Frequently Asked Questions

• How are software applications classified under MDR and IVDR?

  Under MDR and IVDR, software classification is determined through a comprehensive assessment that considers the software’s intended purpose, functionality, and clinical impact, guided by the latest MDCG guidance documents. For MDR, Rule 11 applies primarily, classifying software into Class I, IIa, IIb, or III based on risk, especially when the software provides diagnostic or therapeutic decision support that could cause serious or irreversible harm. For IVDR, multiple rules may apply—such as Rule 1 for high-risk infectious disease software (Class D), Rule 2 for blood and life-threatening conditions (Classes C or D), and Rule 3 for genetic testing and companion diagnostics (mainly Class C)—with the classification depending on the specific use, influence on the device, and the risk posed to patients or public health. Our assessments incorporate these rules, along with MDCG guidance (2019-11, 2021-24, 2019-16, and 2023-1), ensuring accurate classification and the appropriate regulatory pathway.

• What documentation is required for IEC 62304 compliance?

  IEC 62304 documentation includes software development plans, risk management files, architecture and detailed design documentation, verification and validation protocols/reports, problem resolution documentation, and software configuration management plans. The exact documentation depends on your software safety classification (A, B, or C). MDx provides complete documentation templates and development support tailored to your software’s specific risk class.

• How do we validate AI/ML algorithms for regulatory approval?

   AI/ML algorithm validation requires demonstrating performance, robustness, and safety through comprehensive testing with diverse datasets, clear performance metrics, and risk mitigation strategies. For regulatory approval, you need documentation of the algorithm design, training data characteristics, performance metrics, limitations, and clinical validation evidence. MDx develops custom validation protocols specific to AI technologies that satisfy both current regulatory requirements and emerging AI regulations.

• How does the EU AI Act affect medical software development?

  The EU AI Act introduces risk-based classifications and requirements for AI systems, with medical AI often falling into “high-risk” categories requiring robust risk management, data governance, and transparency measures. While harmonization with MDR/IVDR is ongoing, manufacturers need to prepare for additional documentation, testing, and post-market monitoring specific to AI components. MDx provides gap assessments and compliance strategies to align your development processes with both medical device regulations and the AI Act.

• What clinical evidence is required for SaMD approval?

  Clinical evidence requirements for SaMD depend on its classification and claims but typically include demonstration of clinical performance (IVDR) or clinical benefit (MDR), performance in the target population, and safety in clinical use. This may involve literature reviews, analytical validation, clinical performance studies, and/or real-world performance data. MDx designs targeted clinical evidence strategies that align with your software’s specific regulatory pathway and risk classification.

• How do you manage post-market surveillance for software that undergoes frequent updates?

  Post-market surveillance for frequently updated software requires a robust change management process, clear documentation of version changes, significance assessments for each update, continuous performance monitoring, and regular safety reporting. MDx develops comprehensive PMS plans specific to software products, including criteria for determining when updates require regulatory notification or new conformity assessment.

Frequently Asked Questions

• What is the difference between a clinical trial and an IVD performance study?

  While both evaluate device performance, IVD performance studies follow specific regulations (IVDR, ISO 20916) rather than traditional clinical trial frameworks (ICH-GCP). IVD studies typically focus on evaluating an assay’s clinical performance using existing or newly collected samples, rather than testing interventions on patients.

• Can MDx handle ethics committee and competent authority submissions?

  Yes, we manage all aspects of ethics committee (EC/IRB) submissions and competent authority applications. Our team has a 100% success rate in obtaining approvals across multiple European countries for IVDR performance studies.

• Does MDx offer legal representation for IVD clinical studies in Europe?

  Yes, we provide full legal representation services for non-EU sponsors conducting studies under IVDR Article 58. This includes handling all regulatory communications, safety reporting, and compliance responsibilities.

• What is a CPSP under IVDR?

  A Clinical Performance Study Protocol (CPSP) is a mandatory document for IVD performance studies under IVDR. It details study design, objectives, participant selection, sample handling, statistical analysis, and quality procedures in compliance with ISO 20916 and IVDR Annex XIII/XIV requirements.

