ARE YOU CONSIDERING OEM, OBL UNDER MDR?

Описание: Original Equipment Manufacturing (OEMs) or Own Brand Labeling (OBL) concepts are still viable business strategies under 2017/745 MDR. However, MDR Article 10 states that legal manufacturers must have the technical documentation under their control introducing some layers to be discussed for the OEM and OBL model
OEM and OBL model under the old directive (MDD) were straightforward with minimum risk for both partners as OBL company were able to use OEM’s CE certificate to justify the product is compliant and create abbreviated technical documentation. This way, OBL company could market the product without mentioning the OEM company.

Even though MDR and MDD, in principle impose the same obligations, in practice MDR introduced more strict requirements. The OBL company, must have continuous access to the OEM’s technical documentation and prepare their own full technical documentation rather than an abbreviated one as it was acceptable by Notified Bodies under MDD. Hence, all the commercially-confidential information that is part of the technical documents must be shared. Furthermore, requirements regarding post-market surveillance and vigilance activities and product liability are still valid for the OBL as well as other obligations that were set out in Article 10 of MDR regarding the manufacturers.

The costs, responsibilities, and liability originating from the OEM, and OBL models are substantially increasing, hence cost-benefit analysis must be taken more seriously than ever for the parties that are looking to utilize OEM and OBL models for their medical devices.

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