MDR and IVDR

The transitional period for MDR will end on 26 May 2021, the “Date of Application” (DoA) of the Regulation. From that date the MDR will apply fully , leaving 1 year for IVD solutions to comply to IVDR. Is your organization ready for this shift?

Main challenges:

• Is my product portfolio touched by the new classification?
• Does the technical documentation and QMS system comply to the new rules?
• Are all economic operators involved in the product life cycle compliant and ready?

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