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Is the MDCG guidance on ‘significant changes’ misinterpreting the MDR?

  • Posted by: inetika
  • Category: GLOBAL NEWS

The Commission has recently published document reference MDCG 2020-3, ‘MDCG guidance on significant changes in the context of MDR Article 120’, but has it made a fundamental error in its understanding of the MDR wording, or is it a deliberate (mis)interpretation?

MDR Article 120(3) states: “. . . provided there are no significant changes in the design and intended purpose”, implying that changes to both design and intended purpose must occur before “the requirements of this Regulation relating to post-market surveillance, market surveillance, vigilance, registration of economic operators and of devices” apply to ‘legacy devices’.

The guidance, in its third paragraph, states: “. . . require that no significant changes in design or intended purpose of a device be performed after the date of application of the MDR”.

This is compounded throughout the guidance, including in the flowcharts. For example, in the Main Chart, the first question relates to a change in the intended purpose. If ‘yes’, it sends the reader to Chart A. The result of assessing the intended purpose change by means of Chart A is either ‘Return to Main Chart at point X‘ or ‘Change is significant‘. If the change is considered ‘significant’ in Chart A, there is no link back to the Main Chart to allow determination of whether the change is also a significant design change. The important difference between ‘and’ and ‘or’ appears therefore to have been ignored.

To properly reflect the MDR wording, there probably should be two separate flowcharts, one for intended purpose and the other for design. Only if both resulted in ‘significant’ conclusions would the additional MDR requirements for the legacy devices concerned be applicable, if a strict interpretation of the MDR wording is taken.

If this misstatement of Art 120(3) is deliberate on the part of the drafting group, because it is believed this is how the article should be applied, then the proper way to do this would have been to include the replacement of ‘and’ by ‘or’ in the second corrigendum, which made significant changes to Article 120(3). This did not happen, so can it be assumed that the Commission is happy with the word ‘and’ in this context? If this is the case, then should the new guidance be allowed to stand?

From industry’s perspective, this appears to be something of an ‘own goal’, because the MDCG guidance is heavily based on a draft provided by a joint industry group over one year ago, and this also made the same ‘interpretation’ of ‘and’ by changing it to ‘or’ in several places, and to ‘and/or’ in another. Has industry been deliberately complicit in this mis(interpretation? And where do we go from here?