Medical Device Directive As I understand it (and our Notified Body) all warning messages on the device, the "basic" operating instructions are required to be translated. We have taken our User Manuals and streamlined them into the basic information required to safely and effectively operate the device, this is called the Operation Guide and is translated. Software is another issue (a gray area it seems), from the marketing side - yes, from the regulatory side ?. If the software has imbedded into it the devices operational instructions this portion would need to be translated. In the case of medical, the minimal amount of information to be provided to the customer is given in Annex I of the MDD (directive and in EN60601-1 Clause 6, this information shall be translated into the native language of the country that the device is offered for sale and use. This is not RTTE directive but I'm sure the directives requirements are similar in some ways. Hope this helps in some way.
-----Original Message----- From: Praveen Rao [mailto:[email protected]] Sent: Monday, January 08, 2001 12:47 AM To: [email protected] Subject: Documents with 'CE' products Dear Members, We are in the process of organising our shipments to various countries in the EU. We have tested and complied with the RTTE directive and understand the CE marking requirements. We had the following doubts wrt to the shipment of the products. Is it legally required to : * Ship product manuals (installation, service and administration) with every product sample. We intend to send manuals only to the distributor in the respective countries and not with every box. If yes, does this legally have to be in the respective national language. We understand that there are 11 official languages in EU. This may be required from 'marketing point of view', but is it a legal requirement as per any directives ? * We have a regulatory document which explains the different approvals (stating compliances with the directive and standards tested to, etc) and warnings we have for Europe, USA, etc. Is there a legal requirement to have such a document stating Compliance with each sample shipped. If yes, does this have to be in a hard copy format in the respective national language. Alternatively, can this document be posted on the website and indicate the access details with the product. Is this legal ? My specific questions are as below. 1. What information (in any format) must we supply (eg. Regulatory document). If any, what are the requirements with respect to format and language? 2 Is there a requirement for us to provide any other information in the native language of the country we sell into? 3 Is there a requirement for any information we supply to be in hardcopy, or is softcopy sufficient? 4 Are there any restrictions or perhaps concessions made for putting information on our website for people to download? Could we for example, put all information on there and have them download all requirements? Your comments please Praveen Rao ------------------------------------------- This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. To cancel your subscription, send mail to: [email protected] with the single line: unsubscribe emc-pstc For help, send mail to the list administrators: Jim Bacher: [email protected] Michael Garretson: [email protected] For policy questions, send mail to: Richard Nute: [email protected] ------------------------------------------- This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. To cancel your subscription, send mail to: [email protected] with the single line: unsubscribe emc-pstc For help, send mail to the list administrators: Jim Bacher: [email protected] Michael Garretson: [email protected] For policy questions, send mail to: Richard Nute: [email protected]
