Product safety and instructions in the EU and US

Request quote → Product Safety in the EU Introduction CE marking The European New Approach Directives form the starting point of the CE marking (Conformité Européenne). CE marking is a key indicator of the compliance of a product with the relevant EU legislation. When a product complies with the applicable EU legislation, the free movement of […]

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American standards regarding instructions for use

Request quote → Directives and standards To remove the barriers to free circulation of goods and to protect consumers and other users of all kinds of products, the European Union has developed, and still develops, tremendous effective instruments. One of these instruments are  the directives as part of the New Approach. These directives contain fundamental […]

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Machinery Directive 2006/42/EC

Request quote → Please note! The scope of the Machinery Directive The Machinery Directive defines machinery as follows: Next to the above descriptions, the Machinery Directive applies to: Several products are excluded from the Machinery Directive, such as fairground amusements, weapons, seagoing vessels and most vehicles. Separate guidelines are written for these kind of products. […]

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New radio equipment directive

Request quote → Article 10  Obligations of manufacturers 6. Manufacturers shall ensure that radio equipment which they have placed on the market bears a type, batch or serial number or other element allowing its identification, or, where the size or nature of the radio equipment does not allow it, that the required information is provided […]

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CE-marking medical software

Request quote → When CE certified, a medical device complies with all European legal requirements regarding safety, health and environment. If the device includes software, this software should also comply with EU standards. For example, the software embedded in a MRI scanner, should also be tested in order for the scanner to receive a ‘medical’ […]

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