The Medical Device Coordination Group (MDCG) has released guidance "Application of MDR requirements to ‘legacy devices’ and to devices placed on the market prior to 26 May 2021"addressing the application of the Medical Devices Regulation (MDR) requirements to legacy devices and devices that were placed on the market before May 26, 2021, in accordance with Directives 90/385/EEC and 93/42/EEC. This guidance provides clarification on how these devices should be managed under the current MDR framework, especially regarding post-market surveillance, regulatory obligations, and transitional provisions.
MDR devices are those that are placed on the market or put into service as being in conformity with the MDR other than ‘legacy devices’.Devices considered legacy are those that, according to Article 120(3) of the MDR, are placed on the market or put into service after the DoA of the MDR and before 31 December 2027 or 31 December 2028 if the conditions set forth in Article 120(3c) of the MDR are met.
A device that meets the requirements for class I under Directive 93/42/EEC (MDD), that was issued an EC declaration of conformity before 26 May 2021, and for which a notified body is required to conduct the conformity assessment under the MDR; devices covered by a valid EC certificate issued prior to 26 May 2021 under Directive 90/385/EEC (AIMDD) or MDD.
‘Old’ devices are those devices that were placed on the market or put into service 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. MDR devices are those that are placed on the market or put into service as being in conformity with the MDR other than ‘legacy devices’.
This guidance provides updated guidance as regards the applicability of MDR requirements to ‘legacy devices’ and ‘old’ devices, taking into consideration the amendments to the MDR transitional provisions. An annex consists of a non-exhaustive table illustrating whether or not MDR requirements apply to legacy devices.
Legacy devices, although certified under previous Directives, must adhere to certain MDR obligations. The guidance specifies which MDR requirements apply to these devices, including responsibilities around post-market surveillance, vigilance, and market monitoring. This ensures that legacy devices comply with updated regulatory standards to maintain safety and performance in the EU market.
Certificates issued under the Medical Devices Directive (MDD) and Active Implantable Medical Devices Directive (AIMDD) are valid until their expiration dates, provided they do not exceed May 26, 2024. This extension allows legacy devices additional time to transition under MDR requirements, permitting continued market presence while companies prepare for full MDR compliance.
For the full guidance document, click this LINK.
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