Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Dear all,

We have a class I device under MDD - in MDD no obligation to have a dedicated PMS report for class I. The device is classified as IIa under MDR. PMS plan prepared according to MDR; MDR certificate not issued yet. According to MDCG 2022-21, PSUR is not required at the initial MDR certification but two years from the device certification date. Article 86 MDR says, " Manufacturers of class IIa devices shall update the PSUR when necessary and at least every two years."

The PMS plan is dated 2021 and then revised in 2022. Is it so that we should have the first PSUR available in 2024 (a current, updated version of our PMS plan is in 2022) as per article 86 MDR, or if we get an MDR certificate in the year 2023, then we should have the first PSUR available o 2025, as per MDCG-2022-21?

Thank you for clarification!

Hi, 

If your product was already on the market under MDD you are supposed to provide a PSUR with your MDR submission as you have already post market surveillance data, or at least supposed to.  and from them you can apply the rule "at once every 2 years". 

Hope it clarifies. 

Bets regards, 

------------------------------
Anne-Sophie Grell
RA Manager
Charleroi
Belgium
------------------------------

Original Message:
Sent: 23-Aug-2023 01:36
From: Anonymous Member
Subject: PSUR/PMS report confusion

This message was posted by a user wishing to remain anonymous

Dear all,

We have a class I device under MDD - in MDD no obligation to have a dedicated PMS report for class I. The device is classified as IIa under MDR. PMS plan prepared according to MDR; MDR certificate not issued yet. According to MDCG 2022-21, PSUR is not required at the initial MDR certification but two years from the device certification date. Article 86 MDR says, " Manufacturers of class IIa devices shall update the PSUR when necessary and at least every two years."

The PMS plan is dated 2021 and then revised in 2022. Is it so that we should have the first PSUR available in 2024 (a current, updated version of our PMS plan is in 2022) as per article 86 MDR, or if we get an MDR certificate in the year 2023, then we should have the first PSUR available o 2025, as per MDCG-2022-21?

Thank you for clarification!

Hello Anon,

The EU MDR regardless of status of EU MDD or EU MDR certification required certain quality system elements to be implemented by May 2021.  This includes Post Market Surveillance (PMS).  Even if your product stayed Class I under the EU MDR, a post market surveillance process would have needed to be implemented by May 2021.  If the product is being up-classified under EU MDR to Class IIa, then even more important to have implemented the process.

There is different interpretations of "when" a PMS Plan (and overall PMS surveillance process) should have been started, but minimally this would have been May 2021.  Which means even a Class IIa under the EU MDR (again regardless of certification status) would need to have a Periodic Safety Update Report (PSUR) already published through a first cycle.  If the product was still a Class I under EU MDR, even with no Notified Body intervention, it still would have been recommended to have issued a Post Market Surveillance Report by now.

The comment about the MDCG 2022-21 guidance not requiring a PSUR at time of certification, but after certification, please take with a "huge bucket of salt" - not a grain (sorry English phrase).  The reason being, most Notified Bodies are expecting the PMS processes to have been implemented in May 2021, so in order to show compliance a PSUR is expected to be shown ... now.  This is the disconnect between the EU Commission, MCDG, "guidance" documents, and what actually happens in reality.  The recommendation is to have a PSUR available as soon as possible - and if you have not already had your EU MDR quality system certification process, this again is usually expected.  If the quality system part has already gone through and they are ok with the PMS Plan, you should really think about having a PSUR at the next surveillance audit, so circa 2024.

------------------------------
Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
------------------------------

Original Message:
Sent: 24-Aug-2023 02:26
From: Anne-Sophie Grell
Subject: PSUR/PMS report confusion

Hi, 

If your product was already on the market under MDD you are supposed to provide a PSUR with your MDR submission as you have already post market surveillance data, or at least supposed to.  and from them you can apply the rule "at once every 2 years". 

Hope it clarifies. 

Bets regards, 

------------------------------
Anne-Sophie Grell
RA Manager
Charleroi
Belgium

Original Message:
Sent: 23-Aug-2023 01:36
From: Anonymous Member
Subject: PSUR/PMS report confusion

This message was posted by a user wishing to remain anonymous

Dear all,

We have a class I device under MDD - in MDD no obligation to have a dedicated PMS report for class I. The device is classified as IIa under MDR. PMS plan prepared according to MDR; MDR certificate not issued yet. According to MDCG 2022-21, PSUR is not required at the initial MDR certification but two years from the device certification date. Article 86 MDR says, " Manufacturers of class IIa devices shall update the PSUR when necessary and at least every two years."

