OBL Manufacturer under MDR/IVDR – Selling Devices under Own Brand

Who Is an OBL Manufacturer under MDR and IVDR?

An Own Brand Labeling (OBL) manufacturer—also called a virtual manufacturer—places a medical device on the market under its own brand even though it does not physically manufacture it. Under MDR 2017/745 and IVDR 2017/746, the OBL assumes full legal and regulatory responsibility, just like a traditional manufacturer. This includes registering in EUDAMED, signing the EU Declaration of Conformity, and meeting all quality system requirements.

Who Benefits from the OBL Model and When to Use It?

The OBL model is ideal for companies that:

• Build their brand without owning manufacturing facilities,
• Distribute OEM devices under their own name,
• Have strong sales expertise but not in-house manufacturing know-how,
• Act as integrators—adapting products to local regulatory requirements.

However, they must fully assume conformity assessment, documentation, and post-market surveillance obligations.

OBL vs. OEM vs. Traditional Manufacturer—Responsibility Comparison

Technical Documentation & CE Marking Responsibilities for OBL

An OBL manufacturer must hold full technical documentation, including:

• The EU Declaration of Conformity,
• Clinical evaluation, GSPR, and post-market surveillance data (PMS),
• Quality system procedures,
• Risk analysis reports and PMCF.

The OBL signs off on CE marking and conformity documents; the OEM remains unseen by end users.

Step-by-Step OBL Registration in EUDAMED

1. Create a manufacturer account and obtain an SRN in EUDAMED,
2. Register each device and assign its UDI-DI,
3. Notify the Notified Body (if applicable),
4. Update records whenever the OEM, certificate, or design changes.

OBL in IVDR—What’s Different for IVD Manufacturers?

Under IVDR 2017/746, IVD OBLs must consider:

• Risk classes A, B, C, D,
• Performance evaluation instead of clinical evaluation,
• Greater Notified Body involvement,
• PMS requirements even for sterile Class A devices.

IVD OBLs need a tailored regulatory strategy, including reference lab access and specialized certification planning.

OBL–OEM Agreement Requirements

The OBL–OEM contract must:

• Ensure access to full technical documentation,
• Cover production oversight,
• Prohibit unauthorized changes,
• Allow Notified Body audits at the OEM site.

Poorly defined contracts can block or terminate OBL certification.

Actions When an OEM Loses Certification

• Halt distribution immediately,
• Notify your Notified Body and competent authorities,
• Assess alternative OEMs,
• Review and secure technical documentation,
• Implement a corrective action plan.

Every OBL should maintain an emergency continuity plan.

Competitive Advantages of a Well-Designed OBL Model

OBL can accelerate EU market entry if:

• Your OEM partner holds robust certifications,
• Your quality and surveillance processes are solid,
• Your OEM agreement secures document access and certification continuity,
• Your UDI and registration strategy aligns with MDR/IVDR timelines.

How Pure Clinical Supports OBL Manufacturers

• Regulatory readiness audits (checklists, documentation & contract reviews),
• Drafting and vetting OEM agreements,
• Compiling full technical files & conformity assessments,
• Registering your company and devices in EUDAMED, obtaining SRNs & UDIs,
• Preparing for Notified Body audits and authority inspections.

With Pure Clinical, OBL manufacturers achieve compliant, efficient EU market access under MDR and IVDR.

FAQ

Can an OBL manufacturer delegate the preparation of the technical documentation to a third-party expert?

Yes, the OBL manufacturer may outsource the preparation of technical documentation, but retains full legal and regulatory responsibility under MDR/IVDR. Delegation does not transfer liability in the eyes of notified bodies or competent authorities.

What are the risks of not disclosing the OEM in commercial contracts with distributors?

Failing to disclose the OEM may lead to supply chain disruptions, traceability gaps, and challenges in corrective actions during incidents. Transparent communication with commercial partners is a key component of effective risk management.

Is the OBL model applicable for high-risk devices, such as Class III or Class D IVDs?

Yes, but it demands a mature quality management system and close cooperation with a highly competent OEM. High-risk devices require strict conformity assessment procedures, notified body involvement, and enhanced post-market surveillance.

What qualifications should the person responsible for regulatory compliance in an OBL company hold?

The responsible person should have expertise in conformity assessment, deep knowledge of MDR/IVDR, documentation management skills, and experience dealing with notified bodies. Credentials such as RAPS certifications can validate these qualifications.