Module 17 2024

05/12/2024

Chapter 15 - Transitional Arrangements

Transitional arrangements for UKCA marked devices This would apply to general medical devices that hold a valid certification/declaration of conformity to the UKCA standard, before the new regime takes full effect. This transitional arrangement will allow, at a minimum, products to be placed on the market until either the certificate expires or for three years after the new regulations take effect (in the case of general medical devices) or five years (in the case of IVDs), whichever is sooner.

The Organisation for Professionals in Regulatory Affairs

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Chapter 15 - Transitional Arrangements

Transitional arrangements for CE marked devices (MDR) Transitional arrangements general medical devices and IVDs that hold a valid certification/declaration of conformity to the CE standard, issued under the EU Medical Devices Regulation or the EU in vitro Diagnostic Medical Devices Regulation . The transitionary arrangement for these products will allow products to continue to be placed on the market until either the certificate expires or for five years after the new regulations take effect, whichever is sooner. This will apply even if the certification/declaration of conformity is dated after the new regulations take effect.

The Organisation for Professionals in Regulatory Affairs

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