Medical Device OBL CE Marking

OBL CE Marking of Medical Devices

The world is changing, the market of Medical Device is booming all over the world. Established firms limited to certain area create partnership with other established firms to sell in their brand name in different area and to a wider product range to the benefit of both parties. This practice is known as Private-label manufacturing or own-brand labeling.

The practice is accepted by the European regulatory authorities and is common within the medical device and in vitro diagnostics industry.

It is well understood that the Original Equipment Manufacturer (OEM) and Private Label manufacturer requires CE Mark for marketing in Europe. If OEM products are CE Marked, it is very easy for the OBL/PLM to acquire CE Certificate from reputed Notified Body. Article 2, sec. 30 of the Medical Device Regulations (MDR) and the IVDR give the same definition for "manufacturer".

OBL CE Marking Requirments

  • The PLM as the company whose name is appearing on the final packing has the complete responsibility for that product in compliance with regulatory. Thus the PLM must meet all relevant elements of the MDD and CE Marking of the products.

  • This kind of business and CE Marking, it is important that agreements between the OEM and the PLM cover not just the commercial terms, but also their respective regulatory responsibilities and transfer for updated MDD Compliance documents.