Examples of Medical Device Directive in a sentence
The medical equipment of USA must comply with 510(K) FDA (Food & Drug Administration), in case of Europe MDD (Medical Device Directive) and for Japan MHLW (Ministry of Health, Labour& Welfare) for specific quoted model.
The member countries of the European Union have adopted the European Medical Device Directive, which creates a single set of medical device regulations for products marketed in all member countries.
Compliance with the Medical Device Directive and certification to a quality system enable the manufacturer to place a CE mark on its products.
Article 16d Unless the entrepreneur fulfills the obligations defined in Article 16b(1)-(3), the consumer shall be vested the right to withdraw from the contract at any time without the need to incur the costs due to the entrepreneur.
It shall be duly CE marked to the Medical Device Directive 93/42/EEC under the auspices of notified body no.