{"id":24392,"date":"2023-09-09T06:12:58","date_gmt":"2023-09-09T10:12:58","guid":{"rendered":"https:\/\/platohealth.ai\/mdr-extension-timeline-for-implementation\/"},"modified":"2023-09-09T10:46:38","modified_gmt":"2023-09-09T14:46:38","slug":"mdr-extension-timeline-for-implementation","status":"publish","type":"post","link":"https:\/\/platohealth.ai\/mdr-extension-timeline-for-implementation\/","title":{"rendered":"MDR Extension Timeline for Implementation","gt_translate_keys":[{"key":"rendered","format":"text"}]},"content":{"rendered":"

The extension of MDR implementation timeline has now become reality. On March 20, 2023, the Regulation (EU) 2023\/607<\/a>, 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.<\/p>\n

MDR has always been a key topic within QualityMedDev website. Important posts and discussions have been published on Strategy for regulatory Complianc<\/a>e, Combination Products<\/a>, EU MDR QMS Requirements<\/a>, and much more. <\/p>\n

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.<\/p>\n

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\u2019 compliance standards while simultaneously working toward full MDR compliance.<\/p>\n

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.<\/p>\n

In light of these significant regulatory adjustments, it\u2019s 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.<\/p>\n

Key Elements of MDR timeline extension<\/h2>\n

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.<\/p>\n

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\u2019s 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.<\/p>\n

To comprehend the full scope of these transition timelines and their impact on various categories of medical devices, let\u2019s 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.<\/p>\n

The details of the MDR timeline extension is reported below: <\/p>\n

\n\n\n\n\n\n\n\n
Transition  timelines<\/strong><\/td>\nDevices<\/strong><\/td>\n<\/tr>\n<\/thead>\n
26 May 2026<\/strong><\/td>\nClass III custom-made implantable devices <\/td>\n<\/tr>\n
31 December 2027<\/strong><\/td>\nDevices 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<\/td>\n<\/tr>\n
31 December 2028<\/strong><\/td>\nDevices 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;<\/p>\n

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<\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/figure>\n

Conditions for Extending EU Certificates for General Medical Devices<\/h2>\n

The eligibility criteria for extending EU certificates for general medical devices are contingent upon one of the following conditions being met:<\/p>\n

    \n
  1. Signed Agreement with a Notified Body<\/strong>: The manufacturer must have, before the certificate\u2019s 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.<\/li>\n
  2. Competent Authority Derogation<\/strong>: Alternatively, a competent authority may grant an Article 59(1) or 97(1) derogation pertaining to the device. It\u2019s 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.<\/li>\n<\/ol>\n

    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:<\/p>\n