The Hidden MDR and IVDR Burden: Why Document-First Systems Fail MedTech Compliance

Medical device executives are feeling the pressure created by MDR and IVDR. What is less visible is why the burden keeps increasing, teams fall behind, and early AI initiatives collapse. The underlying issue is not simply regulatory complexity, but a content ecosystem that cannot sustain continuous evidence, multilingual alignment, or data-driven regulatory expectations. Part 1 of this two-part series examines that root cause and the structural barriers that now define the MedTech landscape.

Medical device manufacturers have spent the last decade watching the regulatory landscape tighten, most dramatically with Medical Device Regulation (MDR) and In Vitro Device Regulation (IVDR).

With the introduction of these regulations, what was once a cyclical, document-heavy exercise is being pushed toward a continuous, evidence-driven obligation that reaches across clinical, quality, regulatory, supply chain, and even commercial domains.

 The reality, however, is far from uniform. Regulations are unevenly interpreted, and Notified Bodies apply expectations inconsistently, creating a landscape that is both unclear and highly variable.

Even so, the direction of travel is unmistakable. The shift toward continuous oversight and reporting is accelerating, reshaping how manufacturers must plan, resource, and operate, whether the ecosystem is ready for it or not.

Industry reports show MDR/IVDR maintenance costs rising between 40 and 70 percent, with some manufacturers spending close to €100,000 per product per year simply to remain compliant. MedTech Europe’s 2024 analysis indicates that total certification and maintenance costs have increased by as much as 100 percent.

At the center of this burden is the sheer volume and complexity of technical documentation required to demonstrate conformity under MDR. Manufacturers struggle to maintain consistent CERs, PMCF updates, risk files, SSCPs, and multilingual IFUs, and any misalignment triggers additional clarification cycles with Notified Bodies.

These cycles, combined with rising NB fees, only intensify the cost and workload. Yet this is also where the opportunity lies. Modernizing internal content platforms, improving evidence alignment, and reducing dependency on NB-driven rework allow organizations to manage their technical documentation far more efficiently. Manufacturers that strengthen their internal content operations spend less time resolving documentation inconsistencies, less money navigating NB reviews and more time moving products forward.

Source: MedTech Europe Report

Seen from the C-suite, the pattern is familiar: rework spirals out of control, global submissions become increasingly difficult to coordinate across regions, PMS updates take months, teams duplicate effort across functions, evidence drifts over time. Early AI initiatives struggle as well, not because the models are weak, but because the underlying content lacks the structure, consistency, and context required for reliable interpretation.

But at the core, what stands in the way of compliance, and undermines progress, is the industry’s fragmented, unstructured approach to evidence and content. Siloed teams, disconnected evidence systems, and AI pilots failing on poor data highlight that the real barrier is not a lack of technology but a lack of a solid content foundation.

Most organizations are still living in a document-first world built on OCR-scanned legacy files, inconsistent templates, uncontrolled network storage spaces, and network drives full of static PDFs with no context, no metadata, and no relationships between content types. That era is ending, not because companies want to modernize, but because MDR and IVDR have made the old operating model impossible to scale.

MDR and IVDR did not create this problem. They exposed it.

The sheer volume of mandatory documentation required for compliance has grown dramatically, fundamentally reshaping the operational landscape for medical device companies. This is no longer a matter of adding a few more PDFs to a technical file.

The regulatory expectations are clear. Articles 83–86 of MDR, Annex III, and the equivalent IVDR sections demand:

• Active post-market surveillance, not passive reporting
• Continuous Post-Market Clinical Follow-up (PMCF) for almost all devices. Manufacturers must show they are learning from real-world use. PMCF is no longer a “high-risk device” activity. It is continuous, evidence-driven, and closely scrutinized.
• Annual or biennial Periodic Safety Update Reports (PSUR), with aligned evidence. Sales data, usage data, signals, vigilance trends, PMCF results, benefit-risk updates, mitigations, and CAPAs must align perfectly. Any inconsistency between documents is an audit finding waiting to happen.
• Tighter vigilance timelines, including 15-day reporting for serious incidents. Serious incidents must be reported in as little as 15 days. Trend reporting is now mandatory. Manufacturers must maintain real-time oversight of global complaints, service data, and field signals.
• Unique Device Identifier (UDI) traceability across global supply chains. UDI is now embedded into the supply chain, labeling, marketing, IFUs, packaging, ERP, and downstream distributors.
• European database for medical devices (EUDAMED) submissions, using structured, validated data formats across six modules. For most manufacturers, this has meant duplicating effort across national systems and the evolving EU environment.
• Multilingual Systems Security Certified Practitioner (SSCP), readable and accessible to patients.

More data + more updates + more scrutiny = more cost and more risk.

None of these documents exists in isolation. Each one cross-references another and must stay aligned. Manual alignment across multiple languages and formats is nearly impossible at this scale, especially when PMS cycles shorten and evidence updates become continuous. 

