The new article provides additional clarifications regarding specific aspects of the regulatory approach to be followed.
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The Medical Device Coordination Group (MDCG) has published a revised guidance document dedicated to the application of Regulation (EU) 2017/745 to “legacy devices” and to devices placed on the market before 26 May 2021 in line with the regulatory framework established under Directives 90/385/EEC or 93/42/EEC. The document provides an overview of the applicable regulatory requirements, as well as additional clarifications and recommendations to be taken into consideration by medical device manufacturers and other parties involved.
At the same time, provisions of the guidance are non-binding in their legal nature and could be subject to changes, should such changes be reasonably necessary to reflect corresponding amendments to the underlying legislation.
Application of MDR Requirements to Legacy Devices
Under Article 120(3d) of the MDR, requirements relating to post-market surveillance, market surveillance, vigilance, and the registration of economic operators and devices are fully applicable to legacy devices.
These obligations remain unchanged by Regulation 2023/607 and include:
- Application of relevant MDR requirements from Chapter VII.
- Determination of applicability based on the risk classification under the MDD, not the MDR.
- Consideration of active implantable devices and accessories as Class III devices during the transition period.
The extended MDR provisions enhance vigilance and market surveillance while supporting the registration of operators and devices, ensuring system coherence and safety.
Economic operators involved with legacy devices are subject to specific MDR provisions, tailored to ensure compliance with post-market and surveillance requirements.
Key obligations include:
- For Manufacturers: Adherence to Articles 10(10), (12)-(15), focusing on post-market compliance and safety measures.
- For Authorized Representatives: Compliance with Articles 11(3)(c)-(g), ensuring conformity and representation requirements are met.
- For Importers: Responsibilities under Articles 13(2), (4), (6)-(8), and (10), focusing on vigilance and documentation.
- For Distributors: Obligations outlined in Article 14(2), (4)-(6), focusing on supply chain compliance.
MDR requirements unrelated to surveillance or registration (e.g., Articles 15, 16(3)-(4), 18, and 19) generally do not apply to legacy devices unless voluntarily adopted.
Systems and Procedure Packs
Legacy systems and procedure packs fall within the scope of the MDR transitional provisions if they meet the following conditions:
- Comprise only legacy devices.
- Require notified body involvement under MDR.
- Were declared under Article 12(2) of the MDD before 26 May 2021.
According to the guidance, in these cases:
- Article 22 of the MDR does not apply.
- The transitional period ends with the highest risk-class device included in the pack.
- Packs treated as devices in their own right must meet Article 120(3)-(3d) MDR requirements for the extended transition.
Other MDR Requirements
From 26 May 2024, manufacturers of legacy devices must implement an MDR-compliant QMS as required by Article 10(9).
While full MDR compliance is not mandatory during the transitional period, manufacturers must:
- Address compliance steps to achieve safety and performance requirements progressively.
- Ensure the QMS covers legacy device-specific considerations, including gradual compliance with risk management and clinical evaluation requirements.
The notified body will assess the QMS as part of the MDR certification process, negating the need for pre-certification by 26 May 2024.
Legacy devices are exempt from the MDR Unique Device Identification (UDI) requirements. This clarification is consistent with MDCG 2019-5 and remains unchanged under Regulation 2023/607.
Verification of UDI assignments applies only where UDI is explicitly required.
Application to Old Devices
Devices placed on the market before 26 May 2021 (referred to as “old devices”) are subject to specific MDR provisions to ensure their safety and compliance:
- Serious Incident Reporting: Incidents and field safety corrective actions (FSCA) involving old devices must be reported under Article 87 of the MDR.
- Market Surveillance Activities: Competent authorities retain the right to verify old device compliance with rules effective at their time of market placement. Articles 93–100 of the MDR allow authorities to address non-compliant or unsafe devices appropriately.
Conclusion
In summary, the MDR requirements applied to legacy and old devices ensure continuity of safety, surveillance, and compliance during the transition period. While offering flexibility for legacy devices, the MDR emphasizes vigilance and progressive alignment with the updated framework. For stakeholders, adherence to these provisions is vitally important in order to maintain market access and uphold safety standards. It is clearly stated that systems, procedure packs, and economic operators must align with specific transitional requirements, ensuring readiness for full MDR compliance within the stipulated timelines.
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