CE Mark

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EU 93/42/EEC directive which is published by the EU Commission covers 80% of the medical products sold within the European Union. It provides a basis for the medical device market in the EU together with IVD and AIMD directives. The latest revision published by the EU Commission (2007/47/EC) tried to find solutions some basic issues within the market.

However, the EU commission in line with ongoing problems and safety issues within the sector in recent years has started to work on a comprehensive revision of the medical device directives. New regulation, which will include though requirements for manufacturers and notified bodies is expected to come into force during summer of 2016. You can contact us to prepare your quality management system and product technical file based on the new conditions at bizesorun@13485.info

The Current Directive (93/42/EEC)

The main purpose of the 93/42/EEC directive is to ensure the safe use of medical devices by patients and users. It provides a regulatory basis for the manufacturers like an insurance policy which includes technical and safety requirements. The directive offers a variety of conformity assessment procedures for CE marking of medical devices by defining a risk classification according to the intended use of the medical device. The rules given in the ninth annex defines the directive defines the risk groups as class I, Im, Is , IIa , IIb and III. Conformity assessment procedures have been defined for each group.

According to 93/42/ EEC directive, appropriate conformity assessment procedure for a medical device can be defined by answering the following four questions;

  • Is my product a medical device according to the medical device definition of the directive?
  • According to the rules set out on Annex 9, to which risk group does it fall into?
  • According to the risk level of my device, which conformity assessment procedure is appropriate?
  • How shall I structure the technical documentation for my medical device?

For as determination of the risk class, to get more detailed information about the identification of the most appropriate conformity assessment procedure for your product, please contact us directly through bizesorun@13485.info