Module 16 2022

9/2/2022

Important Definitions – Legacy vs. Old Devices What are Old Devices?

The missing definition is provided by the guidance document MDCG 2021-25 ( Regulation (EU) 2017/745 – application of MDR requirements to 'legacy devices' and to devices placed on the market prior to 26 May 2021 in accordance with Directives 90/385/ EEC or 93/42/EEC ): ‘ Old’ devices are those devices that were placed on the market: - before 26 May 2021 in accordance with the AIMDD or the MDD or - in accordance with the applicable rules before the Directives had entered into force . The MDCG task-force considers that MDR requirements are in principle not applicable to ‘old’ devices . However, Articles 93 to 100 MDR, which lay down rights and obligations of competent authorities with regard to market surveillance activities, apply also to ‘old’ devices.

The terminology of ‘legacy devices’ and ‘old devices’ is in line with existing MDCG guidance such as MDCG-2021-13 rev.1

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9/2/2022

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Important Definitions – Sell-Off Provision Article 120 Transitional provisions (4) for Legacy and Old Devices

Devices lawfully placed on the market pursuant to Directives 90/385/EEC and 93/42/EEC prior to 26 May 2021 , and devices placed on the market from 26 May 2021 pursuant to paragraph 3 of this Article , may continue to be made available on the market or put into service until 26 May 2025.

PMS, Market Surveillance, Vigilance, Registration of economic operators and of devices according to MDR

26 May 2021 Date of Application

27 May 2024

No more « placing on the market » of devices covered by MDD/AIMD certificates 27 May 2025

Only if no significant changes in design and intended purpose.

MDD/AIMDD «grace period » 3 years 27 May 2022

Annex IV/ 6 certificates void

all MDD/AIMD certificates void

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