FAQs - Medical Device Regulation (MDR)

Quick facts about the new MDR

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).

Discover the quick facts about the changes below.

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  may continue to be placed on the market until 26 May 2024 if they 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?

The following changes are not rated as significant, if they do not require the issuance of a new Certificate:

  • Changes not related to design or intended purpose
  • Quality system changes
  • Supplier changes such as adding a supplier of the same material fulfilling the same specifications
  • Manufacturing site changes under same legal manufacturer and following the same manufacturing requirements
  • Organisational changes
  • Exchange of components by an equivalent part to which equivalency was demonstrated
  • Material changes with materials fulfilling the same specifications
  • Limitation / reduction of the intended purpose e.g. due to PMS signals, changes to state of the art

The following changes are rated as significant:

  • Additional claims in the intended use and/or medical indication
  • Additional models or variants to an existing product family

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.


Following the MDR Joint Audit 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 Audit 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.

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 recommended 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



 Assessment of Change Notifications and Extensions for Quality systems, MDR


Technical Documentation Assessment Service


Technical Documentation Assessment Offsite 





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