If you are a Manufacturer of Medical Devices with a valid certificate issued by a Notified Body under Directive 90/385/EEC (AIMDD) or Directive 93/42/EEC (MDD), you can place your devices on the market even after May 26, 2021 (date of full application of MDR (EU) 2017/745) and no later than May 27, 2024.
However, as defined by Art. 120 c. 3 MDR, “A device with a certificate that was issued in accordance with Directive 90/385/EEC or Directive 93/42/EEC may be placed on the market, provided that there are no significant changes in the design and intended purpose”.
What should you do in case of changes to your Medical Device?
You will have to understand if this is a significant change in the design and purpose of the Medical Device to be communicated to the Notified Body (ref. NBOG Doc -PBG 2014 – 03).
If the change is not significant, the CE MDD / AIMDD Certificate remains valid.
If the change is significant to be communicated to the Notified Body (NB) and determines the end of the CE Certificate validity, then the CE MDD/AIMDD Certificate loses its validity. If, on the other hand, the change is significant to be communicated to the NB but the NB approves the change, the CE Certificate remains valid.
Even if the change is not significant under Art.120 MDR, it might be significant for the NBOG PBG 2014 – 03 “Guidance for manufacturers and Notified Bodies on reporting of Design Changes and Changes of the Quality System”, so the change may still need to be reported to the NB.
How to understand if changes to Medical Devices are significant or not?
To help you understand whether a change can be considered significant or not in the design or intended use of the device under Article 120, c. 3 MDR, we refer to the MDCG 2020-3 “Guidance on significant changes regarding the transitional provision under Article 120 of the MDR with regard to devices covered by certificates according to MDD or AIMDD”.
You can find below 6 Interactive Flow Charts, divided into 1 main chart and 5 sub-charts:
- Chart A – Change of the Intended Purpose.
- Chart B – Change of the Design or Performance Specification.
- Chart C – Software Change.
- Chart D – Change of a Material.
- Chart E – Change of terminal sterilization method of device or packaging design with impact to the sterilization.
Answering to a number of useful questions will help you determine whether a change can be considered significant or not. The change is considered non-significant with respect to design or intended use under Art. 120 MDR, if the answer to each question in the sub-charts leads to the result “non-significant change”, even when returning to the main chart.