This includes a set of warnings and markings for common hazards, such as sterilization warnings, date of use, and other warnings. A number of symbols have been defined in ISO The symbols in this harmonized standard may be used on the devices without further textual explanation.
Examples of products we assessed successfully are:. We will be happy to provide you with a suitable quote for type testing your equipment according to the MD directive: ask a quote here Non european manufacturers EC REP European Authorized Representative As a non-european medical devices manufacturer you will need to establish a EC authorized representative for your products. The EC REP is a legal entity designated by you to assist in the compliance process, and should be considered as a neutral compliance partner in Europe.
It's main responsibilities are among others : Contact point to the authorities, Assist in product classifications, Carry out the vigilance functions on your products, Keep the Compliance documentation available, Notify and register product as required by the national authorities, Incident reporting and complaint handling within the EC.
You should not appoint any of your commercial representatives, as the name of the EAR will be mentioned on the product label. Follow cetestbv ce-news newsletter. Lieu Dit Pirot Chauffailles France route. Email cetest cetest. Some factors you should take under consideration are: intended to be in continuous use invasive or surgically invasive, implantable, whether or not the device contains a substance. Detailed requirements The test procedures and judgments are generally steered a by a risk analysis approach.
Prepare a risk management file to EN , Obtain sufficient clinical data to obtain proof of claims, Create proof of biological safety, Comply with electrical safety requirements EN series of standards, Comply with electro magnetic compatibility EMC EN series of standards, Create a risk analysis steered reliability report for software to EN , Implement Labeling and Instruction requireme nts and translations, Maintain traceability records on batch or component level, Set up a vigilance system.
Registration Class I Medical Devices need to be registered at a competent authority. Respective to the risk class of the device, there are varying procedures that can be applied. In this respect, it is not important whether a device has been produced within the EU or imported from any country outside the EU.
The involvment of a Notified Body is necessary for all medical devices, except for class I medical devices non-sterile or without a measuring funtion. Product placement on the market cannot be prevented by any EU country if a device caries a CE mark which is a confirmation that this device meets the basic requirements according to Annex 3.
Directive and has undergone the conformity assessment procedures. If this is not the case, the product placement on the market can be prohibited. Consequently, users may experience instabilities and limited functionality. We apologise for the inconvenience. Web Content Display Global. For a better user experience please update your browser or use Chrome or Firefox browser. Publication Detail Actions Portlet. Rate this publication. We would like to hear your views on this material or activity.
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