• How does MDx handle safety reporting in IVD performance studies?

  We implement robust systems for monitoring and reporting adverse events and device deficiencies according to IVDR requirements, with clear escalation pathways, reporting timelines, and documentation procedures.

• Can you support multi-country IVD studies?

  Absolutely. We have extensive experience coordinating studies across multiple countries, harmonizing submissions, and managing site networks throughout Europe, North America, and APAC.

Frequently Asked Questions

• How does IVDR classify NGS-based tests?

  Most NGS-based diagnostic tests fall into IVDR Class C due to their intended purpose (often providing high-risk individual risk information) or Class D if used for infectious disease with high public health risk. Classification depends on the specific claims, intended use, and risk profile of your test.

• What are the key challenges in validating NGS bioinformatics pipelines?

  Key challenges include demonstrating consistent performance across diverse samples, validating variant calling accuracy, establishing version control, documenting algorithm specifications per IEC 62304, and proving clinical validity of detected variants. Our approach addresses each challenge with specialized protocols and documentation templates.

• How can laboratories transition from LDTs to IVDR-compliant NGS assays?

  Transitioning requires implementing a compliant 13485 QMS, developing comprehensive technical documentation, validating both wet lab and bioinformatics components, generating clinical evidence, and preparing for Notified Body assessment. MDx offers a structured transition program specifically for laboratories making this change.

• What experience does MDx have with NGS companion diagnostics?

  We have supported multiple NGS CDx programs that involved EMA consultation, pharmaceutically aligned clinical studies, and simultaneous FDA and IVDR submissions. Our expertise covers both IHC and NGS-based CDx strategies with indications spanning oncology, rare disease, and immunology.

• How do you validate the clinical performance of an NGS test?

  We design ISO 20916-compliant clinical performance studies that demonstrate the assay’s ability to correctly identify the clinical condition or genetic status or data is gathered through published experience in routine diagnostic testing. This involves careful study design, reference method comparison, site selection, sample processing protocols, and statistical analysis plans tailored to the specific NGS technology and claims.

• Can MDx support both commercial kit development and laboratory-developed NGS tests?

  Yes. We support both commercial IVD kit manufacturers and laboratories transitioning their in-house developed NGS assays to comply with IVDR. Our approach is tailored to each scenario, addressing the specific regulatory and technical requirements for your business model.

Frequently Asked Questions

• Is a Legal Representative required for EU clinical studies?

  Yes. Non-EU sponsors must appoint a Legal Representative established in the EU to conduct performance studies under the IVDR or clinical investigations under the MDR. MDx fulfills this role and supports submissions to National Competent Authorities and Ethics Committees.
  

• What’s the difference between an EU Authorised Representative and a Legal Representative?

  An EU Authorised Representative (EU AR) is required for placing devices on the EU market. A Legal Representative is required for conducting clinical studies (IVDR/MDR) in the EU by non-EU sponsors. MDx provides both services, ensuring consistent oversight throughout pre-market and study phases.

• Do I need both a UKRP and a UK Legal Representative?

  No. Unlike the EU, the UK does not require a separate Legal Representative for clinical investigations. However, non-UK manufacturers must appoint a UK Responsible Person (UKRP) to place devices or IVDs on the GB market. For clinical studies, while the UKRP is not legally required to support the trial, MHRA expects agreements between the device manufacturer and a UKRP, and MDx can act as your UKRP and provide regulatory support for UK-based studies.

• Q4: What is required to appoint MDx as an EU AR, UKRP, or Legal Representative?

  We will request:

  • A signed service agreement outlining responsibilities
  • Product and device scope
  • Access to up-to-date technical documentation
  • Sponsor or manufacturer contact points for regulatory communication
• Does MDx handle EUDAMED and MHRA registrations?

  Yes. We manage actor registration, UDI/device listings, and technical file updates in EUDAMED. We also register devices and manage submissions with the MHRA, including vigilance and post-market reporting under IVDR, MDR, and UK MDR.

