Strategic Considerations for Partnering with a Vendor for EU MDR Deliverables
Strategic Considerations for Partnering with a Vendor for EU MDR Deliverables
As regulatory teams navigate the demands of the EU Medical Device Regulation (MDR), many are evaluating how to best allocate their resources. The growing complexity of clinical evidence requirements, combined with the unpredictability introduced by surveillance audits, product launches, acquisitions, and staff turnover, has made it increasingly difficult for regulatory teams to forecast and manage workloads. These variables introduce additional volume with added complications such as urgency and approaching deadlines. These factors can strain even the most well-structured internal teams and potentially lead to additional turnover. In this context, a hybrid resourcing model has become an essential strategy for maintaining compliance without sacrificing agility or quality.
This article outlines key considerations for determining when to retain work internally and when to engage a trusted third-party partner.
Internal Responsibilities: Retaining Control Where It Counts
Certain aspects of EU MDR compliance are best maintained within your internal team. Regulatory strategy, for example, is closely tied to an organization’s long-term market goals, investment decisions, and product roadmap. These discussions require familiarity with a company’s broader corporate strategy and are often informed by a nuanced understanding of historical regulatory interactions and future business objectives. However, not all companies have internal teams with the experience or regulatory familiarity needed to formulate a compliant and forward-looking strategy. In such cases, an experienced third-party partner can play a valuable role in guiding early planning efforts and helping to establish a strong foundation for long-term success.
Manufacturers that have the appropriate resources may choose to build and maintain a core internal writing team when workloads are stable and predictable. An internal writing team can develop deep product-specific expertise that aligns precisely with an organization’s business goals. Writers who are consistently engaged with a specific product family or therapeutic area are better positioned to recognize subtle shifts in clinical expectations, performance trends, or recurring risk factors.
Internal ownership is essential for quality management system (QMS) activities and overall post-market surveillance integration, which demand close coordination across departments and continuous monitoring. Strong internal leadership can better facilitate cross-functional stakeholder communication and coordination. An internal team may be best suited for navigating the business landscape to ensure that all stakeholder functions are best aligned for project success. Furthermore, internal writers with extensive institutional knowledge may be best suited to identify historical challenges associated with individual product lines. This knowledge may be leveraged for future success.
Direct communication with Notified Bodies, particularly when addressing significant findings or coordinating complex CAPAs, also benefits from internal leadership. These conversations often involve real-time decision-making that directly align with current business practices and strategies.
The Case for Outsourcing: When External Support Adds Value
External vendor support can provide your team much-needed relief during periods of elevated workload and/or organizational change. Sometimes, your team may need more time to refocus on new product development; or they may be faced with a particularly challenging NB responses. Adding external support can ensure that your team can meet all urgent demands without sacrificing project momentum or endangering deadlines dictated by your QMS or NB obligations. Considering that CERs, SSCPs, PMCF-Rs, and PSURs all require regular updates, the risk of having an overloaded team of writers can be quite high.
Some documentation areas in which external support can be particularly beneficial include:
Clinical Evaluation Reports. CERs alone can require an enormous investment of time, resources, and expertise. Regular updates can require extensive literature searches, reviews of new clinical data, writing, data analysis, and cross-functional organization and synchronization.
Post-Market Clinical Follow-up. PMCF documentation can be labor-intensive and time-consuming, particularly when it comes to alignment with clinical evaluation and other post-market surveillance documentation. Along with providing high-quality writing and documentation, the right external support team can advise on PMCF activities and strategies to address data gaps in the most cost-effective manner possible.
Other Post-Market Surveillance documentation. Post-market teams may be focused on signal detection, vigilance, and operational reporting, and benefit from external support on technical writing and documentation tasks. As PSURs and PMS Reports require regular updates and alignment with the CER, PMCF-R, and other documentation, enlisting support writers that are familiar with these documents can reduce audit findings and NB questions.
Other scenarios that can benefit from the right vendor support:
Teams with inexperienced writers can benefit from vendor support. The right external partner can perform writing work efficiently, while leveraging deep experience in MDR deliverables. Along with the writing efficiency, the ideal third party support team will have deep familiarity with common Notified Body expectations. A well-qualified third-party can ensure alignment with the most current MDCG guidance and NB expectations, leading to fewer revision cycles and improved submission outcomes.
Urgent disruptions to scheduled workload. Vendor support may be a critical solution in urgent scenarios, such as responding to Notified Body questions under tight timelines, or managing unexpected deliverables stemming from mergers, acquisitions, or rapid product expansion. In these instances, even the most capable internal teams can become overextended, risking delays or lapses in quality. This is when pulling in scalable resources, such as a writing vendor, may allow your team to focus on their priorities while ensuring your business and regulatory goals are achieved.
