Just wondering if anyone has encountered the same thing as us in a Notified Body surveillance audit for their MDD legacy device...
EU MDR Article 120(3): "However, the requirements of this Regulation relating to post-market surveillance, market surveillance, vigilance, registration of economic operators and of devices shall apply in place of the corresponding requirements in those Directives."
Therefore, our Notified Body stated that the record retention time in Article 10(8) applies to PMS and Vigilance documents/records per Article 120(3) and MDCG 2022-4, which means we are required to keep those records for our legacy devices longer than what's required by the MDD.
We are struggling with this a bit... Based on MDCG 2022-4, "MDR requirements that are not related to post-market surveillance, market surveillance, vigilance, registration of economic operators and devices should in principle not apply to economic operators in respect to ‘legacy devices’." However, sometimes "related" or "not related" is not that clear. Is our Notified Body's interpretation of "related requirement" reasonable? I'd think that if this is considered applicable, MDCG 2021-25 would have included Article 10(8) in terms of PMS documentation as an example of applicable requirements, but it did not. MDCG 2021-25 states: "In addition, the obligations of economic operators set out in the following provisions should also apply to economic operators with respect to ‘legacy devices :
for manufacturers: Article 10 (10), (12)-(15);
for authorised representatives5 : Article 11(3)(c)-(g)
I am very curious to know if anyone has any experience on this in their NB audit and/or can share some thoughts on this. Thank you!
EU MDR Article 120(3): "However, the requirements of this Regulation relating to post-market surveillance, market surveillance, vigilance, registration of economic operators and of devices shall apply in place of the corresponding requirements in those Directives."
Therefore, our Notified Body stated that the record retention time in Article 10(8) applies to PMS and Vigilance documents/records per Article 120(3) and MDCG 2022-4, which means we are required to keep those records for our legacy devices longer than what's required by the MDD.
We are struggling with this a bit... Based on MDCG 2022-4, "MDR requirements that are not related to post-market surveillance, market surveillance, vigilance, registration of economic operators and devices should in principle not apply to economic operators in respect to ‘legacy devices’." However, sometimes "related" or "not related" is not that clear. Is our Notified Body's interpretation of "related requirement" reasonable? I'd think that if this is considered applicable, MDCG 2021-25 would have included Article 10(8) in terms of PMS documentation as an example of applicable requirements, but it did not. MDCG 2021-25 states: "In addition, the obligations of economic operators set out in the following provisions should also apply to economic operators with respect to ‘legacy devices :
for manufacturers: Article 10 (10), (12)-(15);
for authorised representatives5 : Article 11(3)(c)-(g)
I am very curious to know if anyone has any experience on this in their NB audit and/or can share some thoughts on this. Thank you!
Hope this can help out some colleagues if in the future your NB auditor also raises the same issue.