When is a change in a medical technical file considered significant under Art. 120(3)MDR?
A Medical Device Manufacturer with a valid certificate issued by a Notified Body under Directive 90/385/EEC (AIMDD) or Directive 93/42/EEC (MDD) may place its devices on the market even after May 26, 2021 (date of full implementation of MDR (EU) 2017/745) and no later than May 27, 2024.
As defined by Article 120 paragraph 3 of the MDR, “A device with a certificate issued under the MDD/AIMDD may be placed on the market, provided there is no significant change in design and intended use.”
The Medical Device Coordination Group has issued a document (MDCG 2020-3) to enable Manufacturers to properly orient themselves. Within that document are a series of flow charts to help the Manufacturer determine whether or not the change they intend to make is a significant one. Where such a change does not impact the design or intended use referred to in the certificate already issued, it will be possible to notify the relevant Notified Body for approval.
If the change is not significant (insignificant change), the MDD/AIMDD CE Certificate remains valid.
If the change is significant (significant change) to be communicated to the Notified Body (ON) and results in the end of validity of the CE Certificate, the MDD/AIMDD CE Certificate loses validity. On the other hand, if the change is significant to be communicated to the Notified Body but the Notified Body approves the change, the CE Certificate remains valid.
If the change is not significant under Art.120 MDR, it may be significant under 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 ON.
If you are considering placing changes to your technical file but are not sure if such a change can be made
Thema med, “Quando le modifiche a un dispositivo vengono considerate un cambiamento significativo ai sensi dell’Articolo 120 MDR?”, 12/2021.