The PMS plan is dated 2021 and then revised in 2022. Is it so that we should have the first PSUR available in 2024 (a current, updated version of our PMS plan is in 2022) as per article 86 MDR, or if we get an MDR certificate in the year 2023, then we should have the first PSUR available o 2025, as per MDCG-2022-21?

Thank you for clarification!

That is exactly correct.  Do not let the Notified Body bully you into having to have a PSUR earlier than 2 years after date of certification.  A client of mine had this happen (certified in Dec 2022), but  we referred them back to the MDR and MDCG and the reply was a "oh, ok we will look at the PMS only during the audit. That said, the MDCG also discusses how it could take a few weeks to prepare the report, but...

Have a reasonable PMS Plan in plan and have the evidence to show you are following it. You should not be waiting until 1 year 9 months to gather PMS data, you can start now. They will look.

Good luck!

------------------------------
Ginger Cantor, MBA, RAC
Founder/Principal Consultant
Centaur Consulting LLC
River Falls, Wisconsin 54022 USA
715-307-1850
centaurconsultingllc@gmail.com
------------------------------

Original Message:
Sent: 23-Aug-2023 01:36
From: Anonymous Member
Subject: PSUR/PMS report confusion

This message was posted by a user wishing to remain anonymous

Dear all,

We have a class I device under MDD - in MDD no obligation to have a dedicated PMS report for class I. The device is classified as IIa under MDR. PMS plan prepared according to MDR; MDR certificate not issued yet. According to MDCG 2022-21, PSUR is not required at the initial MDR certification but two years from the device certification date. Article 86 MDR says, " Manufacturers of class IIa devices shall update the PSUR when necessary and at least every two years."

The PMS plan is dated 2021 and then revised in 2022. Is it so that we should have the first PSUR available in 2024 (a current, updated version of our PMS plan is in 2022) as per article 86 MDR, or if we get an MDR certificate in the year 2023, then we should have the first PSUR available o 2025, as per MDCG-2022-21?

Thank you for clarification!

Hello Anon,

just looking at the PSUR requirements and taking into accounte MDCG 2022-21, the data collection period for your class IIa MDR device would start with the date of certification and for the first PSUR end two years later. As you need some time to summarize the data and prepare and issue your PSUR you can add a reasonable amount of time until the actual report has to be released (I think earlier drafts of the MDCG guidance had a 90 day period for preparation). So if you get your certificate in 2023, then the formal issue date would be in 2025. Because you currently have a class I MDD legacy device, the PSUR requirement is not applicable.

However, the PSUR and its preparation are not identical to your PMS activities (even though you get this impression from the discussions and also from the MDCG guidance). The PSUR merely is a mandatory summary of the results from these activities. The MDR requirements for PMS are applicable also to legacy devices since May 2021, so you are expected to have a respective PMS plan and activities already for your class I MDD legacy device at the latest since then. If you have no significant changes to your device during its transition from MDD class I legacy device to MDR class IIa device, then these PMS data and evaluations should be available and in the best case part of your technical documentation. And independent from the question if there is a formal PSUR, the NB will (correctly) expect to see evidence for the respective activities (and providing a PMS report or PSUR based on your legacy device PMS data might be an easy way to provide that evidence).

So my main point would be: Concentrate on planning, implementing and executing PMS activities that are suitable for your device and provide you the information you need to fulfill your responsibilities as a legal manufacturer. And if you can use the PMS report and/or PSUR as a part of this effort to summarize your findings (not only for the NB or the authorities but also for yourself), then plan this as suits your needs (with a maximum of two years for class IIa). If you can do your PMS activities and evaluations without these formal summaries or have other procedures for that, then plan the PSUR as an additional document at the mandatory dates.

Best regards

Christoph

------------------------------
Christoph Kiesselbach
Reutlingen
Germany
------------------------------

Original Message:
Sent: 23-Aug-2023 01:36
From: Anonymous Member
Subject: PSUR/PMS report confusion

This message was posted by a user wishing to remain anonymous

Dear all,

We have a class I device under MDD - in MDD no obligation to have a dedicated PMS report for class I. The device is classified as IIa under MDR. PMS plan prepared according to MDR; MDR certificate not issued yet. According to MDCG 2022-21, PSUR is not required at the initial MDR certification but two years from the device certification date. Article 86 MDR says, " Manufacturers of class IIa devices shall update the PSUR when necessary and at least every two years."

The PMS plan is dated 2021 and then revised in 2022. Is it so that we should have the first PSUR available in 2024 (a current, updated version of our PMS plan is in 2022) as per article 86 MDR, or if we get an MDR certificate in the year 2023, then we should have the first PSUR available o 2025, as per MDCG-2022-21?

Thank you for clarification!