Regulatory Open Forum

Hello, Aliva,

The main point of the Clinical Evaluation Report is to generate and analyze clinical data.  Post-Market Surveillance is one part of that process.  The goal is to provide enough information that supports your conclusions of the risk associated with your device in comparison to the benefit of its use.

BSi provides a good guidance here:
https://www.bsigroup.com/meddev/LocalFiles/en-US/Whitepapers/Generating-clinical-evaluation.pdf

Please note that this is based on MEDDEV 2.7.1 rev 3 so once you review this guidance you will need to go to MEDDEV 2.7.1 rev 4 for the basis of your Clinical Evaluation Report.

BSi covers the main changes in rev 4 here:
https://www.bsigroup.com/meddev/LocalFiles/en-CA/Documents/MedDev-brochure.pdf

There are other guidance documents and white papers out there, but it is best to review a few and then dig into MEDDEV 2.7.1 rev 4.

Also please note that the new Medical Device Regulations have additional requirements.  You will want to keep those in mind as your CER will eventually need to meet those requirements.

Best regards,

------------------------------
John Minier, RAC
Consultant, Principal
Minier Medical Device Consulting
john@johnminier.com
1(914)850-4432
Highland Mills, NY
United States
------------------------------

Original Message:
Sent: 13-Sep-2017 06:41
From: Aliva Das
Subject: Clinical Evaluation Report (CER) and Post Market Surveillance Report

Hello everyone,

This question pertains to the elements of  a Technical File. Are both CER and PMS required for the Technical File or having either of them will fulfill the requirements. Since, CER has a section for the Post Market surveillance data is it sufficient or one needs a standalone report for the PMS section. During a Technical File Audit, does notified body look for the completion of both the sections. Please advise on this and any recommendations are welcome.

Thank you,

Regards,

Aliva.

I agree with John who has provided good answers and resources.  In my experience, a CER is the key document that a NB will look during an audit.  It is important to read through the resources that John has provided and prepare the CER meeting the NB's requirements and the new MDR in the near future.

------------------------------
Lin Wu RAC
Waltham MA
United States
------------------------------

Original Message:
Sent: 13-Sep-2017 06:41
From: Aliva Das
Subject: Clinical Evaluation Report (CER) and Post Market Surveillance Report

Hello everyone,

This question pertains to the elements of  a Technical File. Are both CER and PMS required for the Technical File or having either of them will fulfill the requirements. Since, CER has a section for the Post Market surveillance data is it sufficient or one needs a standalone report for the PMS section. During a Technical File Audit, does notified body look for the completion of both the sections. Please advise on this and any recommendations are welcome.

Thank you,

Regards,

Aliva.

I infer that your questions are about the EU Medical Device Directive, MDD, for a product with Annex II as the conformity assessment path.

 

In Annex II, section 3.1 2^nd paragraph, 7^th indent, the manufacturer conducts clinical evaluation following Annex X. Companies follow the guidance document, currently MEDDEV 2.7.1 rev 4. In this guidance, perform the clinical evaluation process for the device and write a clinical evaluation report. The report is a one-time event required before putting the CE Mark on the device. After placing the device on the market, manufacturer conducts post-market surveillance (PMS). The PMS generates new information including safety reports, complaints, published literature, post-market Clinical Follow-up (PMCF) studies, and signals generated by exceeding threshold values.

 

Update the clinical evaluation:

When new PMS information could change the current evaluation

Annually for significant risk or not well-established devices

Otherwise, every 2 to 5 years

 

The MDD Annex II does not have an explicit description of the contents of the technical documentation for Class IIa and Class IIb devices. The NB would check samples of the technical documentation for the information in MDD Annex II, section 3.2(c). This is a long list but includes the pre-clinical evaluation and the clinical evaluation referred to in Annex X.

 

The MDD requires a PMS process, vigilance, etc. However, it does not explicitly require a PMS report. The PMS process leads to the clinical evaluation update on a periodic basis.

 

The NB should check the technical documentation for the clinical evaluation updates based on your documented update schedule.

 

You PMS activities should update the clinical evaluation, include results (including incremental results) from Post-market Clinical Follow-up (PMCF) studies, updates to EN ISO 14971:2012 Clause 9 production and post-production information, vigilance report, Field Safety Corrective Actions (FSCA) & Field Safety Notices (FSN), and EN ISO 13485:2016 corrective actions under 8.5.2.

