRATEGIC PARTNER YOU CAN COUNT ON

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