Navigating the IVDR Transition: What Private Label Manufacturers Must Know

With the implementation of Regulation (EU) 2017/746 (IVDR), the regulatory framework for in vitro diagnostic medical devices (IVDs) in the EU has undergone a substantial transformation. For Private Label Manufacturers (PLMs), this shift has redefined legal responsibilities, particularly regarding technical documentation (TD), quality systems, and contractual relationships with Original Equipment Manufacturers (OEMs). 

At BioBoston Consulting, we support medical technology companies in adapting to these evolving requirements—ensuring IVDR compliance while maintaining operational efficiency and accelerating time to market. 

 

From IVDD to IVDR: A New Era for PLMs 

Under the former Directive 98/79/EC (IVDD), PLMs often relied on OEMs for technical documentation and compliance activities. This practice was loosely defined, with few devices subject to Notified Body review and minimal scrutiny of PLM-OEM agreements. 

With Article 2(23) of the IVDR, the definition of a “manufacturer” has broadened to include PLMs, making them fully responsible for compliance. Article 10 of the IVDR now explicitly outlines the manufacturer’s obligations, including ownership and oversight of the full technical documentation as per Annex II and III. 

This regulatory clarity demands that PLMs take a more proactive, structured approach to IVDR conformity assessment. 

 

Key Steps PLMs Must Take for IVDR Compliance 

To navigate this regulatory shift effectively, PLMs should take the following actions: 

1. Revise and Strengthen OEM Agreements

Establish clear, written quality and data-sharing agreements with the OEM to: 

• Secure full and ongoing access to IVDR-compliant technical documentation 

• Clarify roles and responsibilities for design changes, risk management, and clinical evidence 

• Protect sensitive intellectual property while meeting regulatory obligations 

2. Implement and Align Quality Management Systems (QMS)

As the legal manufacturer, the PLM must implement a QMS that aligns with Article 10(8) of the IVDR. In addition: 

• The OEM’s QMS must also be IVDR-compliant 

• Both parties must ensure consistent documentation practices, especially for design, production, and post-market surveillance 

 

Technical Documentation: What PLMs Must Own and Control 

Holding and maintaining complete, up-to-date technical documentation (TD) is no longer optional. PLMs must ensure the following key elements are in place and align with Annex II and III of the IVDR: 

Risk Management 

PLMs must: 

• Establish a full risk management system as per Annex I, Section 3 

• Integrate OEM-provided risk assessments with PLM-led analyses 

• Finalize a benefit-risk analysis incorporating all residual risks across both manufacturing parties 

• Document how risks are monitored, mitigated, and reviewed collaboratively 

Clinical Evidence & Performance Evaluation 

As per Article 10(3) and Annex XIII: 

• The PLM must prepare a Performance Evaluation Plan (PEP) and Performance Evaluation Report (PER) 

• Evidence must align with GSPRs 1, 8, and 9, and be up to state-of-the-art standards 

• A Post-Market Performance Follow-up (PMPF) plan must be included unless a justified exemption is documented 

• Clarify in OEM agreements how clinical and analytical performance data will be sourced, shared, and verified 

Batch Release Files & Quality Control 

Ensure: 

• Agreements permit access to batch release files and test results 

• The PLM can verify that every batch meets set acceptance criteria before market release 

 

IVDR Transition Challenges: From OEM Dependency to Full Manufacturer Responsibility 

Unlike under the IVDD, the IVDR no longer allows PLMs to rely on the OEM for maintaining control over device compliance. Now, PLMs must: 

• Be audit-ready at all times 

• Retain direct access to all required documentation 

• Act as the sole responsible manufacturer in the eyes of Notified Bodies 

Without robust agreements and documentation in place, PLMs risk significant delays or rejection during the conformity assessment process. 

 

Why Partner with BioBoston Consulting? 

At BioBoston Consulting, we help IVD manufacturers, PLMs, and OEMs navigate complex regulatory landscapes with clarity and confidence. From IVDR transition strategy and QMS alignment to technical documentation audits, we provide the support needed to meet your obligations and accelerate compliance. 

✅ Ensure your PLM agreements meet IVDR expectations 

✅ Close gaps in your technical documentation 

✅ Align QMS across OEM and PLM functions 

✅ Prepare for Notified Body review with confidence 

 

📞 Ready to Get IVDR-Compliant? 

Do not risk your market access. Contact BioBoston Consulting today to schedule an IVDR readiness review with our regulatory experts. Whether you are transitioning from IVDD or preparing for initial IVDR conformity assessment, we help you move forward—faster, smarter, and fully compliant. 

👉 Contact BioBoston Consulting to begin your IVDR compliance journey today.