Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Greetings,

I'm new to the regulatory space regarding the clinical evaluation and post-market surveillance requirements under MDR. I need some guidance regarding PMS, CERs, PMCF, and PSUR.

My company manufactures Class IIa devices and I understand that according to Article 84 we require a PMS Plan and PSUR according to Article 86. My questions are as follows:

Is the post-market surveillance plan overarching, meaning it covers all PMS activities, including compiling the CER and what the contents of the CER should include, point to the PMCF plan, also point to PSUR?

Or, are we also required to have a separate Clinical Evaluation Plan to produce the report? 

We're starting to confuse ourselves regarding what documents we are required to generate. There appears to be a tremendous amount of overlap and if I can avoid confusing my team that would be great.

Any assistance and an easy explanation of how things are connected and what we require would be most helpful!

I believe there are a few RAPS articles available, including this one.  Also, the IMDRF and WHO have some more general PMS documentation that may be helpful in general.  Worse comes to worst, RAPS will happily take your money too.

------------------------------
Christopher Erwin
Scottsdale AZ
United States
------------------------------

Original Message:
Sent: 14-Feb-2022 15:49
From: Anonymous Member
Subject: PMS, CER, PMCF, PSUR - CONFUSION!

This message was posted by a user wishing to remain anonymous

Greetings,

I'm new to the regulatory space regarding the clinical evaluation and post-market surveillance requirements under MDR. I need some guidance regarding PMS, CERs, PMCF, and PSUR.

My company manufactures Class IIa devices and I understand that according to Article 84 we require a PMS Plan and PSUR according to Article 86. My questions are as follows:

Is the post-market surveillance plan overarching, meaning it covers all PMS activities, including compiling the CER and what the contents of the CER should include, point to the PMCF plan, also point to PSUR?

Or, are we also required to have a separate Clinical Evaluation Plan to produce the report?

We're starting to confuse ourselves regarding what documents we are required to generate. There appears to be a tremendous amount of overlap and if I can avoid confusing my team that would be great.

Any assistance and an easy explanation of how things are connected and what we require would be most helpful!

Hi,

Each product need to have a CEP and a CER (there are good MDCG 2020-1 to be followed to write CER).
In the CER, your benefit risk evaluation will also defined your need of a PMCF linked to your clinical data and your risk management.
The PMS plan describes all you sources for Post Market Surveillance.(including customer feedback, complaints, CAPA, FSCA, etc...) 
On a regular basis depending the risk classification of your product, you have to update your CER with PMS data. For class IIa, it is at least every two years if don't have any safety issues before.
Those data will be used as well to write your PSUR that have to be introduced in EUDAMED. (also at least every 2 years for class IIa device)

In Summary you need all the following documents : CEP, CER,  PMS plan and a PMS report, PMCF plan and report or justification for not having this and at least every 2 years a PSUR that includes all the requirements described into Article 86 and an update of your CER with those data and litterature review update.

Hope this clarifies your point

------------------------------
Anne-Sophie Grell
RA Manager
Antwerpen
Belgium
------------------------------

Original Message:
Sent: 14-Feb-2022 15:49
From: Anonymous Member
Subject: PMS, CER, PMCF, PSUR - CONFUSION!

This message was posted by a user wishing to remain anonymous

Greetings,

I'm new to the regulatory space regarding the clinical evaluation and post-market surveillance requirements under MDR. I need some guidance regarding PMS, CERs, PMCF, and PSUR.

My company manufactures Class IIa devices and I understand that according to Article 84 we require a PMS Plan and PSUR according to Article 86. My questions are as follows:

Is the post-market surveillance plan overarching, meaning it covers all PMS activities, including compiling the CER and what the contents of the CER should include, point to the PMCF plan, also point to PSUR?

Or, are we also required to have a separate Clinical Evaluation Plan to produce the report?

We're starting to confuse ourselves regarding what documents we are required to generate. There appears to be a tremendous amount of overlap and if I can avoid confusing my team that would be great.

Any assistance and an easy explanation of how things are connected and what we require would be most helpful!

Hello Anon,

As re-iterated by the others, yes all of those documentation are needed as part of the Technical Documentation Annex II and Annex III.  Based on your questions, it might be advantageous to take a EU MDR training course which covers the topics you are inquiring about which can provide more detail and some real-time applications.

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

Original Message:
Sent: 15-Feb-2022 02:57
From: Anne-Sophie Grell
Subject: PMS, CER, PMCF, PSUR - CONFUSION!

