January 4, 2023

EU MDR Timeline: Common Questions Answered About the Implementation Extension

If you are wondering about the implementation timelines for the European Medical Device Regulation (2017/745), you are not alone. Here are some common questions we hear from our clients related to grandfathered devices, design changes, up-classification, and more. Please confirm information about your device in this EU Commission document.

What are the updated EU MDR timelines?

The MDR transition period effective date (which was May 26, 2024) has been extended depending on classification or type of device.

Class I (non-sterile, non-measuring devices): May 26, 2021

Class I* (sterile, measuring, reusable surgical devices): December 31, 2028

Class IIb (non-implantable): December 31, 2028

Class IIb (implantable devices excluding well established technologies [WET] such as dental crowns, suture, staples, pins etc): December 31, 2027

Class III devices (most): December 31, 2027

Class III (custom made implantable): May 26, 2026

*Class I non-sterile, non-measuring devices must be in compliance with the MDR now. The extension does not apply to these devices.

What is the MDR “sell off” period for medical devices holding MDD certificates?

The “sell-off” period of May 27, 2025 has been removed for both EU MDR and EU IVDR. What this basically means is that EU MDD and EU IVDD-certified products can be in those distributors warehouses and sold until depleted.

Can we change our medical device design before 2027/2028?

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.

Our device has been “up-classified” under the EU MDR but our current CE certificate expires before May 2028.

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 are now subject to a higher classification under the MDR and require Notified Body intervention. In this case, most companies renewed under the MDD because the design is not likely to change.

Also, some software considered Class I under the MDD has moved to Class IIa per MDR Rule 11. 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.

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.