The extension of MDR implementation timeline has now become reality. On March 20, 2023, the Regulation (EU) 2023/607, which amends the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), was officially published in the Official Journal of the European Union (OJEU) and went into immediate effect. The primary purpose of this amending Regulation is to address the anticipated risks of medical device shortages within the European Union (EU) due to a slower-than-expected transition from the previous medical device Directives to the MDR and IVDR.
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The driving force behind this amending Regulation and the related MDR extension timeline is the recognition of a slower-than-anticipated transition from the previous medical device Directives to the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). Recognizing the impending risks associated with this transition lag, the EU authorities acted swiftly to introduce these amendments.
Under the umbrella of this new amending Regulation, the timelines for transitioning to MDR have been extended, providing manufacturers with more time to adapt to the new regulatory landscape. In a nod to continuity, the Regulation also acknowledges the validity of previously issued certificates under the Medical Device Directive (MDD) and Active Implantable Medical Device Directive (AIMDD) for the duration of these extended timelines. This pragmatic approach allows manufacturers to maintain market access for their devices, provided they continue to adhere to the Directives’ compliance standards while simultaneously working toward full MDR compliance.
However, it is crucial to emphasize that these extended transition timelines are not universally applicable. They specifically pertain to devices in the process of transitioning to the MDR and are contingent upon meeting certain predefined conditions articulated in the Regulation. These conditions are put in place to ensure that manufacturers are actively and responsibly taking steps to migrate their products to align with the MDR requirements.
In light of these significant regulatory adjustments, it’s prudent for all stakeholders in the medical device industry to stay informed about the nuanced details of this amending Regulation (EU) 2023/607 to navigate the evolving regulatory landscape effectively. The following provides a concise overview of the key highlights from this pivotal regulatory update.
The Implications and Guidance of EU Regulation 2023/607 on Medical Devices
The European Union (EU) has instituted Regulation 2023/607, an essential legislative reform that directly affects the medical device sector. This new regulation, which incorporates and amends preceding norms, was enacted by the European Parliament and of the Council to address transitional provisions for certain medical devices, including in vitro diagnostic medical devices. This comprehensive article elaborates on the significance of this regulation for medical device manufacturers, the pivotal changes it brings to pre-existing laws, crucial deadlines, the stipulated guidance for compliance, and strategic considerations for involved stakeholders.
Regulation (EU) 2023/607 serves to amend Regulations (EU) 2017/745 and (EU) 2017/746 concerning transitional provisions for specific medical devices. It emanates from the necessity to create a smooth transition from former directives to the current regulatory framework while ensuring high standards of quality and safety for medical devices are upheld.
Key Elements of MDR timeline extension
The newly implemented amending Regulation ushers in a series of crucial changes that are set to have far-reaching implications across various categories of medical devices. These changes are particularly pertinent for manufacturers embarking on the transition journey to comply with the Medical Device Regulation (MDR). This significant development introduces nuanced transition timelines, the details of which are meticulously outlined below.
The transition timelines, delineated in the table provided, come into play when a manufacturer submits an MDR application by the 26th of May 2024. Furthermore, these timelines hinge on the manufacturer having entered into a formal written agreement with a Notified Body by the 26th of September 2024. However, it’s imperative to underscore that these timelines are contingent on meeting several other conditions, the specifics of which are elucidated in a dedicated FAQ document associated with the Regulation.
To comprehend the full scope of these transition timelines and their impact on various categories of medical devices, let’s delve deeper into the details. By doing so, we can gain a more comprehensive understanding of how this amending Regulation is poised to shape the landscape of medical device compliance in the EU.
The details of the MDR timeline extension is reported below:
| Transition timelines | Devices |
| 26 May 2026 | Class III custom-made implantable devices |
| 31 December 2027 | Devices covered by valid MDD/AIMDD Certificates (as of 2023/03/20 and that are Class III, or Class IIb implantable devices excluding well-established technologies (WET)* under MDR |
| 31 December 2028 | Devices covered by valid MDD/AIMDD Certificates (as of 2023/03/20) and that are Class IIb devices (excluding Class IIb implantable non-WET), or Class IIa devices, or Class I sterile devices or Class I devices with a measuring function; Devices that did not require Notified Body certification under the MDD and for which the declaration of conformity was drawn up prior to 26 May 2021, but now require Notified Body certification under the MDR |
The transitional provisions set forth by Regulation 2023/607 allow medical device manufacturers to continue marketing devices that meet legacy requirements until December 2028, contingent upon the class of the device. These provisions apply under the condition that manufacturers adhere to the new requirements relating to post-market surveillance, market surveillance, and the registration of economic operators and devices, among others. To extend the validity of CE certificates under the transitional provisions, manufacturers must meet specific criteria, which include timely submitting applications for conformity assessment and signing an agreement with a notified body. Let’s see these aspects in the next section of the article.
