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 will replace the EU’s current Medical Device Directive (93/42/EEC) and the EU’s Directive on active implantable medical devices (90/385/EEC).
Below are the frequently asked questions regarding MDR and TÜV SÜD’s MDR services.
The Medical Device Regulation (MDR) will replace the EU’s current Medical Device Directive (93/42/EEC) and the EU’s Directive on active implantable medical devices (90/385/EEC).
The MDR came into force on 25 May 2017.
The amendment to the MDR was published in April 2020, amending the MDR Date of Application to 26 May 2021. From 26 May 2021, new devices will have to meet the requirements of the MDR in order to be placed in the European market. Devices holding a certificate from a European Notified Body under either the Medical Device Directive (93/42/EEC) or the Active Implantable Medical Devices Directive (90/385/EEC) have an additional grace period and may continue to be placed on the market until 26 May 2024 if the manufacturer fulfil the specific prerequisite requirements drawn in the MDR.
Some of the key changes include:
The complex development process for medical devices, combined with the changes, make the transition a complicated and time-consuming process for most device manufacturers.
Because of these complexities, medical device manufacturers are well-advised to stay current on the progress of the MDR. Since a large number of medical devices are expected to require Notified Body review and delays in the review and certification process by the Notified Body should be expected. Manufacturers of currently certified devices are therefore advised to consult with their respective Notified Body to evaluate potential compliance issues and to develop a plan to address them promptly. Advanced preparation and early action will be the key to ensuring a smooth transition to the new requirements.
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. TÜV SÜD will be following the definition of significant changes outlined in the MDCG guidance.
If the 2nd Corrigendum to Regulation (EU) 2017/745 applies to the MDD Declaration of Conformity of a class Ir reusable surgical instrument, a grace period for continued placement into the market until 25 May 2024 applies. If following Article 120 of the MDR, there is no significant change to the device, the class Ir device must be labelled by 26 May 2024 at the latest. Significant changes such as device design or intended use changes (impacting reprocessing) may be initiated/implemented under MDD until the MDR Date of Application.
No, you do not need 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/AIMDD before the MDR Date of Application, can be made available and put into service until 25 May 2025.
TÜV SÜD will accept limited MDD / AIMDD applications and submissions until the end of October 2020. This includes renewals and change notifications. Our general recommendation would be for clients to apply for MDR certification despite the new MDR Date of Application (26 May 2021) as the additional grace period until 26 May 2024 remains unaffected.
Download our guide on the expected changes of the MDR here. You can also follow the TÜV SÜD LinkedIn showcase page for Healthcare & Medical Devices for the latest information.
In preparing for the MDR, it is important to inform yourself about the requirements and deadlines of the new 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 new regulations.
The MDR application, auditing and designation process required a large amount of effort from Notified Bodies, creating various unexpected costs that will be reflected in the future pricing for relevant services. Moreover, for the new regulation, Notified Bodies are required to restructure their organisation and increase resources to provide relevant services thus increasing production costs. MDR demands higher regulatory oversight which requires additional and regular assessment, resulting in higher total certification costs within a period of 5 years.
The following standard fees apply for the conformity assessment activities rendered out from Germany:
Audit and QM System Assessment Services
Assessment of Change Notifications and Extensions for Quality systems, MDR
Technical Documentation Assessment Service
Technical Documentation Assessment Offsite
* This information is accurate as of publication on 14 Jan 2020. Please always check the latest status regarding agreements between the EU and other non-member countries.
On May 5th 2017, the European commission has published a new regulation for medical devices.
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