In this article, we are going to describe what can we do about OEM – PLM under MDR.
There are several ways to do OEM under MDR. But first of all, let’s make clear some definitions to get to know better this subject.
OEM: Original Equipment Manufacturer
OES: Original Equipment Supplier
OBL: Own Brand Labeling
PLM: Private Labeling Manufacturer
VM: Virtual Manufacturer
Although there is more than one definition for a situation, there are two positions: A position that manufactures the product, another position that brings the product to the customer.
We are going to use OEM and PLM defitinitions in the next sentences.
Before MDR, notified bodies were auditing both OEM manufacturers and the PLM companies. PLM companies were buying finished products from the manufacturer by putting their own brand on them.
According to Article 10;
4. Manufacturers of devices other than custom-made devices shall draw up and keep up to date technical documentation for those devices.
This means that legal manufacturer must have the technical documentation under his control.
This model is already backed by MDR. According to MDR Article 14 and 16, you can use this model as a method but under certain conditions:
E.G.
Before making a device available on the market, distributors shall verify that all of the following requirements are met:
*ADVANTAGE: PLM company does not need to have an EC Certificate and thus no more cost of certification.
*DISADVANTAGE: OEM company name will become known.
This model is also backed by MDR. New legal manufacturer is going to be PLM company. All manufacturer obligations under MDR have to be fulfilled by PLM company whatever they are.
And also the OEM company must grant full access to the technical file. This will expose the confidential information of the OEM company like critical know-how’s.
*ADVANTAGE: No more cost of certification for OEM company (but the PLM company may require the costs to be split in half).
*DISADVANTAGE: Full access to the OEM product technical file.
In this scenario, the PLM Company is the legal manufacturer of the device on the label and no any other company is mentioned. The OEM company supplies the PLM company with all documents except confidential documents and keeps them up to date at all times. When considering an audit, this is about to split the documents as confidential and non-confidential. Notified body audits the “Virtual Manufacturer” (PLM) as a legal manufacturer and when it comes to review the technical file (or any other related documents), OEM company shows NB the its confidential documents.
*ADVANTAGE: All legal obligations and post-market activities belong to PLM company.
*DISADVANTAGE: MDR compliance is not sure (have to deal with NB). You will need to prepare a procedure which documents are confidential, how you will split them and how you will share them with NB.
The OEM company provides all required documents to the PLM company and encrypts the confidential documents. The password is provided for NB and they will open the documents when auditing. The NB reviews the documents with this password.
*ADVANTAGE: All legal obligations and post-market activities belong to PLM company.
*DISADVANTAGE: MDR compliance is not sure (have to deal with NB). You will need to prepare a procedure which documents are confidential, how you will encyrpt them and how you will give the password to the NB.
The OEM company is going to act like a supplier. They are going to give full access to the technical file and they will sign a Non-Disclosure (ND) Agreement with the PLM company so that company secrets are not shared with third parties. The PLM company will also sign a supplier contract with the OEM to ensure the systematicity and quality assurance of production.
*ADVANTAGE: Nothing against the MDR.
*DISADVANTAGE: The security of all company secrets will be compromised.
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