Module 16 2022

9/2/2022

MDR Timelines

TOPICS

Source: Modified infographic from the EU Commission

The Organisation for Professionals in Regulatory Affairs

9/2/2022

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Article 120 Transitional Provision Timelines

26 May 2021 Date of Application

25 May 2017 Entry into Force

27 May 2024 MDD/AIMD 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

9/2/2022

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