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 is the MDR expected to be implemented? 

The MDR came into force on 25 May 2017.

3. When do medical device manufacturers need to comply to the new MDR?

Manufacturers of currently approved medical devices will have a transition time of three years (until 26 May 2020) to meet the requirements of the MDR. For certain devices this transition period can be extended until 26 May 2024. However, special requirements must be met to be grant the extension.

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 and 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:

  • Changes where the MDD/AIMDD certificate needs to be updated

  • Additional claims in the intended use and/or medical indication

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 labeled 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.