EU MDR Timelines: Common Questions Answered About 2017/745 Implementation Dates
If you have been looking at your upcoming device certification renewal dates or pondering a new product introduction, you may be perplexed about the timelines for MDR implementation and how to proceed. You are not alone.
Following are a few common questions our EU MDR consultants are hearing from our customers related to grandfathered devices, design changes, up-classification, and what happens to MDD-certified devices in distribution after May 2021.
In light of COVID-19, on April 24, 2020, the European Commission extended the Date of Application for EU MDR by 12 months, which means medical device companies now have until May 26, 2021 to comply with the MDR.
What are the important timelines for transitioning to the European MDR?
The new EU MDR began a transition period in May 2017. Here are some deadlines you should commit to memory.
- May 2021 – MDR date of application.
- May 2022 – EC certificates of conformity issued before May 27, 2017 expire.
- May 2024 – Required for all EC certificates issued 5 years from the issue/renewal date or 4 years from the MDR date of application (May 27, 2021), whichever comes first.
- May 2025 – Devices certified under the MDD can no longer be sold or distributed.
We plan to change our device design before early 2021. Should we pursue MDR certification?
If you plan to make more than minor changes to your device design soon, you should probably pursue MDR certification. Keep in mind that it’s already hard to get Notified Body attention so you definitely want to start working on your transition ASAP, especially if you have certificates expiring later in 2020 or early 2021.
Are any devices grandfathered under the MDR?
No, and the impact will be significant as the upcoming EU MDR will burden manufacturers whose devices were grandfathered pre-MDD (in distribution prior to 1993). Manufacturers with grandfathered MDD devices no longer maintain their grandfathered status under the MDR. If that applies to you, and you do not already have a robust quality system in place or the technical documentation required for conformity assessment, get started ASAP. We can help.
What happens with MDD-certified devices already in the distribution chain after May 2021?
Devices lawfully placed on the market pursuant to MDD/AIMDD prior to 26 May 2021, and devices placed on the market from 26 May 2021 onward, may continue to be made available on the market until May 27, 2025. If you plan to pursue a strategy of stockpiling devices as a bridge strategy to seeking MDR certification, consider the downsides associated with doing so. New restrictions exist when maintaining compliance under the current MDD EC certificate:
- Notified Bodies can no longer accept and approve notifications of “substantial” design changes. This means that the device cannot undergo important (and maybe necessary) design changes, including changes to labeling/packaging, changes to the manufacturing process, or the addition of new features and functionality.
- Devices must remain in compliance to state-of-the-art requirements, including EU-issued common specifications and recognized standards.
- New MDR postmarket surveillance (PMS) requirements must be implemented along with requirements for postmarket clinical follow-up (PMCF) or justification why PMCF is not required.
- Registration requirements for all economic operators must still be completed; in addition, it will be necessary to ensure that quality agreements are in place between the manufacturer and the Authorized Representative (AR), importer, and distributors.
Our device has been “up-classified” under the EU MDR but our current CE certificate expires before May 2021. Do we renew under the MDD?
Here’s a common example: reusable surgical instruments. Under the Medical Devices Directive (93/42/EEC), these were regulated as self-certified Class I non-sterile devices as per Annex VII. They will now be subject to a higher classification under the MDR and require Notified Body intervention. In this case, it makes sense to renew under the MDD because the design is not likely to change.
Another example: software. Some software is considered Class I under the MDD but will likely fall under Class IIa as per Rule 11 of the MDR. Unlike surgical instruments, software changes far more frequently and locking down code to delay MDR compliance can have serious competitive disadvantages. Companies in this situation will want to conduct an MDR gap analysis right away. We can help you with that.
The MDR will also affect devices that have no intended medical purpose, as they are now included in Annex XVI of the MDR. Products once considered borderline or outside the MDD purview are now medical devices or fall under a new classification. The new classification rules are a step toward an alignment of the EU and US classifications. You can check if any of your devices have shifted into a higher classification under the expanded classification rules included in MDR Annex VIII.
The smart MDR strategy? Conduct a gap analysis and create a plan
Managing the transition from the MDD to MDR requires a lot of work, but you don’t have to tackle it all alone. Oriel STAT A MATRIX has helped dozens of companies with MDR gap assessments, CER reviews and more. We also offer an intensive MDR training course.
We would like to hear from you about your experience with the MDR transition and information you may have received from your Notified Body. Please email us at email@example.com