Medical Device Classification not Centrally Stored

A recent discussion with the MHRA has provided enlightening:

At present no single organisation holds details of all medical devices – there are plans for the creation of a European Database, however these are not yet in place.

The medical device regulations differ from the medicines regulations in that no ‘licence’ is issued by any EU Competent Authority as is the case for medicinal products. A medical device may be CE marked in one Member State and then freely placed on the market in any other Member State. The requirements under the medical device directives are for the manufacturer to demonstrate the products conformity to the requirements and to CE mark the product. The Directives require that Class I medical devices and in vitro diagnostic medical devices are registered with the Competent Authority in which the manufacturer or his authorised representative is based, however all other classes of medical device are CE marked via a duly designated Notified Body, who again may be located in any EU Member State. The Notified Bodies are responsible for confirming that the devices meet the requirements of the regulations and once this has been done by issuing a CE certificate to the manufacturer for the devices concerned.

All manufacturers of medical devices will provide details of their products classification and CE marking conformity route to each EU Competent Authority for medical devices upon request,  however this information may only be requested when there is reason to believe that the product concerned is not in conformity with the requirements of the medical device directives. Manufacturers are not obliged to provide this information to other third parties, although some are happy to do so or provide details on their websites.

Damien Bové works as a drug development consultant (pharmaceutical or biotechnology) and regulatory consultant, we work with our clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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