Within the MDD, UK government already decided. But what will happen to the new Medical Device Regulation? This is a recommendation, so not all Notified Bodies are following this for now. To clarify this sentence, it means that the OBL cannot just claim that the Technical File is with the OEM.
Own brand labeller full#
Notified bodies should note that manufacturers: ĭo not fulfill their obligation to have at their disposal the full technical documentation and/or of a quality system by referring to the technical documentation of a subcontractor or supplier and/or to their quality system There is a specific chapter called “General advice in case of outsourcing of the production via subcontractors or suppliers”īelow is an extract from this chapter where it clarifies the attitude of the Notified Bodies regarding products outsourced by critical subcontractors or crucial suppliers. On September 24th, 2013, a recommendation from the European Commission was published under the number 2013/473/EU. Then they can market it under their brand without mentioning to its customers that this product is in reality manufactured by an OEM. The OBL companies will use the CE certificate of the OEM to get their own CE Certificate for the product. Then he will propose his products to some medical device companies call OBL. On the image below you can see that first the OEM should get a CE Certificate from his own Notified Body. The only change will be the label information with now the OBL trade name. The only condition is for the OBL to not modify the products coming from the OEM. And additionally, he should also create an abbreviated Technical File to be used by the Private Labeler. The Own Brand Labeler, or Private Labeler who should appoint also a Notified Body, uses the OEM certificate to justify that the product is compliant with the European Regulation. The OEM is the manufacturer of the product and should have a CE certificate for its products coming from its own notified body. If you need any help or advice, just give us a call on 01332 865933 and we will be happy to help you in any way we can.With the Medical Device Directive 93/42/EC, this was clear.
Own brand labeller free#
If your label gun becomes damaged or unreliable, simply send it back to us and we will service it free of charge (or advise you if it is beyond economic repair) – just give us a call to tell us that you are sending it! We will service your 2 line price gun free of charge if you are having any difficulties.
Unlike our competitors we are proud to provide full support with all the 2 line label guns. All 2 line price guns and hand gun labellers are held in stock and are available for dispatch on the same day of your order. We are proud to be an industry leader in the price gun and labelling gun business with over 20 years of experience at your disposal.ĭanro’s 2 line price gun range includes our own brand Danro price guns as well as Swing price guns and Open Data price guns. Our products are all manufactured to the highest standards using high quality materials and processes.
Ideal for batch coding and multiple date indicators, 2 line label guns provide for a wide range of applications. Danro provide a range of 2 line price guns for use in retail and other industries.
0 kommentar(er)