Template and process creation. Pulling in vendor support also provides value when building document templates. Specialized firms bring current regulatory insight and document production expertise based on their exposure to the regulatory landscape, even beyond topics that the MDCG guidance have addressed. This ensures the output meets expectations from both format and content perspectives.
Making the Decision: A Strategic Framework
The decision to work alongside an outside vendor should not be reactive. Instead, we recommend a deliberate and proactive assessment of your overall scope of work built around five core factors:
First, consider your team’s available capacity relative to the anticipated volume of deliverables in the next 12 to 18 months.
Second, evaluate the complexity of each document. New product development within your organization’s portfolio may require decisions that are best suited for internal writers. Projects that require full remediation may need the dedicated support of external writing partners.
Third, assess time sensitivity. If a deliverable is required to secure market access, respond to a Notified Body, or support a product launch, speed becomes a critical factor. External writing support can typically be leveraged to hit tough deadlines.
Fourth, evaluate the strategic value of the work. Some projects that closely align with your business priorities may be best suited for internal writers with those business insights..
Finally, consider the regulatory risk: submissions with significant consequences for compliance or market presence may benefit from internal project management.
Qualities of a High-Performing EU MDR Partner
Working with a vendor partner introduces its own risks, particularly if the partner lacks regulatory depth or cannot scale responsively. When selecting a third-party provider, ensure they have a documented track record of success under the MDR framework. Redacted sample deliverables can be useful, but they are not always easy to obtain or verify. In many cases, it is more effective to rely on peer referrals or professional networks to identify vendors with a strong track record. Speaking directly with regulatory professionals at other companies who have successfully partnered with a vendor can provide more meaningful insights into quality, responsiveness, and regulatory acceptance.
Scalability is also key. The right partner will be able to deploy additional resources quickly, without compromising quality. Ideally, they will offer integrated management and review to ensure that clients receive accurate, high-quality deliverables.
Quality control is another critical consideration. Each deliverable should be reviewed by both scientific and editorial professionals before submission. The use of AI tools should be transparent and limited to well-defined contexts, always paired with human verification. Finally, communication protocols should be clear. Timely updates, defined escalation pathways, and consistent points of contact are foundational to a productive outsourcing relationship.
Embracing a Hybrid Resourcing Model
At GLOBAL, we advocate for a hybrid model in which our team works closely alongside your established team of writers. With this model, GLOBAL writers can take on any number of projects to ensure your core EU MDR functions are moving toward all your critical deadlines. Bringing in a scalable partner, like GLOBAL, allows for your internal writing team to maintain a regular balance of work that is essential to their function; meanwhile, GLOBAL writers can take on work that would otherwise overwhelm your team. In the most ideal scenarios, GLOBAL writers work as extension of your internal team: we can coordinate across cross-functional stakeholders, manage project timelines, provide robust NB responses, and consult on important strategy decisions. In this hybrid model, GLOBAL can partner with your internal team to ensure everyone’s workload remains reasonable and achievable.
This model gives you the best of both worlds: the continuity of internal oversight and the agility of an external partner. It enables your internal experts to focus on areas that truly require attention, while providing the scalability needed to handle sudden shifts in volume, staffing, or regulatory expectations. This approach also reduces long-term staffing risk by avoiding the need to hire permanent resources for temporary surges.
Getting Started with Strategic Outsourcing
It is best to begin with a structured internal review. Identify your upcoming workload: CER updates, PMCF documentation, PSURs, new product development needs, and NB response commitments. Map your internal resourcing capacity against those requirements. If you find that the current workload exceeds the capacity of your current team, you should consider partnering with a vendor for continued support.
When developing a new relationship with a vendor, you may ask to begin a pilot project to better assess fit and process alignment. Choose a deliverable to evaluate turnaround time, communication, and document quality. A successful pilot can serve as a model for broader collaboration.
How GLOBAL Can Support Your EU MDR Program
GLOBAL works with manufacturers of varying sizes and therapeutic areas to provide comprehensive support for EU MDR deliverables. Our team delivers high-quality CERs, PMCF plans and reports, literature reviews, and notified body response packages on tight timelines.
We integrate with your team as a true extension of your capabilities; not just providing documents, but aligning with your internal standards, timelines, and expectations. Our writers, reviewers, and regulatory experts bring both MDR-specific experience and a commitment to quality, communication, and transparency.
Contact us today to learn how a flexible outsourcing partnership can help your internal team stay focused and your EU MDR compliance program stay on track.
