A Practical Guide for Medical Device Manufacturers
Regulatory compliance for dental products has become far more complex over the past decade. What was once a relatively straightforward pathway is now a demanding, lifecycle‑driven process that requires robust technical evidence, structured post‑market surveillance, and ongoing regulatory oversight.
For manufacturers bringing dental products to market—especially under the EU Medical Device Regulation (MDR) compliance is no longer a single milestone. It is a continuous obligation that influences product design, technical documentation, clinical evidence, and post‑market performance activities throughout the entire lifecycle.
From our experience as a CRO supporting medical device manufacturers, dental products often sit at the intersection of material science, clinical performance, and heightened regulatory expectations. This combination makes regulatory compliance both critical and increasingly challenging for manufacturers aiming to achieve and maintain market access.
What Regulatory Compliance Means for Dental Products
Dental products vs. dental medical devices
Many dental products are legally classified as medical devices, even when they are commonly perceived as materials or components. Items such as dental alloys, implantable components, restorative materials, and certain software‑driven solutions fall under medical device regulations when intended for a medical purpose.
This classification carries specific regulatory obligations for manufacturers, whether the product is used directly by clinicians or indirectly through dental laboratories.
Responsibility across the product lifecycle
Regulatory compliance extends far beyond initial approval. Manufacturers are responsible for:
- Defining and maintaining the intended purpose
- Ensuring ongoing safety and performance
- Monitoring post-market data
- Updating documentation as evidence evolves
Another key point is that compliance failures often arise not from missing documents, but from inconsistencies across lifecycle activities.
Why dental products face increased scrutiny
Dental devices frequently involve:
- Implantable or long-term contact materials
- Complex alloy compositions
- Large legacy portfolios originally certified under previous regulations
These factors increase expectations around clinical evidence, biological safety, and post-market surveillance.
Which Regulations Apply to Dental Medical Devices?
EU MDR and its impact
In the European Union, dental medical devices are governed by Regulation (EU) 2017/745 (MDR). Compared to the former Medical Device Directive, MDR introduces:
- Stronger clinical evidence requirements
- Enhanced post-market surveillance obligations
- Increased scrutiny from Notified Bodies
- Clearer expectations for technical documentation consistency
CE marking and UKCA considerations
For manufacturers placing devices on the EU and UK markets, both CE marking and UKCA marking require coordinated yet distinct regulatory strategies. Although the underlying principles are similar, the timelines, documentation requirements, and regulatory interactions can differ significantly between the EU MDR/IVDR and the UK regulatory framework.
FDA and global context
For companies operating globally, dental product compliance must often align with FDA expectations and other international frameworks. While this article focuses on EU MDR, a global regulatory strategy should aim for evidence reuse and lifecycle consistency across jurisdictions.
Regulatory Classification of Dental Products
How to determine classification
Under MDR, dental devices are classified based on:
- Intended purpose
- Duration of contact
- Invasiveness
- Implantable status
Many dental materials and alloys fall into higher-risk classes than expected, particularly when used in implantable or long-term applications.
Why classification drives regulatory strategy
Classification decisions affect:
- Conformity assessment routes
- Clinical evidence depth
- Post-market obligations
- Notified Body involvement
Misclassification early in development often leads to costly rework later.
Learning from Real-World MDR Transitions in Dental Products
Across MDR transition projects involving complex dental portfolios, one lesson consistently emerges: regulatory compliance succeeds when evidence, processes, and documentation are aligned from end to end.
Large dental product families require structured execution, clear ownership, and realistic timelines. Compliance is less about individual documents and more about how well the regulatory system functions as a whole.
If you want to see how these principles apply in practice, you can read our full case study on an MDR transition for dental products.
Core Regulatory Requirements for Dental Product Compliance
Technical documentation and conformity assessment
Regulatory compliance for dental products starts with technical documentation that clearly and consistently supports the device’s safety and performance. Under MDR, this documentation is reviewed as a single, connected system rather than as separate files.
