In many ways, a CE Certificate is a passport to the European Market for any medical device. It provides definitive proof that manufacturers and their products adhere to all European compliance regulations and that all standards have been met at each stage of the production process. The certificate itself ensures only the highest quality, safest products reach the EU marketplace. It is, however, not just a badge of honour for manufacturers and products, it’s also a mandatory requirement for distribution and sales within Europe. This is true for both Original Equipment Manufacturers (OEMs) and Original Brand Labelers (OBLs).
It’s a common misconception that Original Brand Labelers (OBLs) can use their Original Equipment Manufacturers’ (OEM) CE certification to grant them access to markets within EU member states. This is certainly not the case. If anything, the opposite is true. To understand this, we will define the roles of both OBLs and OEMs.
Original Equipment Manufacturer (OEM): An OEM is a manufacturer or company whose main practice is the production and supply of equipment intended to be sold by another company under a brand name unrelated to the manufacturer. While it can be beneficial for an OEM to have its own CE certification, it is extremely unlikely to place any actual products on the market under its own trade name.
That being said, attaining a CE certificate should still be a priority for many OEMs. The holding of such an accreditation makes a product far more attractive to OBLs knowing that it has already passed EU regulatory standards and is market-ready. It can also speed up an OBLs compliance and notificationprocesses immeasurably as the product will not need reassessment.
Original Brand Labeler (OBL): An OBL is very much the other side of the coin to an OEM. The main practice of an OBL is the purchase of equipment manufactured by other companies for resale or incorporation under its own trade name. Generally speaking, an OBL will be the one introducing a product to the market.
With this understanding of the unique role played by each body, it is clear that (under EU Medical Device Directive 93/42/EEC), as the one placing the product on the market, the OBL is solely responsible for acquiring a product’s CE certification from the relevant Notified Body (or by completing pre-market notification for Class i). As such, they cannot rely or operate on the CE certification of any other body.
For more information on the intricacies of MDD directives and regulations within Europe, the compliance process, EU market introduction, or for more specialized advice from our team of regulatory experts, contact Obelis today!