Class IIa medical products - PMS report and PSUR

[GalitSa]

Regarding MDR 2017/745 requirements , are both required or just PSUR?

 

[shimonv]

You need PMS plan and PSUR report.
PMS report is intended for class I deivce.

 

[Philip B]

We sell both Class I (sterile) and IIa devices so I'm going to do a PSUR for both on the assumption that the higher requirement of the PSUR will more than cover our Class Is. Our NB may or may not have a problem with this, you can never tell...

 

[Weeder]

You need PMS plan and PSUR report.
PMS report is intended for class I deivce.

Do we need a PSUR under MDD. I have prepared the PMS plan but I am not sure if I should prepare the PSUR while still under MDD. Will the Technical Documentation reviewer object to having a PSUR under MDD (since it is not a requirement) or will it be looked as a plus that I am thinking ahead?

 

[shimonv]

You don't need PSUR under MDD; it's only required for MDR.
I think that in the current state of things it's better to stick to MDD processes. Not all technical reviews are certified for MDR, and they cannot give you feedback or findings unrelated to MDD.

Shimon

 

[primavesvera]

Do we need a PSUR under MDD. I have prepared the PMS plan but I am not sure if I should prepare the PSUR while still under MDD. Will the Technical Documentation reviewer object to having a PSUR under MDD (since it is not a requirement) or will it be looked as a plus that I am thinking ahead?

We had the audit in January for CE certification and our auditor wrote us a recommendation to implement PMS requirements from MDR based on the art. 120(3): By way of derogation from Article 5 of this Regulation, a device with a certificate that was issued in accordance with Directive 90/385/EEC or Directive 93/42/EEC and which is valid by virtue of paragraph 2 of this Article may only be placed on the market or put into service provided that from the date of application of this Regulation it continues to comply with either of those Directives, and provided there are no significant changes in the design and intended purpose. 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.

 

[Weeder]

We had the audit in January for CE certification and our auditor wrote us a recommendation to implement PMS requirements from MDR based on the art. 120(3): By way of derogation from Article 5 of this Regulation, a device with a certificate that was issued in accordance with Directive 90/385/EEC or Directive 93/42/EEC and which is valid by virtue of paragraph 2 of this Article may only be placed on the market or put into service provided that from the date of application of this Regulation it continues to comply with either of those Directives, and provided there are no significant changes in the design and intended purpose. 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.

I think Shimonv is right that it best to stick with the current MDD specially for surveillance audits and TF reviews. It would be outside the scope of the MDD audit specially now that the dead line is a year away.