Significant change in the intended purpose or design of a medical device
Legal background
According to Art. 120 para. 3c lit. b MDR, legacy devices may only continue to be placed on the market as long as they have not undergone a "substantial change" in their intended purpose and design. Despite the wording of Art. 120 para. 3c lit. b MDR, which indicates that there must be a change in the intended purpose and design, it will be sufficient according to the meaning and purpose of the provision if either the intended purpose or the design is significantly changed.
The MDR does not specify when a change is material or immaterial or what is meant by a "change". Rather, these are undefined legal terms that must be interpreted.
Interpretation notes of the Medical Device Coordination Group (MDCG)
The guidance notes of the MDCG can serve as orientation. However, these are merely the legal opinions of an unofficial body and are not binding for authorities or courts. MDCG 2022-6 (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) states that a change of intended purpose is generally significant if the intended purpose is extended. An example of this is the extension of the intended purpose to include a further indication or a further patient group. If, on the other hand, the intended purpose is restricted, the change is generally immaterial.
With regard to the change in design, the MDCG states that design changes made as part of a manufacturer's corrective safety measures are not significant changes. This follows from the fact that a market surveillance and vigilance system must also be set up for legacy products in accordance with the MDR (Art. 120 para. 3d MDR new version). Corrective measures carried out accordingly cannot change the marketability, as the purpose of the transitional provisions for legacy devices is to maintain the marketability of these products for a transitional period.
Change in the risk class
Accordingly, a change in the risk class "downwards" is not a significant change in the intended purpose if and to the extent that this is accompanied by a restriction of the intended purpose.
At the same time, not every change in the risk class "upwards" must represent a significant change in the intended purpose: For example, it is (convincingly) argued in the legal literature that a higher classification of such products that were, for example, assigned to class I under the MDD and now fall into class IIa under the MDR does not constitute a substantial change, as no change was made to the product, but the higher classification occurred by operation of law.
No significant changes
All changes that affect neither the intended purpose nor the design, such as certain changes in quality management or purely aesthetic changes to the products (e.g. the color of the product or its dimensions), are also not significant changes.
In summary, it can be stated that manufacturers must always check in each individual case whether the change affects the intended purpose or the design before changing their legacy devices and, if this is the case, must further check whether the change is material.
Status: 04.05.2023