Be confident of medical device market approval in the European Union
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.
From 26 May 2020, 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.
TÜV SÜD is working on an adopted position regarding the definition of “significant changes” after the date of application of the MDR. This position will be published on our website and will be sent in parallel for comments to TEAM-NB and NB-MED.
Class I reusable medical devices placed on the market after May 25, 2020, must be in compliance with the MDR. Because of changes within the MDR to the conformity assessment procedures those devices must be be labelled with the number of the Notified Body starting May 25, 2020, following the new rules.
No, you do not need to recall those devices that are placed on the market before May 26, 2020 under the MDD regime. This includes also reusable class I devices. In general, medical devices that have been lawfully placed on the market under the current MDD/AIMDD before May 25, 2020, can be made available and put into service until May 25, 2025.
MDD / AIMDD applications and submissions can be accepted until end of November 2019. Conditional upon advanced notification and planning. This includes renewals and change notifications.
Following the MDR Joint Assessment in April 2018 corrective actions were submitted to the authorities in August and verified during follow-up inspections in October and November 2018. TÜV SÜD received designation as a Notified Body for MDR on 22 May 2019.
The EU IVDR Joint Assessment has been carried out in December 2018. We intend to provide the corrective actions by the end of Q2 of 2019 to the authorities.
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
On May 5th 2017, the European commission has published a new regulation for medical devices.
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