In the medical-device world, within the Medical Device Regulation, previously certified products are often being bought by companies with the intention to bring them onto the European market under their own trade name. This is commonly known as bringing a product onto the market under private label or plainly private labeling. Whereby the Original Equipment Manufacturer (OEM) is the party from which the product is bought and the private labeler is the party that brings the product under their own trade name onto the European market.
The essence of private labeling is bringing a product onto the market that already has been brought onto the market by another party. This does indicate that the product is compatible with the applicable legislation, as this is compulsory. Additionally, the private labeler saves time and production costs as the product is not developed and produced by himself.
If the involvement by the Notified Body is necessary, it requires an assessment of the technical documentation. In the past it was sufficient to inform the Notified Body that the technical documentation is present at the OEM. In that case, as a private labeler, you did not need to physically have the technical documentation of the OEM.
As the private labeler brings the product onto the market under their own trade name, they are legally the manufacturer. This means that the private labeler is equal to the manufacturer and therefore has the same obligations in accordance with the applicable legislation.
In accordance with the MHRA statement of March 2017 on private labeling, it has been determined that ‘private labeling’ has been replaced by the term ‘virtual manufacturing’. This means that all virtual manufacturers must hold the full technical documentation of any product they place on the European market under their tradename. This sharpens the requirements and make the virtual manufacturer completely identical to the manufacturer in accordance with the legislation.
In theory private labeling does not exist anymore and has been replaced by virtual manufacturing. However, in practice the term private labeling is still alive and is very much used in the medical device world. Private labeling has become a renewned concept.
CE Medical can fully assist your business when you decide to bring a medical device onto the European market under your own tradename. If you have any questions regarding the private labeling of medical devices, please do not hesitate to contact us via our contact form, telephone +31 (0)85 007 3210 or via e-mail email@example.com.
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