Which documents are suitable as proof of fulfilment of the exemption criteria for a submission of a request for waiving the authorisation of a clinical investigation or a performance evaluation study?

The classification according to Annex IX of Directive 93/42/EEC must be presented in detail as proof that the medical device is a class I medical device or a non-invasive medical device of class IIa (Section 7 sub-section 1 no. 1 or no. 2 MPKPV). The classification must be based on the intended purpose of the device to be declared by the manufacturer.

In the case of medical devices which may bear the CE mark and are used within their intended purpose declared by the manufacturer, but whose clinical investigation includes additional invasive or other burdensome examinations (Section 7 sub-section 1 no. 3 MPKPV), the CE certificate and/or the declaration of conformity should be submitted. As proof of the intended purpose, the instructions for use have to be presented. The additional invasive or other burdensome examinations in the clinical investigation are to be described. Submission of the CE certificate of the Notified Body is sufficient as proof for the validation of the manufacturer’s sterilisation procedures or information on preparation and sterilisation procedures to be carried out by the investigating site in accordance with Section 7 sub-section 2 no. 3 MPKPV.

In the case of in-vitro diagnostics used for performance evaluation studies in accordance with Section 24 sentence 1 no. 1 and 2 MPG (Section 7 sub-section 1 no. 4 MPKPV), it must be proven that

• an invasive sampling is performed exclusively or to a significant further extent for the purpose of the performance evaluation study of an in vitro diagnostic medical device (Section 24 sub-section 1 no. 1) or
• additionally invasive or other burdensome examinations are carried out within the scope of the performance evaluation study (Section 24 sub-section 1 no. 2)
• AND the results obtained in the performance evaluation study will NOT be used for diagnostic purposes without being validated by established methods.

With regard to an assessment of additional invasive or burdensome examinations, the BfArM recommends seeking advice from the competent ethics committee before submission of a request for waiving the authorisation of a clinical investigation or a performance evaluation study.
BfArM reserves the right to request further documents to verify compliance with the exemption criteria. A detailed description of the intended use of the medical device in the clinical investigation can be helpful and should therefore be attached to the application. It may also be part of the risk assessment summary to be submitted in accordance with Section 7 sub-section no. 1 MPKPV.

What is meant by a risk assessment summary (according to Section 7 (2) no. 1 MPKPV)?

A risk assessment summary should summarize the risks associated with participating in the clinical investigation / performance evaluation study as well as the risks caused by the medical device. These should be presented and weighed against the benefits of participation in the clinical trial.

Finally, a justification as to why the benefits outweigh the risks has to be included.

Note on clinical trials with medical devices according to Section 7 sub-section 1 no. 3 MPKPV (submission of a request for waiving the authorisation of a clinical trial or a performance evaluation study):
When submitting a request for waiving the authorisation of a clinical investigation with CE-marked medical devices, the risk assessment summary provided by the sponsor in accordance with Section 7 sub-section 2 no. 1 MPKPV may be limited to the risks arising from the medical device to be tested.