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.
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.
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.
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 following changes are not rated as significant, if they do not require the issuance of a new Certificate:
The following changes are rated as significant:
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.
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 Audit in April 2018 corrective actions were submitted to the authorities in August and verified during follow-up inspections in October and November 2018. Considering the evaluation by the EU Joint Audit Team and the final review by the EU MDCG we expect a designation for the EU MDR by the end of Q1 or beginning of Q2 of 2019.
The EU IVDR Joint Audit has been carried out in December 2018. We intend to provide the corrective actions by the end of Q1 of 2019 to the authorities.