Hi,

Each product need to have a CEP and a CER (there are good MDCG 2020-1 to be followed to write CER).
In the CER, your benefit risk evaluation will also defined your need of a PMCF linked to your clinical data and your risk management.
The PMS plan describes all you sources for Post Market Surveillance.(including customer feedback, complaints, CAPA, FSCA, etc...)
On a regular basis depending the risk classification of your product, you have to update your CER with PMS data. For class IIa, it is at least every two years if don't have any safety issues before.
Those data will be used as well to write your PSUR that have to be introduced in EUDAMED. (also at least every 2 years for class IIa device)

In Summary you need all the following documents : CEP, CER,  PMS plan and a PMS report, PMCF plan and report or justification for not having this and at least every 2 years a PSUR that includes all the requirements described into Article 86 and an update of your CER with those data and litterature review update.

Hope this clarifies your point

------------------------------
Anne-Sophie Grell
RA Manager
Antwerpen
Belgium

Original Message:
Sent: 14-Feb-2022 15:49
From: Anonymous Member
Subject: PMS, CER, PMCF, PSUR - CONFUSION!

This message was posted by a user wishing to remain anonymous

Greetings,

I'm new to the regulatory space regarding the clinical evaluation and post-market surveillance requirements under MDR. I need some guidance regarding PMS, CERs, PMCF, and PSUR.

My company manufactures Class IIa devices and I understand that according to Article 84 we require a PMS Plan and PSUR according to Article 86. My questions are as follows:

Is the post-market surveillance plan overarching, meaning it covers all PMS activities, including compiling the CER and what the contents of the CER should include, point to the PMCF plan, also point to PSUR?

Or, are we also required to have a separate Clinical Evaluation Plan to produce the report?

We're starting to confuse ourselves regarding what documents we are required to generate. There appears to be a tremendous amount of overlap and if I can avoid confusing my team that would be great.

Any assistance and an easy explanation of how things are connected and what we require would be most helpful!

When I entered the Drug Reg environment a few years back, I started collecting acronyms.  I'm up to about 1,200.  I'll add Clinical Effectiveness Plan to the list of ones I already have for CER, though it seems like it should be CEP.

CER	Certificate of Registration (devices); Comparative Effectiveness Research; OR Clincial Evaluation Report, depending on context

------------------------------
[Stephen] [Hellebusch] [Ph.D.]
[Consultant]
[HellRC]
[Dallas, Chicago] []
[USA]
------------------------------

Original Message:
Sent: 14-Feb-2022 15:49
From: Anonymous Member
Subject: PMS, CER, PMCF, PSUR - CONFUSION!

This message was posted by a user wishing to remain anonymous

Greetings,

I'm new to the regulatory space regarding the clinical evaluation and post-market surveillance requirements under MDR. I need some guidance regarding PMS, CERs, PMCF, and PSUR.

My company manufactures Class IIa devices and I understand that according to Article 84 we require a PMS Plan and PSUR according to Article 86. My questions are as follows:

Is the post-market surveillance plan overarching, meaning it covers all PMS activities, including compiling the CER and what the contents of the CER should include, point to the PMCF plan, also point to PSUR?

Or, are we also required to have a separate Clinical Evaluation Plan to produce the report?

We're starting to confuse ourselves regarding what documents we are required to generate. There appears to be a tremendous amount of overlap and if I can avoid confusing my team that would be great.

Any assistance and an easy explanation of how things are connected and what we require would be most helpful!

Love that you have 1200 acronyms.   Do you sell your list or want to share it?    Could use it in training....   or Bingo!

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

Original Message:
Sent: 15-Feb-2022 09:09
From: Stephen Hellebusch
Subject: PMS, CER, PMCF, PSUR - CONFUSION!

When I entered the Drug Reg environment a few years back, I started collecting acronyms.  I'm up to about 1,200.  I'll add Clinical Effectiveness Plan to the list of ones I already have for CER, though it seems like it should be CEP.

CER	Certificate of Registration (devices); Comparative Effectiveness Research; OR Clincial Evaluation Report, depending on context

------------------------------
[Stephen] [Hellebusch] [Ph.D.]
[Consultant]
[HellRC]
[Dallas, Chicago] []
[USA]

Original Message:
Sent: 14-Feb-2022 15:49
From: Anonymous Member
Subject: PMS, CER, PMCF, PSUR - CONFUSION!

This message was posted by a user wishing to remain anonymous

Greetings,

I'm new to the regulatory space regarding the clinical evaluation and post-market surveillance requirements under MDR. I need some guidance regarding PMS, CERs, PMCF, and PSUR.

My company manufactures Class IIa devices and I understand that according to Article 84 we require a PMS Plan and PSUR according to Article 86. My questions are as follows:

Is the post-market surveillance plan overarching, meaning it covers all PMS activities, including compiling the CER and what the contents of the CER should include, point to the PMCF plan, also point to PSUR?

Or, are we also required to have a separate Clinical Evaluation Plan to produce the report?

We're starting to confuse ourselves regarding what documents we are required to generate. There appears to be a tremendous amount of overlap and if I can avoid confusing my team that would be great.