Many manufacturers now dedicate three to four months per year to updating PMS documentation alone, often only to find inconsistencies during internal reviews, NB audits, or after products reach the market. The strain is showing across the entire ecosystem. 

Many companies are still exploring how AI can ease regulatory pressures, testing approaches like automated literature reviews, rapid CER updates, RAG-based SSCP drafting, and faster evidence checks. Across EMEA and the Americas, teams continue to experiment with AI for summarizing PMCF findings, checking consistency across CER, IFU, and SSCP, and drafting submission sections, with most organizations just beginning to tap into its potential.

Most pilots are failing or have failed. Not because the algorithms were weak, but because the content they were asked to interpret was never designed for machines. PDFs flatten meaning. OCR introduces errors. Templates drift. Claims evolve with no historical traceability. Terminology varies across regions and subsidiaries. Risk mitigations are phrased differently each year. Multilingual variants multiply inconsistencies.

Most content ecosystems in MedTech predate modern regulatory expectations entirely. PDFs stored in scattered repositories. Word files passed through email. Local copies with conflicting edits. No semantic tagging. No consistent metadata. No explicit relationships between claims, evidence, risks, mitigations, or clinical outcomes. Dozens of near-duplicate documents rewritten manually every year.

MDR/IVDR didn’t cause this. They revealed that compliance is being managed through documents, not knowledge. And poorly structured, unstructured or narrative-style documents at that.

MedTech Europe’s policy analysis is explicit: after nearly seven years of MDR/IVDR implementation, the system remains unpredictable, fragmented, and unsustainable. Manufacturers, NBs, and regulators all point to the same issue: information ecosystems are not fit for purpose.

These trends reflect operational overload, not scientific failure.

Other industry surveys paint a similar picture. Manufacturers are withdrawing devices from the EU, delaying innovation pipelines, cancelling product developments, and struggling with NB bottlenecks, not because the science is insufficient, but because the documentation and evidence burden is unworkable in a document-centric system.

Key findings include:

• Decline in research and development: 53% of companies reduced R&D projects, particularly in the field of in-vitro diagnostics.
• Market access for innovations is at risk: Over 40% no longer launch new products in the EU, but in the USA and other regions.
• Production relocation: One third of companies plan to relocate production sites out of the EU.
• Supply gaps for orphan devices: Two-thirds of orphan device manufacturers have already had to discontinue products.

Source: Impact of EU Regulations MDR (2017/745) and IVDR (2017/746) on innovation, competitiveness and security of supply in the EU – Results of an industry survey 2025

The system is failing under its own weight. The survey showed that compliance in the industry is managed by documents, not actual knowledge, and document-centric models cannot keep up.

Regulatory Pressure Area	What Changed Under MDR/IVDR	Why It Matters
Up-classification and Expanded Scope	New rules elevate devices such as spinal implants, surgical meshes, nanomaterials, software (Rule 11), substance-based devices, and even aesthetic products. Accessories now require full technical files	Dramatically increased evidence requirements, tighter clinical justification, continuous CER and PMCF updates. Document-first systems cannot sustain this level of change
Higher Clinical Evidence and PMCF Expectations	Equivalence claims are heavily restricted. PMCF is mandatory for most devices. CERs must be continuously updated with PMCF findings, real-world performance, and systematic literature reviews	Creates a permanent evidence lifecycle instead of periodic updates. Misalignment across CER, SSCP, IFU, and risk files becomes a major audit risk when content is unstructured
Combination Products and Article 117 Obligations	Pharma–device combination products now require Notified Body Opinion for device components. EMA reports that 25 percent of MAAs include such combinations; 75 percent of these require NB review	Pharma and device evidence must align perfectly. Risk, clinical claims, and labeling must stay consistent across two regulatory regimes. Document-first models cannot maintain this alignment reliably
Expanded Supply Chain Responsibilities	Importers, distributors, and authorized representatives must verify UDI, manage documentation, support recalls, and ensure conformity. Manufacturers must maintain liability coverage	Compliance now extends across multiple economic operators. Fragmented content increases inconsistency, slows recalls, and raises regulatory risk
Notified Body Capacity Constraints	NBs face stricter competency requirements, joint audits, unannounced inspections, and heavier evidence review obligations. Many manufacturers experience delays or forced NB switches	Inconsistent or unstructured documentation increases NB queries, prolongs reviews, and delays market access. Structured content reduces clarification loops
EUDAMED and UDI Fragmentation	EUDAMED is still only partially functional, requiring dual reporting. UDI must remain synchronized across ERP, labeling, national databases, distributors, and the EU system	Every copy of data increases the chance of inconsistency. Document-first ecosystems cannot ensure alignment across all stakeholders and systems

The conclusion is uncomfortable but unavoidable. If the industry is going to meet the rising regulatory burden, accelerate submissions, and make AI deliver on its promise, the foundation must change.

Part 2 of this series will present that foundation. It will show how structured, governed, and machine-readable content transforms regulatory operations, accelerates PMS and submission cycles, and finally enables AI to deliver reliable value.