Module 17 2024

05/12/2024

Chapter 15 - Transitional Arrangements

Transitional arrangements for CE marked devices (MDD) Transitional arrangements general medical devices and IVD’s that hold a valid certification/declaration of conformity to the CE standard, issued under the EU Medical Devices Directive, the EU Active Implantable Medical Device Directive or the EU in vitro Diagnostic Medical Devices Directive before the regulations take effect. The transitionary arrangement for these products which will allow, at a minimum, products to be placed on the market until either the certificate expires or for three years (for general medical devices) and five years (for IVDs) after the new regulations take effect, whichever is sooner.

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Chapter 15 - Transitional Arrangements

Two caveats that will apply to UKCA marked devices and both categories of CE marked devices covered by these arrangements are: o Devices that are subject to significant changes in design or intended purpose will be excluded from these provisions o All post-market requirements applicable to the new regulatory framework must be complied with for all products which benefit from the transitionary arrangements

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