Be confident of medical device market approval in the European Union
Be confident of medical device market approval in the European Union
Medical device manufacturers will soon be confronted with major changes in the EU's decades-old regulatory framework, which governs market access to the European Union (EU). The MDR will replace the EU's current Medical Device Directive (93/42/EEC) and the EU's Active Implantable Medical Devices Directive (90/385/EEC).
The Medical Device Regulation was officially published on May 5, 2017 and came into force on May 25, 2017. Currently approved medical device manufacturers had an initially three-year transition time to May 26, 2020 which was changed to May 26, 2021 to meet regulatory requirements. For some manufacturers, the new EU MDR provides additional time after the date of application, allowing them to place new products for a maximum of 4 more years on the market. More requirements will apply for this extended transition period. Click here to access the published MDR on the Official Journal of the European Union. The corrigenda for the MDR and IVDR have also been made public in this official journal.
The new EU MDR imposes strict demands on medical device manufacturers and the Notified Bodies whom they must involve in the approval process of medical devices other than self-declaration class I devices.
TÜV SÜD Product Service is among the world's first certification bodies to receive designation as a Notified Body for the new Medical Device Regulation by the Central Authority of the Länder for Health Protection with regard to Medicinal Products and Medical Devices (ZLG).
With more than 750 medical device professionals in more than 30 locations worldwide, we are the largest EU Notified Body globally authorized to provide certification services under the new regulation.
The EU MDR differs in several important ways from the EU’s current directives for medical devices and active implantable medical devices. The most significant changes in the regulation include:
The complex development process for most types of medical devices, combined with the need to address new regulatory requirements and obtain Notified Body approval, is likely to make the transition a complicated and time consuming process for most device manufacturers. Further, currently approved devices are not exempt from the requirements of the new regulation and will need to be re-evaluated and re-approved.
As manufacturers need to apply for an applicable conformity assessment procedure based on their product classification, a step by step information guide on each of the procedures is provided here.
Since a large number of medical devices will now require Notified Body review and approval, delays in the review and approval process by Notified Body should be expected. Therefore, it is recommended that manufacturers of currently approved devices 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 key to ensuring a smooth transition to the new requirements.
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 amendment to the MDR was published in April 2020, amending the MDR Date of Application to May 26, 2021. Since May 26, 2021, new devices must meet the requirements of the MDR in order to be placed on 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 they may continue to be placed on the market until May 26, 2024 if the manufacturer fulfills the specific prerequisite requirements of 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 May 25, 2024 applies. If following Article 120 of the MDR, there is no significant change to the device, the class Ir device must be labeled by May 26, 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 May 25, 2025.
TÜV SÜD stopped accepting limited MDD/AIMDD applications and submissions 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 (May 26, 2021) as the additional grace period until May 26, 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 organization 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 |
Hourly rate |
Audit |
290€ |
Assessment of Change Notifications and Extensions for Quality systems, MDR |
290€ |
Technical Documentation Assessment Service |
|
Technical Documentation Assessment Offsite |
390€ |
Earlier preparation for MDR/IVDR designation and ongoing implementation efforts for MDR certification services tie up resources which are involved in projects under the current legislative framework. This means that current assessment and certification decision timelines cannot be ensured and must be in most of the cases extended. Please consider this when communicating with your client manager and plan your project following the extended timelines.
TÜV SÜD is currently in a transition phase where we are shifting and preparing our systems and resources to provide services under the new legislative framework. We have had and continue to clarify open questions and implement newly published information about the MDR into our processes.
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 very 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 your request systematically in an appropriate time. In the event that your company is interested in the certification of your devices according to the Medical Device Regulation with TÜV SÜD, or would like to request further MDR services from TÜV SÜD, please contact us.
Under the MDD/AIMDD, the European Union had agreements in place with other countries like Switzerland and Turkey which provided regulations for different aspects, e.g. the EU authorized representative. Countries like Norway, Iceland and Lichtenstein belong to the EFTA countries and additional agreements are not necessary.
However, no* agreements are finalized between the European Union and Switzerland respectively with Turkey in regard to the MDR yet. Therefore, if a manufacturer from one of those non-member countries applies for MDR certification with a notified body, they are required to have the following installed till a mutual recognition is valid covering the new legislation:
* This information is accurate as of publication on January 14, 2020. Please always check the latest status regarding agreements between the EU and other non-member countries.
Comply with MDR Article 117
Learn More
Learn the need and requirements for single fault safety
Learn More
Understand the requirements outlined in Annex II and the elements that need to be included in the Technical Documentation
Learn More
Site Selector
Global
Americas
Asia
Europe
Middle East and Africa