On March 15, 2023, citing the impact of the COVID-19 pandemic, the lack of designated notified bodies and the associated over-capacities, and the imminent threat of significant shortages of necessary medical devices available on the market, the EU set forth Regulation 2023/607, amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices.
The Regulation extended the timelines for manufacturers to continue placing their devices on the market based on compliance to the existing Council Directives (93/42/EEC, 90/385/EEC, and 98/79/EC), while they continue the transition of their devices to the MDR (2017/745) and IVDR (2017/746). But this was not without meeting certain conditions.
Specifically, in order to benefit from the extended transition timelines, manufacturers must meet the amended article 120 of the MDR, which states that no later than May 26, 2024
- The manufacturer shall put in place a quality management system in accordance with MDR Article 10(9); and
- The manufacturer or the authorized representative must lodge a formal application with a notified body for MDR conformity assessment.
…and that no later than September 26, 2024, the notified body and the manufacturer have signed a written agreement.
Summary of timelines and devices
Devices which have a certificate that was issued in accordance with Directive 90/385/EEC or Directive 93/42/EEC and that is valid by virtue of Regulation 2023/607 may be placed on the market or put into service until the following dates:
| Device Classification | Deadline |
|---|---|
| Class III custom-made implantable devices without a certificate issued by a notified body in accordance with the conformity assessment procedure referred to in Article 52(8) | May 26, 2026 |
| Class III devices Class IIb implantable devices – except sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors | December 31, 2027 |
| Class IIb devices other than those noted above Class IIa devices Class I devices placed on the market in sterile condition or having a measuring function | December 31, 2028 |
| Devices for which the conformity assessment procedure pursuant to Directive 93/42/EEC did not require the involvement of a notified body, for which the declaration of conformity was drawn up prior to 26 May 2021 and for which the conformity assessment procedure pursuant to this Regulation requires the involvement of a notified body | December 31, 2028 |
What are the potential effects of procrastination?
- Delaying an application to a notified body would cause a manufacturer to have to go to the ‘back of the line’ in the review cycle, facing issues with conformity assessment.
- Due to current workloads and the last-minute submittals, notified bodies could be nearly or at full capacity, which will lead to them not being able to process an application prior to their cut-off deadline, and thus causing a manufacturer to lose the ability to take advantage of the extended transition timelines.
- Only devices transitioning to the MDR are the only ones that will be allowed to benefit from the longer transition timelines.
- Even with extended timelines, manufacturers are not allowed to make significant changes to the design or intended use of the devices that are currently covered by the existing Directives.
- Review of Technical Documentation is a lengthy process. The allocation of qualified resources and available time is at a premium at the notified body.