------------------------------
Dan O'Leary
Swanzey NH
United States
------------------------------

Original Message:
Sent: 13-Sep-2017 06:41
From: Aliva Das
Subject: Clinical Evaluation Report (CER) and Post Market Surveillance Report

Hello everyone,

This question pertains to the elements of  a Technical File. Are both CER and PMS required for the Technical File or having either of them will fulfill the requirements. Since, CER has a section for the Post Market surveillance data is it sufficient or one needs a standalone report for the PMS section. During a Technical File Audit, does notified body look for the completion of both the sections. Please advise on this and any recommendations are welcome.

Thank you,

Regards,

Aliva.

​There can't be a requirement for the CER or PMS to be part of the technical file, because there is no requirement for (nor even any reference to) a technical file in the MDD.  (Nor is there any reference to a technical file in the MDR, as I just learned at the RAPS EU workshop this weekend.)



------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Durham, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

Original Message:
Sent: 13-Sep-2017 06:41
From: Aliva Das
Subject: Clinical Evaluation Report (CER) and Post Market Surveillance Report

Hello everyone,

This question pertains to the elements of  a Technical File. Are both CER and PMS required for the Technical File or having either of them will fulfill the requirements. Since, CER has a section for the Post Market surveillance data is it sufficient or one needs a standalone report for the PMS section. During a Technical File Audit, does notified body look for the completion of both the sections. Please advise on this and any recommendations are welcome.

Thank you,

Regards,

Aliva.

My goal was to respond to Aliva's question about the association between Clinical Data, Post-Market Surveillance, and the Clinical Evaluation Report, not to pick on the wording of the question.

I plan to start a separate discussion of the use of the term Technical File as I think we need some clarification on its use.

Best regards,

------------------------------
John Minier, RAC
Consultant, Principal
Minier Medical Device Consulting
john@johnminier.com
1(914)850-4432
Highland Mills, NY
United States
------------------------------

Original Message:
Sent: 14-Sep-2017 08:59
From: Julie Omohundro
Subject: Clinical Evaluation Report (CER) and Post Market Surveillance Report

​There can't be a requirement for the CER or PMS to be part of the technical file, because there is no requirement for (nor even any reference to) a technical file in the MDD.  (Nor is there any reference to a technical file in the MDR, as I just learned at the RAPS EU workshop this weekend.)



------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Durham, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com

Original Message:
Sent: 13-Sep-2017 06:41
From: Aliva Das
Subject: Clinical Evaluation Report (CER) and Post Market Surveillance Report

Hello everyone,

This question pertains to the elements of  a Technical File. Are both CER and PMS required for the Technical File or having either of them will fulfill the requirements. Since, CER has a section for the Post Market surveillance data is it sufficient or one needs a standalone report for the PMS section. During a Technical File Audit, does notified body look for the completion of both the sections. Please advise on this and any recommendations are welcome.

Thank you,

Regards,

Aliva.

 

​The wording of any question determines how, and even, if it can be answered, as well as the extent to which the answer really addresses what the person wants to know.  This post has three questions:

 

1. Are both CER and PMS required for the Technical File or having either of them will fulfill the requirements?

 

2. Since, CER has a section for the Post Market surveillance data is it sufficient or one needs a standalone report for the PMS section?

 

3. During a Technical File Audit, does notified body look for the completion of both the sections?

 
The second can be answered as is, because it makes no reference to a technical file. 

I was aiming to sort out potential confusion created by the reference to a technical file in the other two questions.  The first question s based on the assumption that there is a technical file and that certain documents must be included in it. The third question again assumes that there is a technical file, and also that it has sections, and also that the NB looks at these sections.

 

 

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Durham, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

Original Message:
Sent: 14-Sep-2017 12:29
From: John Minier
Subject: Clinical Evaluation Report (CER) and Post Market Surveillance Report

My goal was to respond to Aliva's question about the association between Clinical Data, Post-Market Surveillance, and the Clinical Evaluation Report, not to pick on the wording of the question.

I plan to start a separate discussion of the use of the term Technical File as I think we need some clarification on its use.

