Be confident of medical device market approval
Be confident of medical device market approval
The EU's Medical Device Regulation (MDR) was officially published on 5 May 2017 and came into force on 25 May 2017. The MDR replaced the EU’s Medical Device Directive (93/42/EEC) and the EU’s Directive on active implantable medical devices (90/385/EEC).
Here are some frequently asked questions about the MDR and TÜV SÜD’s MDR services.
The Medical Device Regulation (MDR) replaced the EU’s original Medical Device Directive (93/42/EEC MDD) and the EU’s Directive on active implantable medical devices (90/385/EEC AIMDD).
The MDR came into force on 25 May 2017 and became applicable on 26 May 2021.
The MDR was amended in April 2020 to extend the Date of Application to 26 May 2021. As of that date, new medical devices placed in the European market must meet the requirements of the MDR. Legacy device holding a certificate issued by an EU Notified Body under either the MDD or the AIMDD, may continue to be placed on the market until 26 May 2024, provided that the device manufacturer has fulfilled specific prerequisite requirements as detailed in the MDR Article 120.
Notable changes include:
The complexity in developing new and advance medical devices, combined with the rigorous requirements embodied in the EU’s MDR, are like to make the regulatory approval process challenging for many device manufacturers. Even manufacturers of medical devices that were previously approved under the MDD or the AIMDD are not exempt from the MDRs requirements, and legacy devices still being sold on the market must be recertified in accordance with the MDR’s provisions.
Further, with the exception of Class I devices, an EU Notified Body must be involved in the approval and certification of all medical devices that fall within the scope of the MDR. Given the expanded scope of medical devices that require Notified Body review and approval, delays in the review and approval process should be anticipated. Device manufacturers are advised to consult with a Notified Body early in the product development process to plan the steps necessary to achieve timely and efficient MDR review and certification. Advanced preparation and early action are key.
The Medical Device Coordination Group (MDCG) has published MDCG 2020-3, “Guidance on significant changes regarding the transitional provision under Article 120 of the MDR with regard to devices covered by certificates according to MDD or AIMDD.” In its review of medical devices, TÜV SÜD will apply those criteria signifying “significant change in design or a significant change in the intended purpose” as detailed in the MDCG guidance.
Devices categorized under the MDD as a Class I reusable surgical instrument (Class Ir) that are subject to the provisions of the MDR 2nd Corrigendum may continue to be placed on the market until 25 May 2024. In instances where there is no significant change to a given device, it must be labelled by 26 May 2024, as detailed in Article 120 of the MDR. Until the Date of Application, significant changes to a device’s design or intended use may be initiated and/or implemented under the MDD.
No, there is no requirement to recall Class I reusable devices which are placed on the market under the MDD before the Date of Application of the MDR. In general, devices that have been lawfully placed on the market under the MDD or the AIMDD before the MDR Date of Application can be made available and put into service until 25 May 2025.
It is highly advisable to stay informed about the requirements and deadlines of the MDR. A guide on the key changes of the MDR is available here. Additionally, it is important to perform an assessment of how your current product portfolio may be impacted by the regulations.
The MDR application and the auditing and designation processes require an extensive effort on the part of Notified Bodies, creating various unexpected costs that are reflected in the pricing for relevant services. Moreover, Notified Bodies have been required to restructure their organisations and increase resources to provide relevant services, thus increasing overall costs. Finally, the MDR requires increased regulatory oversight which involves additional and regular assessment, resulting in higher total certification costs over a 5-year period.
Since receiving designation and notification as a MDR Notified Body, TÜV SÜD has received a large number of requests for MDR certification. We take our responsibility as a designated Notified Body seriously and make every possible effort to support a smooth implementation of the regulation and avoid any negative impact on the European healthcare system. It is critical that a continued supply of safe and effective medical devices is available for patients.
Due to the extensive interest in our services, TÜV SÜD has introduced an online service registration to process MDR certification requests in an efficient and timely manner. If your company would like to work with TÜV SÜD to have your medical device certified in accordance with the requirements of the MDD, or would like to request further MDR services from TÜV SÜD, please register your interest at our online portal at www.tuvsud.com/mdrenquiry.
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