Optimizing PLM-OEM Collaborations: Key Strategies for a Smooth IVDR Transition

Under Directive 98/69/EC (IVDD), it was common practice for in vitro diagnostic medical devices to be placed on the European market under contractual agreements between a Private Label Manufacturer (PLM) and an Original Equipment Manufacturer (OEM). Although the IVDD clearly required manufacturers to keep technical documentation (TD) for their devices, PLMs often did not hold all of it. The Directive did not clearly define the roles of economic operators, nor did it specify the requirements for the content of a TD. Above all, most IVDD devices were not subject to conformity assessment by a notified body under IVDD. As a result, PLMs often had no written quality agreement with their OEM, leading to limited or non-existent access to all documentation.   When providing the definition of a “manufacturer”, Article 2(23) of Regulation (EU) 2017/746 (IVDR) now explicitly mentions activities such as repackaging within the scope of a manufacturer, thus making no distinction between PLMs and other manufacturers. In addition, the manufacturer’s obligations are now clearly set out in a single article of the Regulation (Article (10)), bringing greater scrutiny to the level of control a manufacturer must exercise over the TD. These obligations include creating and updating the device’s TD, ensuring it meets the requirements of the IVDR and comprises the elements specified in Annex II and III of the Regulation. These formal requirements render the traditional concepts of OEM-PLM commercial configurations more challenging, as the OEM is now expected to transmit the TD to the PLM, so that it can be made available to the Notified Bodies at any time.

To best prepare for transition to IVDR, PLMs should consider undertaking the following activities: 

• The first step is to review and revise their contractual agreements with the OEM, to ensure that they cover the ongoing sharing of all complete and up-to-date TD required for conformity assessment purposes (i.e information required as per Annex II and III of IVDR). As this involves the exchange of sensitive data that could form the basis of intellectual property protection, the time required to update the agreements with the OEM should not be underestimated. Importantly, these contractual agreements should further clarify the roles and responsibilities for the management of design changes.  
• As a legal manufacturer, a PLM must have put in place an appropriate quality management system (QMS) that meets all relevant minimum requirements in accordance with Article 10(8) of the IVDR. In addition, the PLM must ensure that all activities carried out at the OEM level are also covered by an appropriate QMS in line with the IVDR.  
• Once the OEM has granted full access to the TD, it is recommended that the PLM undertakes a review of the documentation to identify any gaps in relation to IVDR requirements that need to be addressed prior to conformity assessment. 

As far as the content of the TD is concerned, particular attention should be drawn to some critical aspects:  

• Risk management: The PLM, as the legal manufacturer of the IVD to be placed on the market under its own brand name, shall, in accordance with Article 10(2) of the IVDR “establish, document, implement and maintain a system for risk management as described in Section 3 of Annex I”. The implementation of risk management documentation will require some adjustments, as it must enable PLM to establish a final benefit-risk ratio for the device, taking into account not only the risks associated with its own activities, but also those identified by the OEM with regard to design and manufacturing. These risks have been addressed by the OEM under a different QMS procedure, potentially with a different risk management approach. The PLM must therefore have a risk management procedure and plan in place explaining how it manages the analysis of all identified risks, in order to produce a risk management report that enables all residual risks to be discussed on the OEM and PLM side, both individually and jointly, to conclude on the final benefit-risk ratio of the device. For smooth implementation, OEM and PLM risk management responsibilities should also be addressed in contractual agreements.  

• Clinical evidence: It is also the manufacturer’s obligation to “conduct a performance evaluation in accordance with the requirement set out in Article 56 and Annex XIII, including a PMPF” (Article 10(3)). As the requirements for demonstrating performance have been strengthened compared with the Directive, PLM must ensure that its TD contains a performance evaluation plan (PEP) and report (PER), which specifically allow to positively address GSPR1, GSPR 8 and GSPR 9. In this process, PLM must verify that all available performance data conforms to the latest state-of-the-art, including the requirements of Common Specifications, where applicable, and/or relevant applicable standards and/or state-of-the-art guidance documents. Unless duly justified otherwise, PLM must also draw up a PMPF plan as referred to in Part B of Annex XIII. Contractual agreements need to clarify the roles of the OEM and PLM in terms of V&V data, particularly when it comes to generating IVDR-compliant analytical and clinical performance retrieving all the clinical evidence needed to demonstrate device performance and safety.

Contractual agreements between the PLM and the OEM must also allow for the sharing of batch release files, including quality control tests for each batch of devices, demonstrating that the devices meet the set acceptance criteria, so that the PLM can proceed with the final release of the device before it is placed on the market.  In summary, the transition from the Directive to Regulation (EU) 2017/746 (IVDR) significantly redefines the roles and responsibilities of PLMs, aligning them with those of traditional manufacturers. To successfully navigate this new regulatory environment, it is essential that PLM manufacturers focus on a few key areas before proceeding with the conformity assessment of their device under IVDR: Establishing clear and comprehensive agreements with OEM, that address the roles and responsibilities of both parties, including those related to design changes, and ensuring access to all relevant TD required for conformity assessment; strengthening QMS to meet heightened requirements, as well as maintaining robust and IVDR-compliant risk management and performance evaluation processes and documentations in place.