Conditions for Extending EU Certificates for General Medical Devices
The eligibility criteria for extending EU certificates for general medical devices are contingent upon one of the following conditions being met:
- Signed Agreement with a Notified Body: The manufacturer must have, before the certificate’s expiration, established a formal written agreement with a notified body for conducting the conformity assessment under the Medical Device Regulation (MDR) for the legacy device or a suitable substitute device.
- Competent Authority Derogation: Alternatively, a competent authority may grant an Article 59(1) or 97(1) derogation pertaining to the device. It’s worth noting that the availability of the extension has led to a limitation on the granting of derogations, as outlined in the Medical Device Coordination Group (MDCG) Guidance. Essentially, this limitation applies to derogations that were granted prior to March 20, 2023.
In addition to meeting one of these conditions, devices intended to be introduced into the market or put into service with the benefit of the extension must adhere to the following stipulations:
- Compliance with MDD/AIMD: These devices must remain compliant with the Medical Device Directive (MDD) or the Active Implantable Medical Device Directive (AIMD), as applicable. Manufacturers should take note that for devices benefiting from the extension, certain requirements of the MDR, such as Post-Market Surveillance (PMS) and others, have been in effect since May 26, 2021.
- Consistency in Design and Intended Purpose: Any alterations to the design or intended purpose of these devices must not be significant and should remain within the bounds of their original specifications.
- Safety and Health Considerations: The devices should not pose an unacceptable risk to the health and safety of patients, users, or any other individuals, nor should they compromise any other aspects related to public health protection.
- QMS Compliance: By May 26, 2024, the manufacturer is required to have a Quality Management System (QMS) in place that complies with the MDR. This compliance should be substantiated by the presence of the appropriate QMS documentation and should be a part of the MDR conformity assessment submission. This stage does not necessitate a full review of the application by the notified body or the submission of technical documentation. Instead, it must clearly identify the manufacturer, the devices involved, and establish a timeline for the submission of technical documentation and other necessary information.
- Written Agreement with Notified Body: No later than September 26, 2024, the manufacturer and the notified body must have entered into a formal written agreement for conducting the conformity assessment under the MDR.
These comprehensive conditions serve as the framework within which manufacturers can extend their EU certificates for general medical devices, ensuring both regulatory compliance and the continued safety and effectiveness of medical products in the market.
An updated Q&A document provides necessary clarifications on practical aspects related to Regulation 2023/607’s implementation. Stakeholders involved in the medical device industry should leverage this revised document for clear instructions on compliance. One crucial aspect of the transitional provisions is the self-declaration that manufacturers must complete, declaring their fulfillment of the extension conditions and specifying the transition period’s end date. Notified bodies are entities responsible for the assessment and certification process. Regulation 2023/607 mandates their involvement in the transition, underscoring that manufacturers must establish agreements with notified bodies for continued surveillance of the extended certificates.
Final Considerations for MDR extension
This MDR extensions brings some opportunities for Manufacturers, which will have more time to work to reach the expected compliance level under the EU MDR.
- Expanded Market Access: Manufacturers of Medical Device Directive (MDD) and Active Implantable Medical Device Directive (AIMDD)-certified devices who have proactively initiated steps toward Medical Device Regulation (MDR) compliance can benefit from extended market access.
- Dual Market Presence: Manufacturers who are certified under the MDR and whose MDD/AIMDD CE certificates remain valid are granted the opportunity to continue placing legacy devices on the market alongside their MDR-compliant products until the conclusion of the transition period.
- National Derogation Advantage: Manufacturers who secured a national derogation status as of March 20, 2023, stand to gain advantages during the transitional period.
- Enhanced Regulatory Understanding: The extension period affords manufacturers additional time to gain a more comprehensive understanding of the intricate rules and regulations, facilitating a smoother transition to achieve full MDR compliance.
Challenges Faced by Manufacturers Under this Extension:
- No Market Incentive for Non-Compliant Legacy Devices: Manufacturers of legacy devices who opt not to pursue MDR compliance do not benefit from this extension in terms of market access, potentially creating a disadvantage for non-compliant products.
- Certification Complexity: The extension of the MDR introduces complexities in the certification process that manufacturers must navigate diligently to ensure full compliance.
It is evident that this extension presents both opportunities and challenges for manufacturers, depending on their commitment to regulatory compliance and the proactive measures taken to adapt to the evolving European medical device regulatory landscape.
Notified bodies advise manufacturers not to delay their application submissions. There is an apparent risk that last-minute rushes could result in failing to pass necessary audits, leading to market access loss in the EU. Consulting firms, which specialize in regulatory compliance, can offer invaluable services to manufacturers. These services range from managing notified body relationships to supporting transition efforts and ensuring adherence to Regulation 2023/607’s prerequisites.
Conclusions
Regulation (EU) 2023/607 represents a significant shift in the EU’s approach to the regulation of medical devices, emphasizing the importance of a gradual and informed transition to the updated legislative context. Medical device manufacturers, in consolidating their steps for compliance, must employ strategic planning and utilize available resources to avert losing their standing in the critical EU market.
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