New MDCG guidance on legacy devices – Initial thoughts

Giovanni Di Rienzo Giovanni assessed over 400 design dossiers or technical files of high-risk devices in the cardiovascular, endovascular and neurovascular field, including drug-device combinations, absorbable devices and devices containing animal tissue and has overseen the assessment of many more. 

On October 20th the MDCG group published two new guidance documents, one related to article 16 (MDCG 2021-26) and one to legacy devices in the transitional period (MDCG 2021-25).

MDCG 2021-25 is essentially the outcome of a recent meeting of the MDCG task force on transitional provisions under article 120. It is an interesting, although not completely exhaustive, document providing some clarification on how MDD/AIMDD devices should be handled in the transition period.

It starts from the definition (aligned with MDCG 2021-13) of legacy devices, i.e., those devices being currently placed on the market under an MDD/AIMDD certificate, and old devices, i.e., those devices placed on the market under an MDD/AIMDD certificate before the date of application in May 2021.

There are quite some details on the MDR requirements applicable to legacy devices. All the new PMS requirements are applicable to legacy devices too, including the requirement to prepare and update a PSUR. However, the PSUR (apparently irrespective of the classification) does not have to be “pro-actively” submitted to the Notified Body but will be reviewed as part of the regular surveillance audits.

The requirements for economic operators (articles 10-14) are only partially applicable. For example, importers are not simply required to register themselves as we might have thought, this being the only requirement explicitly mentioned in article 120(3). They also have to verify the devices have been registered, and they must comply with anything in article 13 related to PMS. The guidance document is quite detailed in listing articles and subclauses applicable for manufacturers, EU representative, importers, and distributors.

Much to our surprise article 15 is mentioned as not applicable to legacy devices: so, a PRRC is not required. This is definitely unexpected as the PRRC holds responsibilities linked to PMS and therefore it was general understanding, also corroborated by some Notified Bodies, that a Person Responsible for Regulatory Compliance had to be in place from the date of application for both legacy and MDR devices.

Not many details are provided for old devices: the general principle is that they have to comply with the rules applicable when they were placed on the market, so not the MDR requirements. For once a pragmatic approach; however the door is left open to the Market Surveillance working group within the MDCG to define the “practical aspects”. So there might be further surprises.

All in all, it is a useful document, although probably published at least 1 year too late. It has some surprises, but it is helpful in clarifying the path and creating a (more) level playing field. Now hopefully we will see something similar being published also for the IVDR.


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