Obelis S.A., O.E.A.R.C.

Update Medical Devices Directive 93/42/EEC - Clinical Evaluation

In reference to the recent changes to the MDD 93/42/EEC by its amendment the 2007/47/EC, the following needs to be brought to your attention:

1. All classes of Medical Devices will require “clinical data.”
2. Confirmation of conformity must be based on clinical data.
3. The clinical evaluation and its documentation must be actively updated.

1. One of the important changes refers to Essential Requirement 14 from the MDD 93/42/EEC Annex I which will be deleted. As a consequence all classes of medical devices will require “clinical data” (as a part of the technical file), including “Class I.”

2. According to Annex X, confirmation of conformity with Essential Requirements 1, 3 and 6 must be based on clinical data (hereinafter ER 1, 3: Demonstration of conformity with requirements concerning characteristics and performances; ER 6: Evaluation of undesirable side effects and of the acceptability of the risk/benefit ratio). Clinical data means the safety and/or performance data that is generated from the clinical use of a device and must include data obtained from any of the following:

• (un)Published data on clinical experience with the device or equivalent;
• Clinical investigation;
• Clinical investigation with similar device;
• Combination of the above.

3. Manufacturers will have to document further evidence of compliance through clinical evaluation of clinical data in a more permanent way (“PMS” clinical evaluation). The clinical evaluation and its documentation must be actively updated with clinical data obtained from the post-market surveillance. Clinical evaluation will have to be based upon:

• Compilation of relevant scientific literature and a written critical evaluation
• The results of all clinical investigations and a written critical evaluation.

Furthermore, in congruence with the above, clinical investigation (MDD 93/42/EEC – Annex X) has to be notified to the Competent Authorities where the clinical investigation has to be conducted, after a “green light” from an “Ethical Committee” – MDD 93/42/EEC, Annex VIII. This notification can be performed either by the manufacturer, his appointed sponsor or a European Authorized Representative. None the less, once clinical investigation is performed within the European market, any incident during the Clinical investigation MUST be reported ONLY through the appointed European Authorized Representative to the Competent Authorities.
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