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Device Firms In Non-EU Markets Using The CE Mark Should Expect Some MDR Disruption After May

 
• By Ashley Yeo

The EU Medical Device Regulation will have impacts in countries beyond the EU27, a fact that is keeping MedTech Europe’s international team very busy.

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To gauge how the EU Medical Device Regulation will affect markets outside the EU that use it as a regulatory standard, it is necessary to understand how those countries currently use the EU Medical Device Directive.

Assessing the impact of the changes that will arise in non-EU markets after 26 May is a subject that preoccupies...

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