Requirements and Responsibilities for Private Label Manufacturers (PLM)
The Medical Device Regulation (MDR) requires in Article 16 that manufacturers of medical devices have full access to the technical documentation. In addition, Notified Bodies explicitly point out that manufacturers cannot fulfil their obligation to maintain complete technical documentation and/or a quality management system merely by referring to the documentation of a supplier.
As a result, traditional OEM–PLM arrangements are now permitted only to a very limited extent. However, many OEMs are unwilling to disclose their complete documentation.
As a certified manufacturer, we have long held an EU certificate in accordance with the conformity assessment procedure under Annex IX of the MDR and take a different position on this matter. We work closely with our distribution partners to ensure they can continue to place products on the market without restrictions.
Furthermore, we can act as a second source when needed. Having an additional supplier is of great importance in the procurement of medical devices, as it increases supply chain security, reduces the risk of supply shortages, supports production continuity, strengthens negotiating power, and significantly decreases dependence on a single manufacturer.
Please feel free to contact our Regulatory Affairs team. We are happy to support you in preparing the approval process for your new, high-quality endoscopes.