Notification Procedure for Clinical Investigation

Objective of clinical investigation:

  • To verify that, under normal conditions, the performance of the devices conform with the Medical Device Directive

 

  • To determine any undesirable side-effects, under normal condition of use, and assess whether they constitute risks when weighed against the intended performance of the device.

 

Notification procedure according to MDD 93/42/EEC, articles 15. 1, 2 & 3 andAnnex VIII, 2.2, 3.2 and 4

  • A manufacturer or his Authorized Representative has to notify the competent authorities of the Member States in which the investigation is to be conducted (MDD 93/42/EEC, article 15, 1)

 

  • The manufacturer or his appointed authorized representative must draw a statement before conducting a clinical investigation (MDD 93/42/EEC, Annex VIII, 2.2)

 

  • The clinical trial can only start at the end of 60 days after notification in case of Class III and implantable and long-term invasive devices falling within Class IIa or IIb. However, the competent authority may authorize manufacturer to commence the clinical investigation before the end of the 60 days in case the relevant ethics committee has issued a favourable opinion on the programme of the investigation. (MDD 93/42/EEC, article 15, 1 & 2)

 

  • The clinical trial may start after the date of notification if the competent authority authorizes the manufacturer to do so provided that the ethics committee has delivered a favourable opinion relating to the investigation.(MDD 93/42/EEC, article 15, 3)

 

  • The investigation must be performed under the responsibility of a medical practitioner or another authorized qualified person in an appropriate environment (MDD 93/42/EEC, article 15)

 

  • A report has to be written and signed by the medical practitioner or other authorized responsible person. The report must contain critical evaluation of all the data collected during the clinical investigation.(MDD 93/42/EEC, article 15)

 

  • The information should be kept available for a period of at least 5 years (MDD 93/42/EEC, Annex VIII, 4)

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