Manufacturers must demonstrate that the device is well defined, risks are properly controlled, and clinical and biological evidence support the intended use. In practice, regulatory findings often arise not because documents are missing, but because different parts of the technical file are not fully aligned.
Clinical evaluation
Clinical evaluation must show that the dental device performs as intended and remains safe throughout its lifecycle. This assessment is typically based on a combination of clinical data, relevant scientific literature, and post-market evidence where available.
For dental devices, regulators closely scrutinize whether clinical claims align with the intended purpose and the conclusions from risk management activities. Any inconsistency between these elements is one of the most frequent causes of Notified Body questions during technical documentation review.
Biological evaluation and material safety
Biological evaluation is particularly important for dental materials that come into prolonged or permanent contact with the body. Manufacturers are expected to follow a structured, risk-based approach that justifies testing, addresses worst-case configurations, and integrates toxicological considerations where relevant.
Weak biological rationales or conclusions that are not reflected in risk management and labelling are frequent sources of non-conformities.
Risk management and traceability
Risk management under MDR is a continuous process, not a one-time activity. Regulators increasingly expect clear traceability between identified hazards, risk control measures, supporting clinical and biological evidence, and the information provided to users.
Consistency over time is critical. Risk management conclusions must remain aligned with clinical evaluation updates and post-market data as new information becomes available.
Labelling and instructions for use (IFUs)
Labelling and IFUs must accurately reflect the device’s intended use, residual risks, contraindications, and safety-related information. Inconsistencies between labelling and technical documentation are a common reason for regulatory findings.
Under MDR, labelling is assessed as a direct extension of the manufacturer’s risk and clinical conclusions, not as a standalone deliverable.
Post-Market Obligations for Dental Medical Devices
Post-Market Surveillance (PMS)
PMS systems must actively collect and analyse real-world data. This includes:
- Complaint handling
- Trend analysis
- Vigilance reporting
- Periodic safety updates
PMCF and PSUR
Depending on classification and risk, manufacturers may be required to implement:
- Post-Market Clinical Follow-up (PMCF)
- Periodic Safety Update Reports (PSUR)
Post-market data is not optional, it is central to demonstrating ongoing compliance.
Common Regulatory Compliance Challenges for Dental Products
Legacy devices and MDR transitions
Many dental products on the market today were originally certified under older regulatory frameworks. Transitioning these products to MDR often reveals gaps in:
- Clinical evidence
- PMS systems
- Biological evaluation rationale
- Documentation consistency
Portfolio-level complexity
For large dental portfolios, compliance challenges multiply. Managing hundreds of devices requires:
- Structured regulatory frameworks
- Harmonised documentation strategies
- Scalable post-market systems
This is where compliance often fails if not addressed strategically.
Notified Body expectations
Notified Bodies assess how well manufacturers control their products over time. Audit readiness depends on:
- Evidence coherence
- Lifecycle thinking
- Demonstrated control, not just document availability
The Role of a CRO in Dental Product Regulatory Compliance
Manufacturers involving a CRO
Manufacturers typically engage a CRO when:
- Internal teams need execution support
- Portfolios are large or complex
- Timelines are constrained
- Notified Body interactions intensify
Execution vs. advisory support
Advisory guidance alone is rarely sufficient under MDR. Effective CRO support combines:
- Hands-on document development
- Evidence generation and alignment
- Practical experience with audits and regulatory reviews
Supporting market access
A CRO working alongside manufacturers can help:
- Reduce regulatory risk
- Accelerate conformity assessment
- Maintain long-term compliance across the product lifecycle
Key Takeaways: Placing Dental Medical Devices on the Market
Manufacturers that treat compliance as a strategic function (supported by the right expertise) are better positioned to place and maintain their products on the market without unnecessary delays or regulatory setbacks.
Regulatory compliance for dental products is:
A lifecycle commitment, not a one-off project
Heavily dependent on consistency and traceability
Increasingly scrutinised under MDR
If you’re preparing to bring a dental or medical device to market and require execution‑level CRO support, our team partners directly with manufacturers to provide comprehensive, end‑to‑end regulatory compliance services.
