Module 16 2022

9/2/2022

Article 120 Transitional Provision Timelines

PMS, market surveillance, vigilance, registration of economic operators and of devices according to MDR

26 May 2021 Date of Application

25 May 2017 Entry into Force

27 May 2024 MDD/AIMMD Sunset

Transition period 3 years

27 May 2025 Sell-Off Sunset

MDD/AIMDD «grace period» 3 years

MDD/AIMDD Certificates

Annex IV/ 6 certificates void

No more « placing on the market » of devices covered by MDD/AIMD certificates

all MDD/AIMD certificates void

MDR Certificates

The Organisation for Professionals in Regulatory Affairs

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Important Definitions – Significant Changes Following Article 120 significant changes are those device modifications that are not allowed in the transition period for devices covered by certificates issued under the MDD/AIMDD.

- Significant Design Changes - Intended Use/Indications for Use

MDCG 2020-03 , that defines in detail what can be considered significant changes or not.

It is important to mention that QMS documentation shall be aligned with these requirements and the change control procedure shall include the requirements mentioned within this guidance document.

The Organisation for Professionals in Regulatory Affairs

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