July 6, 2021

EU MDR Critical Component Changes to MDD-Installed Devices

If changing the supplier of a critical component that will be, or could be, subsequently used for component replacement in devices already installed (i.e., already put into service) in the Union prior to 26 May 2021 under an MDD Declaration of Conformity (DoC) and Notified Body (NB) certificate, then the most ideal regulatory scenario is to be able to conclude that such a change is not a “significant change”.  If that argument can be sustained, then it eliminates much of the grappling required by the EU MDR.  I explain further below where I lay out a basic framework of the regulatory strategy path I would follow:

1. First remember that NB notification about device changes is subject to the particulars of the agreed arrangement (i.e., the contract) in place with the NB. Traditional precedent under the MDD being maintained under the EU MDR is that, in case of doubt whether a change is significant, the regulatory strategy should be formulated in consultation with the NB.

    

2. Thoroughly explore whether the change in critical component supplier can be justified as not significant.  NBOG precedent (see NBOG 2014-3) and modern reiteration by the MDCG (see MDCG 2020-3) for the EU MDR leave open the possibility that critical supplier and component changes could possibly be justified as being not significant.  I would also add that changes involving devices on the lower end of the risk-class spectrum may have relatively greater liberty to be categorized as not significant.   If the “not significant” argument can be sustained, then it’s profound because such a change and the already-installed devices wouldn’t exceed the “significant change” threshold of EU MDR Article 120(3), consequently allowing continued service under the authority of the MDD DoC and certificate.  A cornerstone of this rationale is threefold:  a) the devices were already put into service; b) “putting into service” seems by fundamental definition to be just a once-in-a-lifetime event for each device unit; and c) the EU MDR DoC and certification requirements only apply to devices placed on the market, made available on the market, or put into service from 26 May 2021 [notwithstanding the provision of Article 120(5) of course].  Indeed, my interpretation is that, as a general rule, devices put into service under the MDD will never become subject to the EU MDR [except for the conditions in the final sentence of Article 120(3), and except for any ultimate cutoff date (I know of none) for allowing such devices to remain in service] unless a significant change is made (effectively resulting in a “new” device and the need for its own respective conformity assessment and once-in-its-lifetime putting into service).

    

3. On the other hand, if the change in critical component supplier and subsequent replacement of components in previously installed units is definitively found to be significant, then by default, that would seem to effectively result in a “new” device, thus nullifying the eligibility for the EU MDR Article 120(2) and (3) transitional provisions. This means that such a change would not be allowed from 26 May 2021 without a corresponding valid EU MDR DoC and NB certificate for the changed version and unit.  But the NB’s interpretation of this needs to be determined, particularly regarding the aforesaid “new” device notion, as different NBs could have varying interpretations of how they would approach this.