Case Study: How MDx Enabled Argen’s Successful Transition to MDR CE Marking for Dental Alloys

The challenge: transitioning legacy dental alloys to MDR

Transitioning Argen’s dental alloy portfolio to Regulation (EU) 2017/745 (MDR) required bridging significant gaps between the former MDD framework and the reinforced MDR requirements. The devices are intended for use in the fabrication of full-cast and ceramic-veneered restorations (porcelain-fused-to-metal), including crowns, bridges, and removable partial dentures, by dentists and dental laboratory technicians.

As a dental materials manufacturer, Argen faced the additional challenge of structuring and maturing core regulatory processes, particularly in clinical evaluation, post-market surveillance, biological evaluation, and risk management. In parallel, the project required the resolution of major and minor non-conformities previously raised by the Notified Body, ensuring a robust, defensible, and audit-ready MDR transition.

MDx approach: a structured pathway for MDR transition

Strengthening the clinical evaluation framework

First, MDx developed the clinical evaluation framework to ensure full alignment with MDR requirements. Particular emphasis was placed on consistency between intended purpose, risk management, clinical evidence, and post-market activities. This work directly enabled the closure of previously identified clinical evaluation non-conformities

Structuring PMS system

Next, post-market surveillance and vigilance procedures were reviewed and restructured with a clear distinction between proactive and reactive PMS activities. The scope included the PMS plan, data collection and trending, PSUR, and PMCF planning.

Vigilance processes were clarified and strengthened, including serious incident reporting, Field Safety Corrective Actions (FSCA), trend reporting, and Field Safety Notices (FSNs), supporting systematic lifecycle monitoring and closure of PMS-related findings.

Aligning risk management with MDR and ISO 14971 requirements

In parallel, MDx supported the review and alignment of risk management documentation with MDR and ISO 14971 requirements, ensuring clear traceability between identified hazards, risk control measures, clinical evidence, biological evaluation, and information supplied to the user.

Establishing MDR-compliant biological evaluation

The biological evaluation framework was developed and aligned with MDR and ISO 10993 requirements. This included defining the required biocompatibility tests and documenting the scientific rationale supporting their selection. MDx supported the identification of worst-case configurations and coordinated with qualified test laboratories during the development of the Biological Evaluation Plan (BEP). MDx subsequently prepared the Biological Evaluation Report (BER) and the associated Toxicological Risk Assessment (TRA), supported by a structured literature review and relevant biological testing, including extractables and leachables, cytotoxicity, and other applicable endpoints. All biological safety conclusions were fully integrated into the risk management file and technical documentation.

Aligning essential technical documentation

Finally, MDx contributed to the development, alignment, and consolidation of essential technical documentation, including Device Description and Specifications (DDS), labelling, Instructions for Use (IFUs), Risk Management (RM), Summary of Safety and Clinical Performance (SSCP), and Magnetic Resonance Imaging (MRI) safety documentation. This ensured consistency, clarity, and regulatory coherence across the technical file.

Results: strengthening regulatory readiness

• Critical technical documentation fully aligned with MDR requirements.
• Successful closure of major and minor non-conformities identified by BSI.
• Regulatory support for MDR certification of dental alloy product families, covering 600+ legacy implantable Class IIb devices.
• Significant enhancement of audit readiness and overall technical robustness of the documentation.
• Establishment of a solid regulatory foundation to support ongoing compliance throughout the device lifecycle.
• MDR certificate successfully issued by BSI.

Project timeline

March 2024 – September 2025

The project was delivered through coordinated regulatory workstreams covering clinical evaluation, risk management, PMS, biological evaluation, and technical documentation alignment – enabling efficient closure of findings and long-term compliance under MDR.

Client perspective

“I would like to say thank you to the MDx team for their professionalism and dedication (especially Andre M., Kara M., and Carlos G.) to deliver their project on-time and beyond expectation. We are a small digital dental company and have many processes that need to be improved or created to be compliant with EU MDR 2017/745. Both teams have spent countless hours to create, support, and review many documents including TD gap assessments, biocompatibility testing, Clinical Evaluation, Biological Evaluation, PMS, PSUR, PMCF, surveys, and more to mend the EU MDR gap.

Without your dedication and collaboration, we wouldn’t have been able to deliver this level of quality. I look forward to more excellent work from the team. Thanks for your continued support and feedback as well as offer your own experience, expertise through past interactions with Notified Bodies. Together, we have successfully fixed a 2021 major and minor non-conformance on clinical evaluation and PMS with BSI. Our journey continues with the current EU MDR Technical Documentation Review for a product family of over 600 products with BSI. I am looking forward to more achievements and future collaboration between our teams.”

Trish L. Winterburn | Regulatory Affairs | Deputy PRRC & Regulatory Compliance

“MDx’s expertise is top-notch and state-of-the-art in both IVDR, EU MDR and more. I have worked with MDx and the previous company of the current MDx CEO in both IVDR and EU MDR including other RA Support. The team is comprised of knowledgeable SMEs, experts including ex-BSI/ex-TUV SUD personnels. They are well trained, dedicated, professional and courteous. The feedback from Risk Management Review correlates to all points as required in the EU MDR 2017/745 for risk. Beyond RMF, MDx and I have partnered to fix BSI’s major/minor NCs and completed the UKCA/EU MDR Certification of 2 medical device families with over 600 devices. The service and expertise are top-notch and exceptional. Thanks and appreciate the team! “

Trish L. Winterburn | Regulatory Affairs | Deputy PRRC & Regulatory Compliance

Planning your transition from MDD to MDR?

MDx partners with medical device manufacturers worldwide to successfully place and maintain devices on the European Union market under Medical Device Regulation (EU) 2017/745 (MDR). Whether you are transitioning legacy devices or preparing for a first MDR submission, our team provides end-to-end regulatory support tailored to your portfolio and timelines.

Quick MDR Readiness Checklist

• Intended purpose clearly defined and aligned with classification and clinical strategy
• Risk management file compliant with ISO 14971, with full traceability to clinical, biological, and user information
• Clinical Evaluation Report (CER) aligned with MDR Annex XIV and supported by robust clinical evidence
• Biological Evaluation Plan and Report (BEP / BER) compliant with ISO 10993 and integrated into risk management
• Post-Market Surveillance (PMS) system in place, including PMCF and PSUR, as applicable
• Technical documentation complete and compliant with MDR Annex II and III
• Labeling and IFUs aligned with MDR requirements, including MRI safety where relevant
• Audit readiness confirmed through internal review or mock Notified Body assessment

MDx can lead, co-author, or independently review each of these activities, providing hands-on regulatory execution and strategic oversight to accelerate approval and reduce regulatory risk.

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MDx supports medical device manufacturers across Europe and outside Europe in navigating MDR through structured, risk-based, and Notified Body–focused regulatory strategies, helping you move efficiently from planning to certification and long-term compliance.