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CE Marking of Own Brand Label Devices

Manufacturer Benefits and Requirements

Companies often seek to rebrand existing medical devices and sell them under their own name. This process is called Own Brand Labeling and offers faster market entry for companies wishing to build and complete their product portfolio compared to developing a new product.

The regulatory status of an Own Brand Labeler (OBL) continues to cause confusion, as discussed in the May issue of the Journal of Medical Device Regulation. The European regulation, similar to regulations in countries such as the U.S. and Canada, considers the OBL the legal manufacturer even when the OBL has nothing to do with the actual manufacturing or design process. As a result, the regulation holds the OBL to conform to legal and technical requirements over which it arguably has little to no control. This proves to be counterintuitive and problematic with many companies who may not have bargained for the extra responsibility. Moreover, specific approaches remain in the individual European member‐ states and other international regions.

This month’s newsletter explores the OBL process, including how LNE/G‐MED works with its clients to assist in the OBL procedure to understand the requirements to secure CE marking.

Specific areas covered include:

  • Responsibilities of the OBL and OEM
  • Role of the Notified Body
  • Situations where a lighter OBL approach apply

The OBL is the “manufacturer” of the product when a product is labeled with the OBL name and contact information. As a result, the OBL assumes the corresponding “manufacturer” responsibilities according to the applicable European Directive.

The Directives explicitly state that the manufacturer is responsible for the design, manufacture, packaging and labeling of the device, regardless if these operations are carried out by either the company or on its behalf by a third party. The Directive expects the OBL to address all relevant requirements related to product design and the quality management system. Therefore, qualifying the OBL as a “virtual manufacturer” or “distributor” is misleading, giving the false idea that the OBL has less regulatory responsibility than a manufacturer actually making the products. This is not, in fact, the case.

Responsibilities of the OBL and the OEM

The OBL is different from the Original Equipment Manufacturer (OEM), or the manufacturer that actually, physically (as opposed to virtually) manufactures the device. As a result, the OBL and OEM have slightly different responsibilities with regards to the Directives and the device. The OBL must satisfy the requirements for the device’s class and assessment route for the CE marking (annex(es) of the Directive) to apply the CE Marking on the product. Typically, a technical document must exist and a Quality Assurance System implemented if it is required. Obviously this covers the device’s distribution, marketing and post‐market activities, such as post‐market surveillance and complaints. Less obvious is that the OBL is directly responsible for following the regulations regarding design, manufacture and other aspects normally handled by the Original Equipment Manufacturer (OEM). The OEM, however, has the most direct expertise and experience with a device’s intrinsic characteristics. While the OBL is allowed to delegate these activities, it still has the direct responsibility relating to these aspects of the finished device. Because of the linked responsibilities, transparency is necessary between both parties to ensure access to all relevant information for the compliance demonstration. A contract between the OBL and the OEM is essential to clarify the role of both parties and to specify modalities for communication and access to critical information. For example, since the OEM designed the product, it may consider some information proprietary and want to restrict access to the most sensitive parts. This could create problems for the OBL if it does not have complete information about the product during the compliance demonstration.

CISPR 22

Information Technology Equipment – Radio Disturbance Characteristics – Limits and Methods of Measurement. This is one of the better – known CISPR standards. This CISPR standard covers the requirements for radiated and conducted emissions for Information Technology Equipment (equipment that transmits/receives digital data via wire). Measurement techniques are given in CISPR 22 for conducted common mode emissions testing on AC Mains and telecommunications cables. The original standard was released in 1985. Several revisions have been release since that time.