Frequently Asked Questions

• How does MDx ensure AI-generated content meets IVDR requirements?

  Our AI tools assist with search, screening, and data extraction, but final analysis and conclusions are always developed and validated by our expert team of former Notified Body reviewers and PhD-level scientists. Every report undergoes a comprehensive quality check against MDCG 2022-2 and IVDR requirements.

• What literature databases do you use for scientific validity searches?

  Our AI-enhanced approach searches multiple databases simultaneously, including PubMed/MEDLINE, Embase, Cochrane Library, Web of Science, Google Scholar, and specialty databases relevant to your specific analyte. We also search for gray literature, clinical trial registries, and regulatory/government publications.

• How do you handle novel biomarkers with limited literature?

  For novel biomarkers, we expand searches to include related biomarkers, biological pathways, and preclinical data. Our AI tools can identify subtle connections in the scientific literature that might be missed through manual searches. We then work with you to determine if the available evidence is sufficient or if additional clinical evidence generation is needed.

• Can you update existing scientific validity documentation to meet IVDR requirements?

  Yes. We frequently help clients transition existing documentation to IVDR-compliant scientific validity reports. Our AI tools can rapidly analyze your current documentation, identify gaps, and generate updated reports that meet Annex XIII, Section 1.2.1 requirements.

• How quickly can you deliver scientific validity reports?

  Our AI-enhanced approach typically delivers reports 60% faster than traditional methods. Depending on complexity, reports can be completed in 1-2 weeks, compared to the industry standard of 4-8 weeks.

• Do you support MDCG 2022-2 and MEDDEV 2.7/1 Rev 4 compliance?

  Absolutely. Our methodology is fully aligned with both MDCG 2022-2 and the principles of MEDDEV 2.7/1 Rev 4, ensuring reports meet current regulatory expectations for systematic literature reviews and scientific validity assessment.

Frequently Asked Questions

• How does MDx approach QMS implementation differently from other consultants?

  Our quality experts have both Notified Body and industry experience, allowing us to implement systems that are both compliant and practical. We develop right-sized solutions based on your organization’s size, resources, and regulatory needs rather than imposing one-size-fits-all templates. Our dual expertise in both device and IVD regulations ensures your QMS addresses the specific requirements for your product types.

• Can MDx provide temporary quality management services during transitions?

  Yes. We offer interim quality management solutions, including part-time Quality Managers, remote QA support, and virtual teams to maintain compliance during organizational changes, growth phases, or gaps in staffing. These services can be particularly valuable during transitions between regulatory frameworks like IVDD to IVDR or MDD to MDR.

• How do you ensure our QMS will withstand Notified Body scrutiny?

  Our team includes former auditors from leading Notified Bodies who conduct thorough pre-certification assessments using the same approach and standards as official audits. This insider perspective ensures we address potential issues before your formal audit. For IVD manufacturers, we have specialists in Class C and D products who understand the heightened scrutiny these products receive.

• Does MDx support MDSAP certification?

  Absolutely. We have specific expertise in MDSAP requirements and provide gap assessments, documentation development, and audit preparation for all MDSAP participating regions (US, Canada, Brazil, Australia, and Japan). Our team has successfully guided multiple companies through MDSAP certification and surveillance audits.

• How do you approach risk management for different product types?

  We implement tailored risk management strategies based on your specific product type and technology. For IVDs, we focus on elements like risk of false results, clinical impact, and sample handling. For medical devices, we emphasize patient safety, device performance, and use-related risks. For software, we integrate ISO 14971 with IEC 62304 and cybersecurity requirements. In all cases, we ensure documentation meets applicable regulatory requirements.

• What makes MDx's mock audits more effective than self-assessment?

  Our mock audits are conducted by former Notified Body auditors who have performed hundreds of actual certification audits. They apply the same techniques, focus areas, and evaluation criteria used by leading NBs, providing authentic preparation that identifies issues self-assessments typically miss. We also tailor mock audits to your specific product types and regulatory frameworks (MDR, IVDR, FDA, MDSAP).