CE Marking - Medical Devices - Clinical Evaluation to 2007/47/EC

[seank]

Hi,

I am currently trying to write a clinical evaluation report for some Class 1 medical devices that we hold the CE Mark for.

These devices are Class 1 medical devices, and are ancillary devices used for the preperation of drugs, or as an assistance to other Class 1 Medical Devices. (For example, a vented needle for reconsitition of drugs).

The devices have been on sale for 5+ years, with no significant complaints or issues raised.

I am trying to write a clinical evaluation in accordance to the amended Medical Device Directive (2007/47/EC). There is no literature or journals available (to be honest I wouldn't expect there to be), and I don't feel the products warrent a Clinical Trail.

Any suggestions on how to write a clinical evaluation that shows conformity of the device, without performing a Clinical Trail or having any scientific literature available?

Thanks

 

[Roland Cooke]

Hi,

I am currently trying to write a clinical evaluation report for some Class 1 medical devices that we hold the CE Mark for.

These devices are Class 1 medical devices, and are ancillary devices used for the preperation of drugs, or as an assistance to other Class 1 Medical Devices. (For example, a vented needle for reconsitition of drugs).

The devices have been on sale for 5+ years, with no significant complaints or issues raised.

I am trying to write a clinical evaluation in accordance to the amended Medical Device Directive (2007/47/EC). There is no literature or journals available (to be honest I wouldn't expect there to be), and I don't feel the products warrent a Clinical Trail.

Any suggestions on how to write a clinical evaluation that shows conformity of the device, without performing a Clinical Trail or having any scientific literature available?

Thanks

It's a common problem. First of all, do review the existing MEDDEV and NB-MED guidance documentation. Get sight of the relevant section in ISO14155-1 (you can buy a copy or visit your local (university) library).

For a product like yours, you need to prove three things.
a) that these types of devices are in routine use in the clinical environment, and that the clinical benefits are universally agreed.
b) that your device is standard, or that any minor differences are no big deal
c) that any residual risks are outweighed by the benefits, (and that no further design improvements are practical)

Clinical textbooks are a good source of evidence. If you can show that clinicians are taught to use your products, that's a very powerful argument.

 

[thisby_]

Hello!

I have almost the same problem as Seank but my product is a SW medical device class I (a kind of electronic health record). I am having troubles in follow what os written in Annex I Section 6a) "demonstration of conformity with the essential requirements must include a clinical evaluation in accordance with annex X" for the SW case do you have any suggestions in how to do a clinical evaluation document?

Thank you!

Emilia

 

[SteveK]

Hello!

I have almost the same problem as Seank but my product is a SW medical device class I (a kind of electronic health record). I am having troubles in follow what os written in Annex I Section 6a) "demonstration of conformity with the essential requirements must include a clinical evaluation in accordance with annex X" for the SW case do you have any suggestions in how to do a clinical evaluation document?

Thank you!

Emilia

If it is an "electronic health record" wikipedia may be a good starting point.

http://en.wikipedia.org/wiki/Electronic_health_record

 

[thisby_]

Thank you for the replay, usually I don't see wikipedia as a "trust" website to search scientific valid informations, however it has interesting external links.

Emilia

 

[SteveK]

Thank you for the replay, usually I don't see wikipedia as a "trust" website to search scientific valid informations, however it has interesting external links.

Emilia

It was the links I thought you may find helpful also:

For my Clinical Evaluations I have a template which at the beginning quotes the relevant sections of Annex X (i.e. 1.1, 1.1.1, 1.1.2 and 1.1.3).

Then I have a number of sections under ‘Literature Critique’

a. Device Description, function and use
Here you can indicate similar designs out there on the market, the similarity to yours, how long they have been about, history etc. Any data you have generated.

b. Analysis of and references to the literature
It is out there on the ‘ether’ – it just needs a lot of searching (try google books). In this section I cite the references (can also give a brief review here or in the conclusion).

c. Hazards
Can be based on a risk analysis and any ‘Device Alerts’ from regulatory body web sites e.g. MHRA in the UK. http://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/index.htm

d. Conclusion
What have you gleaned from the literature, competitor products etc also indicate customer feedback (re-orders, surveys, complaints analysis etc)

 

[thisby_]

Thank you!

Emilia