Best regards,

------------------------------
John Minier, RAC
Consultant, Principal
Minier Medical Device Consulting
john@johnminier.com
1(914)850-4432
Highland Mills, NY
United States

Original Message:
Sent: 14-Sep-2017 08:59
From: Julie Omohundro
Subject: Clinical Evaluation Report (CER) and Post Market Surveillance Report

​There can't be a requirement for the CER or PMS to be part of the technical file, because there is no requirement for (nor even any reference to) a technical file in the MDD.  (Nor is there any reference to a technical file in the MDR, as I just learned at the RAPS EU workshop this weekend.)



------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Durham, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com

Original Message:
Sent: 13-Sep-2017 06:41
From: Aliva Das
Subject: Clinical Evaluation Report (CER) and Post Market Surveillance Report

Hello everyone,

This question pertains to the elements of  a Technical File. Are both CER and PMS required for the Technical File or having either of them will fulfill the requirements. Since, CER has a section for the Post Market surveillance data is it sufficient or one needs a standalone report for the PMS section. During a Technical File Audit, does notified body look for the completion of both the sections. Please advise on this and any recommendations are welcome.

Thank you,

Regards,

Aliva.

I have the following comments:

• Annex II of the EUMDR contains the structure of the technical file of the medical devices to be used in the EU (pages 108-111)
• in section 6. (p. 109) Product verification and validation, 6.1. is about the preclinical and clinical data, which include:
• c) the clinical evaluation report and its updates and the clinical evaluation plan referred to in Article 61(12) and Part A of Annex XIV; (d) the PMCF plan and PMCF evaluation report referred to in Part B of Annex XIV or a justification why a PMCF is not applicable.
• Annex III. (p.112.) is TECHNICAL DOCUMENTATION ON POST-MARKET SURVEILLANCE

Regards

------------------------------
Peter Mikó M.D
ArtPharm Ltd.
Gyermely
Hungary
------------------------------

Original Message:
Sent: 14-Sep-2017 15:00
From: Julie Omohundro
Subject: Clinical Evaluation Report (CER) and Post Market Surveillance Report

 

​The wording of any question determines how, and even, if it can be answered, as well as the extent to which the answer really addresses what the person wants to know.  This post has three questions:

 

1. Are both CER and PMS required for the Technical File or having either of them will fulfill the requirements?

 

2. Since, CER has a section for the Post Market surveillance data is it sufficient or one needs a standalone report for the PMS section?

 

3. During a Technical File Audit, does notified body look for the completion of both the sections?

The second can be answered as is, because it makes no reference to a technical file.

I was aiming to sort out potential confusion created by the reference to a technical file in the other two questions.  The first question s based on the assumption that there is a technical file and that certain documents must be included in it. The third question again assumes that there is a technical file, and also that it has sections, and also that the NB looks at these sections.

 

 

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Durham, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com

Original Message:
Sent: 14-Sep-2017 12:29
From: John Minier
Subject: Clinical Evaluation Report (CER) and Post Market Surveillance Report

My goal was to respond to Aliva's question about the association between Clinical Data, Post-Market Surveillance, and the Clinical Evaluation Report, not to pick on the wording of the question.

I plan to start a separate discussion of the use of the term Technical File as I think we need some clarification on its use.

Best regards,

------------------------------
John Minier, RAC
Consultant, Principal
Minier Medical Device Consulting
john@johnminier.com
1(914)850-4432
Highland Mills, NY
United States

Original Message:
Sent: 14-Sep-2017 08:59
From: Julie Omohundro
Subject: Clinical Evaluation Report (CER) and Post Market Surveillance Report

​There can't be a requirement for the CER or PMS to be part of the technical file, because there is no requirement for (nor even any reference to) a technical file in the MDD.  (Nor is there any reference to a technical file in the MDR, as I just learned at the RAPS EU workshop this weekend.)



------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Durham, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com

Original Message:
Sent: 13-Sep-2017 06:41
From: Aliva Das
Subject: Clinical Evaluation Report (CER) and Post Market Surveillance Report

Hello everyone,

This question pertains to the elements of  a Technical File. Are both CER and PMS required for the Technical File or having either of them will fulfill the requirements. Since, CER has a section for the Post Market surveillance data is it sufficient or one needs a standalone report for the PMS section. During a Technical File Audit, does notified body look for the completion of both the sections. Please advise on this and any recommendations are welcome.

Thank you,

Regards,

Aliva.