The Medical Device Coordination Group (MDCG) today published guidance (the Guidance)[1] explaining what constitutes a “significant change” under Article 120 of the Medical Device Regulations (MDR)[2], for devices currently covered by certificates under the Medical Device Directive (MDD)[3] or the Active Implantable Medical Device Directive (AIMDD)[4].

The MDR is coming into force to repeal and replace the outgoing MDD and AIMDD on 26 May 2020, and with it come more stringent regulations. Products that were certified under the MDD or the AIMDD need to be re-certified under the MDR before they can be placed on the market. This could cause a huge drop in access to crucial medical devices due to the industry Notified Bodies having a backlog of devices to certify under the MDR, which would badly affect patients reliant on such devices.

To avoid such a catastrophe, Articles 120(2) and 120(3) MDR stat|e that devices which have a valid certificate under the MDD and AIMDD may continue to be placed on the market or put into service after 26 May 2020 under certain conditions, until 26 May 2024.

The conditions referred to, require that “no significant change in design or intended purpose” are made to the device, after the application of the MDR on 26 May 2020. A big question for the industry, has been what is meant by “significant changes”.

First, the Guidance makes clear that no new certificates can be issued under the MDD or the AIMDD. Any changes made to the product or the manufacturing process must be notified to the relevant Notified Body as part of the surveillance activities under the MDR. The outcome under this assessment will determine whether a significant change has occurred.

The Guidance sets out that administrative changes of organisations are, in principle, not to be considered significant changes. This extends to all changes not having an impact on the design or the intended purpose. These include the addition of new manufacturing sites or particular changes to the quality management system. It is important to note that any change, including the examples above of non-significant changes, must still be reported to a Notified Body under the surveillance regime.

The Guidance states, rather unhelpfully, that “when the change is likely to affect the design or the intended purpose of the device”, this could constitute a significant change.

The Guidance does states that the Notified Body that issued the AIMDD or MDD certificate for a device, may, after reviewing the manufacturer’s description of proposed changes, confirm in writing that any such implementation does not represent a significant change in design or intended purpose on Article 120(3), as well as confirming that any MDD or AIMDD certificate remains valid. This confirmation does not constitute a supplemented certificate.

Although the preamble contained in the Guidance does little to alleviate the ambiguity, the Guidance does include a very helpful flowchart based on previous NBOG guidance.

This flowchart lists 6 key questions set out below:

1. Is there a change to the intended purpose?
2. Is the design change related to corrective actions? (If so this is always a significant change).
3. Is there a change of the design or performance specification?
4. Is there a software change?
5. Is there a change to the material?
6. Is there a change of terminal sterilisation method of the device or packaging design with impact to the sterilisation?

If a manufacturer answers yes to any of the above questions, they are taken to a separate flow chart that has some specific and relevant questions, allowing manufacturers to ascertain whether a change is “significant”.

The flow charts contained in the Guidance provide some useful advice for manufacturers going forward, although more definitive advice won’t be available until the Notified Bodies begin considering specific cases.

[1] 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

[2] 2017/745

[3] 93/42/EEC

[4] 90/385/EEC