Any assistance and an easy explanation of how things are connected and what we require would be most helpful!

To get a clear understanding of all this you need a framework. In the EU-MDR there are many systems such as the PMS system and the Clinical Evaluation system. Systems has elements: purpose, QMS procedure, plan, initial report, and updated report. However, not all systems have all elements.

The systems are interrelated in that each system provides information to other systems. The Notified Body, NB, under Annex VII, must verify that your procedures include this exchange of information. In other words, the systems cannot be in separate silos.

My recommendation is that you draw a directed graph showing how information moves. The nodes are the system elements (including the Article and Annex) and the directed edges are the information flow. Label each edge with the information. I started with a stack of 11x17 paper, a good pencil, and a non-smudging eraser. It will take time and effort, but you will learn a lot.

The EU-MDR is not well written in that articles refer to other articles, annexes, etc. You need to figure out the connections as they apply to your product. Think of it as straitening a bowl of cooked Raman noodles. Also, notice that there can be plans inside plans and reports inside reports. For example, the Clinical Evaluation Plan has a Clinical Development Plan inside it.

Divide the EU-MDR into phases, pre-market and post-market. Some activities are completed before putting the MDR CE Mark on the product (pre-market) and some after (post-market). Legacy devices blur this distinction for some systems.

The systems you need to understand are the GS&PR system, the Clinical Evaluation system, the Risk Management system, the PMS system, the PMCF system, and the SSCP system.

For the Clinical Evaluation system, don't call it the CER because that creates confusion. It requires a Clinical Evaluation Plan and a Clinical Evaluation Report, both of which are pre-market. It also has a Clinical Evaluation Assessment Report, that the NB writes as a pre-market activity.

The Risk Management system doesn't have a report in the same sense as the other system. Its report serves a different purpose. Both the plan and report are pre-market.

For the GS&PR system, I think of the plan as the identification of the requirements that apply and the rationale for those that don't. The report is the identification of how you demonstrate conformity such as standards or EU legislation. Both plan and report are pre-market.

The SSCP system doesn't have a plan. The report is the SSCP (in all the appropriate languages) on the EudaMed website. You may not need an SSCP for a Class IIa device.

------------------------------
Dan O'Leary CQA, CQE
Swanzey NH
United States
------------------------------

Original Message:
Sent: 14-Feb-2022 15:49
From: Anonymous Member
Subject: PMS, CER, PMCF, PSUR - CONFUSION!

This message was posted by a user wishing to remain anonymous

Greetings,

I'm new to the regulatory space regarding the clinical evaluation and post-market surveillance requirements under MDR. I need some guidance regarding PMS, CERs, PMCF, and PSUR.

My company manufactures Class IIa devices and I understand that according to Article 84 we require a PMS Plan and PSUR according to Article 86. My questions are as follows:

Is the post-market surveillance plan overarching, meaning it covers all PMS activities, including compiling the CER and what the contents of the CER should include, point to the PMCF plan, also point to PSUR?

Or, are we also required to have a separate Clinical Evaluation Plan to produce the report?

We're starting to confuse ourselves regarding what documents we are required to generate. There appears to be a tremendous amount of overlap and if I can avoid confusing my team that would be great.

Any assistance and an easy explanation of how things are connected and what we require would be most helpful!

Feel free to reach out to info@complianceacuity.com for a free copy of my illustration called "Interconnection of Clinical Evaluation, PMS and PMCF from a Certification / Market-Entry Perspective per EU Regulation 2017/745".  You may find the illustration useful as you piece together the various interrelationships.  This is inside my whitepaper entitled, "Navigating PMCF and its Mysterious Relationship to PMS and Clinical Evaluation in EU Regulation 2017/745."

------------------------------
Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2022 by ComplianceAcuity, Inc. All rights reserved.
------------------------------

Original Message:
Sent: 14-Feb-2022 15:49
From: Anonymous Member
Subject: PMS, CER, PMCF, PSUR - CONFUSION!

This message was posted by a user wishing to remain anonymous

Greetings,

I'm new to the regulatory space regarding the clinical evaluation and post-market surveillance requirements under MDR. I need some guidance regarding PMS, CERs, PMCF, and PSUR.

My company manufactures Class IIa devices and I understand that according to Article 84 we require a PMS Plan and PSUR according to Article 86. My questions are as follows:

Is the post-market surveillance plan overarching, meaning it covers all PMS activities, including compiling the CER and what the contents of the CER should include, point to the PMCF plan, also point to PSUR?

Or, are we also required to have a separate Clinical Evaluation Plan to produce the report?

We're starting to confuse ourselves regarding what documents we are required to generate. There appears to be a tremendous amount of overlap and if I can avoid confusing my team that would be great.

Any assistance and an easy explanation of how things are connected and what we require would be most helpful!