The document provides an overview of the EtO regulatory status and highlights the key points to be taken into consideration by the medical device manufacturers utilizing it in their processes.
Table of content
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.
Introduction
The Regulation (EU) 2017/745 on medical devices (MDR) has undergone amendments through Regulation (EU) 2023/607, significantly impacting the transitional provisions. These amendments extend the transitional period for compliance with MDR from 26 May 2024 to either 31 December 2027 or 31 December 2028, based on the risk class of the device and subject to specific conditions.
The present document provides updated guidance on the applicability of MDR requirements to two categories of devices: “legacy devices” and “old devices”. Additionally, a non-exhaustive annex table outlines MDR requirements applicable to legacy devices.
These changes are intended to ensure a smooth transition while maintaining safety standards in the medical device industry.
Legal Provisions and Terminology
The amendments to Article 120(3) to (3e) of the MDR clarify the conditions under which certain medical devices can remain on the market or in service.
Key provisions include:
Transitional Periods for Devices:
- Class III and certain Class IIb implantable devices (excluding sutures, staples, etc.) can remain on the market until 31 December 2027.
- Class IIb (other than above), Class IIa, and Class I devices placed on the market in sterile condition or with a measuring function can remain on the market until 31 December 2028.
Devices Without Notified Body Involvement Under MDD: Devices that previously required no notified body under Directive 93/42/EEC but now require one under MDR can remain on the market until 31 December 2028 if certain conditions are met.
According to the guidance, in order for legacy devices to be allowed for marketing and use, the following conditions should be met:
- Continued compliance with Directive 90/385/EEC or Directive 93/42/EEC.
- No significant changes in design or intended purpose.
- Absence of unacceptable risk to health or safety.
- Implementation of a quality management system (QMS) by 26 May 2024.
- Lodgement of a formal application with a notified body for MDR conformity assessment by 26 May 2024 and a signed agreement with the notified body by 26 September 2024.
The applicable post-market and surveillance requirements include:
- Post-market surveillance, vigilance, and economic operator/device registration requirements under MDR apply to legacy devices in place of corresponding provisions under the old directives.
- Notified bodies involved in the certification of legacy devices must continue surveillance or transfer responsibilities as per defined agreements.
Terminology
In order to assist the parties involved, and also to ensure the correct interpretation of the relevant provisions of the applicable regulations, the document also provides definitions of the most important terms and concepts.
- Legacy Devices stand for devices placed on the market or in service after MDR’s application date (26 May 2021) but before 31 December 2027/2028, if conditions in Article 120(3c) are met. These include Class I devices under Directive 93/42/EEC, requiring MDR conformity assessment, and devices with valid EC certificates issued under Directive 90/385/EEC or Directive 93/42/EEC before 26 May 2021.
- Old Devices are devices placed on the market or in service before 26 May 2021, under the AIMDD or MDD, or previous regulatory frameworks.
- MDR Devices: Devices placed on the market as fully compliant with MDR requirements, distinct from legacy or old devices.
- “Placing on the Market”: Refers to each individual product, not the product type.
Practical Implications for Stakeholders
Manufacturers of legacy devices must meet stringent requirements to utilize the extended transitional period:
- Maintain compliance with prior directives and ensure no significant design or purpose changes.
- Implement and certify a QMS in line with MDR.
- Submit conformity assessment applications promptly and secure notified body agreements by the stipulated deadlines.
Failure to meet these requirements will result in the inability to continue placing these devices on the market under the transitional provisions.
Notified bodies must uphold their surveillance responsibilities for certified legacy devices. If surveillance responsibilities are transferred, agreements between manufacturers and both the original and new notified bodies must clearly delineate the process and scope of responsibilities.
All stakeholders in the supply chain, including importers and distributors, must adhere to MDR requirements for registration, vigilance, and market surveillance, even for legacy devices.
Key Changes in MDR Requirements for Legacy Devices
As explained by the MDCG, the MDR introduces several obligations for legacy devices, including:
- Post-Market Surveillance: Enhanced vigilance and reporting to monitor device safety and performance.
- Registration Requirements: Economic operators and devices must be registered under the MDR system.
- Quality Management Systems (QMS): QMS implementation is mandatory by 26 May 2024.
These changes ensure continuity of safety and quality during the transitional period.
Conclusion
In summary, the amendments to MDR transitional provisions provide a clear pathway for legacy and old devices to remain in service until 2027/2028. While these changes offer flexibility, they impose strict compliance conditions, emphasizing safety, quality, and surveillance. Stakeholders must act promptly to align with these requirements, ensuring uninterrupted market access and regulatory compliance. Furthermore, the guidance emphasizes the importance of a collaborative approach among manufacturers, notified bodies, and regulatory authorities to navigate the extended transitional period effectively to ensure the uninterrupted availability of critically important medical devices.
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