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.
1. What is the Medical Device Regulation (MDR)?
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).
2. When Was the MDR implemented?
The MDR came into force on 25 May 2017.
3. When do medical device manufacturers need to comply to the new MDR?
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.
4. What are the key changes in the new MDR?
Some of the key changes include:
- Product scope expansion. The definition of medical devices and active implantable medical devices will be significantly expanded to include devices that do not have a medical intended purpose.
- Reclassification of devices according to risk, contact duration and invasiveness. The MDR will require device manufacturers to review the updated classification rules and update their technical documentation accordingly by considering the fact that class III and implantable devices will have higher clinical requirements and a regular scrutiny process.
- More rigorous clinical evidence for class III and implantable medical devices. Manufacturers will need to conduct clinical investigations in case they do not have sufficient clinical data to support the claims done on both safety and performance of a dedicated device.
- Systematic clinical evaluation of Class IIa and Class IIb medical devices. Manufacturer will need to re-prepare their clinical evaluation by considering the new wording of the regulation on when an equivalence approach and under which circumstances it is possible to justify not conducting a clinical investigation.
- More stringent documentation.
- Identification of ‘person responsible for regulatory compliance’
- Implementation of unique device identification for better traceability and recall
- More rigorous surveillance by Notified Bodies to reduce risks from unsafe devices
- Greater Scrutiny of Notified Bodies
- No “grandfathering” provisions. All currently certified medical devices and active implantable medical devices must be recertified in accordance with the new requirements.
5. What are the implications of the new MDR for medical device manufacturers?
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.
6. What is a significant change under MDR transitional provisions, article 120?
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.
7. From when does the number of the Notified Body need to appear on Class I reusable devices?
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.
8. Do I need to recall Class I reusable devices to re-label them?
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.
9. How long will TÜV SÜD accept submissions for MDD certificate renewals?
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.
10. WHAT IS THE STATUS OF TÜV SÜD’s DESIGNATION FOR MDR/IVDR?
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.
11. Where can i get more information about MDR?
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.
12. How do i prepare for the MDR?
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.
13. What is the MDR impact on certification cost?
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
|
Hourly rate
|
|
Audit
|
290€
|
|
Assessment of Change Notifications and Extensions for Quality systems, MDR
|
290€
|
|
Technical Documentation Assessment Service
|
|
|
Technical Documentation Assessment Offsite
|
390€
|
14. HOW IS THE MDD-AIMDD/MDR TRANSITION AFFECTING TÜV SÜD’s REVIEW CYCLES OF CURRENT PROJECTS?
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.
15. WHEN CAN TÜV SÜD PROVIDE MDR SERVICES?
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. Before we can start offering MDR services in regular operations, we need to clarify remaining open questions about missing systems at the EU Level and implement newly published information from authorities and stakeholders (e.g. MDR corrigendum and various MDCG Documents) into our Quality Management System. Moreover, we would like to ensure that our MDR services are not negatively impacted by the continuous new interpretations at the EU Level leading to an unreasonable use of both notified bodies and manufacturers resources. Additionally, we are still providing MDD/AIMDD services (e.g. renewals, change notifications), limiting our capacity to deliver MDR services.
During this interim period, we will have to balance the demand of MDR services and focus on the devices which must be in compliance before date of application and devices which are essential for the healthcare system in the EU. We would recommend that manufacturers consider the extended transition period for placing lawfully MDD/AIMDD certified devices on the EU Market (May 2024) by fulfilling the predefined prerequisite of the medical device regulation. Based on our current planning, we expect the transition phase to end in February 2020, enabling us to start accepting MDR applications following our standard business conditions.
16. AS A EUROPEAN MANUFACTURER FROM A NON-MEMBER COUNTRY, CAN I APPLY FOR MDR CERTIFICATION WITH TÜV SÜD? IS THERE ANYTHING I WOULD NEED TO TAKE NOTE OF?
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 authorised representative. Countries like Norway, Iceland and Lichtenstein belong to the EFTA countries and additional agreements are not necessary.
However, no* agreements are finalised 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:
- Authorised representative established within one of the EU 27 Member States
- PRRC in the EU 27 Member States which permanently available for their AR (see guidance MDCG 2019-7)
- Importer established within one of the EU 27 Member States
* This information is accurate as of publication on [Insert date here]. Please always check the latest status regarding agreements between the EU and other non-member countries.
