Clinical Evidence and Expert Evaluation - Guidance Notes (MEDDEV 2.7.1)

Ronen E

Problem Solver
Moderator
NO, you have to complete the clinical evaluation of your own device.

I would say that if the full clinical evidence report for a similar device is available, it can be very helpful.

Mathenga: You need to show that the devices are equivalent, if you intend to rely on that. You can't submit the other device's report as is but you can utilise parts of it in yours.

Cheers,
Ronen.
 

medwise

Involved In Discussions
Mathenga recently I've written a couple of clinical evaluation reports which has been successfully accepted by our regulatory body and could advise you the following approaches -
1. Document your literature search taking into account -

? documented literature search strategy including information such as databases searched, search terms used, any inclusion and exclusion criteria
? critical appraisal of the literatures with particular emphasis on how the publications demonstrates safety and performance
2. Justifications for comparator/predicate devices ?

? If there are no actual clinical data for the specific device, depending upon the nature of it and the reasons for submission, it may be possible to provide a full clinical justification for why new clinical data is not required.

? Typically, a justification may reference the clinical safety and performance data of a ?predicate? or similar marketed device and critically examine each change or difference in terms of materials, design, clinical use, and their likely impact on safety and performance.

? A justification may also take the form of a minor change to a currently approved device, where the change is considered too minor to have any clinical impact, and this is justified by the clinical expert.

? If it can be established via justification that changes do not pose any clinical impact on safety and performance, a clinical justification can, in some circumstances, suffice for clinical evidence.

3. Post-market Data

? Provide world-wide distribution numbers of the relevant device
? Include complaint and adverse events reported
? Include complaint and adverse events rates
? Discuss these data to enable an understanding of safety and performance profile
Let us know how you go!
 
M

medic61

Medwise: Thanks for the detailed data! One thing I am stumbling with is how to tie the Esstential Requirements into the Lit Report, anything to offer?
 

Marcelo

Inactive Registered Visitor
As noted in Annex X of the MDD, clinical data is used:

As a general rule, confirmation of conformity with the requirements concerning the characteristics and performances referred to in Sections 1 and 3 of Annex I, under the normal conditions of use of the device, and the evaluation of the side-effects and of the acceptability of the benefit/risk ratio referred to in Section 6 of Annex I, must be based on clinical data.

So, you would need to link your clinical data with the performance claims and side-effects related to those ERs.
 
M

medic61

Thank you Marcello, that makes sense. My predecessor did not refer to the ER by section, just lumped them all together in one statement which was not liked by the Auditor. I wish I understood the ER better, my life would be so much easier!!
 

medwise

Involved In Discussions
medic61: You can use the conclusion section of CER to address requirements you mentioned.

Example –

The following Risk Management Components were considered: Post Market Surveillance through the Complaints Analysis Process, (Document#), Corrective Actions in accordance with Complaints Analysis Process, Corrective Actions in accordance with Corrective and Preventive Action Policy, (Document#), Corrective Actions in accordance with management standing goals in QSDXXX, Preventive Action Investigations in accordance with (Document#) and the Clinical Evaluation Report.

The data presented in this Clinical Evaluation Report indicate that the applicable devices are to be accurate and representative of the current state of the art of Device Name. The data found in the clinical literature support the safety and performance of Device Name for their main indications for use.

o The clinical evidence demonstrates conformity with the essential requirements.
o The performance and safety of the device as claimed have been established.
o The risks associated with the use of the device are acceptable when weighed against the benefits to the patient.

We have reviewed and evaluated current, relevant clinical studies, post-market surveillance complaint data, and independent/internal bench testing results in accordance with Essential Requirement 6a of the Medical Device Directive (93/42/EEC), MEDDEV-Document 2.7.1, and EN 14155. We have carefully considered whether each data source has conformed to the pertinent essential requirements of the MDD.

We are confident that the risk analyses done for these products have considered the intended uses of the devices, the various techniques and technologies that are available in the field, and that the specific attributes of our devices were evaluated against any known risk that they may pose to patients, medical staff, and the environment at large.

Please keep us posted on how your CER shapes up!
 
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M

medic61

Thank you Medwise. Now it all makes sense. I am not new to this but over the years I was not keeping up too well.
 

Marcelo

Inactive Registered Visitor
Example ?

The following Risk Management Components were considered: Post Market Surveillance through the Complaints Analysis Process, (Document#), Corrective Actions in accordance with Complaints Analysis Process, Corrective Actions in accordance with Corrective and Preventive Action Policy, (Document#), Corrective Actions in accordance with management standing goals in QSDXXX, Preventive Action Investigations in accordance with (Document#) and the Clinical Evaluation Report.

The data presented in this Clinical Evaluation Report indicate that the applicable devices are to be accurate and representative of the current state of the art of Device Name. The data found in the clinical literature support the safety and performance of Device Name for their main indications for use.

o The clinical evidence demonstrates conformity with the essential requirements.
o The performance and safety of the device as claimed have been established.
o The risks associated with the use of the device are acceptable when weighed against the benefits to the patient.

We have reviewed and evaluated current, relevant clinical studies, post-market surveillance complaint data, and independent/internal bench testing results in accordance with Essential Requirement 6a of the Medical Device Directive (93/42/EEC), MEDDEV-Document 2.7.1, and EN 14155. We have carefully considered whether each data source has conformed to the pertinent essential requirements of the MDD.

We are confident that the risk analyses done for these products have considered the intended uses of the devices, the various techniques and technologies that are available in the field, and that the specific attributes of our devices were evaluated against any known risk that they may pose to patients, medical staff, and the environment at large.

The only problem with this is that it?s too generic.

As mentioned in the directives, clinical data is used to support very specific ERs, so your clinical data should be linked to those.
 
M

medic61

Thanks for mentioning that. After my reply to medwise I was re-reading my audit notes and seen where I had noted ER compliance to sections were requested by the auditor. I believe sections 1, 2 and 6 were quoted.
Once again, Thanks!
 
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