Subcontracting Clinical Evaluations

[dionysisf]

Hello,

We are a medical device manufacturer, manufacturing Class IIb products.
Our clinical evaluation study has been produced by us some years ago, using 2 clinical trials and literature assessment.

As we are facing issues with this evaluation study during registrations to non-EU countries and during auditors reviews, we would like to update it and to subcontract it.

Could you please advice us whether we can use a "clinical evaluation" expert/company to perform the clinical evaluation for us? If yes, do you know any company having such expertise?

Thanks in advance

 

[Pads38]

Why do you want to subcontract it out?

If you have existing Clinical Investigation and literature you just need to update the search plus format the report to match the latest MEDDEV guidance document.

http://ec.europa.eu/health/medical-devices/files/meddev/2_7_1rev_3_en.pdf

It is worth understanding that the whole purpose of the Clinical Evaluation is to satisfy the Essential Requirements that cannot be done by other means. This tends to come down to:

The Essential Requirements relevant to this evaluation are:
ER 1 The devices must be designed and manufactured in such a way that ... they will not compromise the clinical condition or the safety of patients ... provided that any risks which may be associated with their intended use constitute acceptable risks when weighed against the benefits to the patient...
ER 3 The devices must achieve the performances intended by the manufacturer...
ER 6 Any undesirable side-effect must constitute an acceptable risk when weighed against the performances intended.
ER 6a Demonstration of conformity with the essential requirements must include a clinical evaluation in accordance with Annex X.

The literature search is readily updated (I use Google Scholar and internal records / market surveillance). It should not need any 'special' knowledge beyond the expertise that you will already possess as device manufacturer.